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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03180294
Other study ID # NRG-CC004
Secondary ID NCI-2017-00344NR
Status Completed
Phase Phase 2
First received
Last updated
Start date May 31, 2017
Est. completion date February 22, 2021

Study information

Verified date February 2022
Source NRG Oncology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase II randomized trial studies how well bupropion hydrochloride works in improving sexual desire in women with breast or gynecological cancer. Bupropion hydrochloride may work by boosting sexual desire, energy, or motivation without causing intolerable or undesirable side effects.


Description:

PRIMARY OBJECTIVES: I. Measure the ability of two dose levels of bupropion hydrochloride (bupropion), 150 or 300 mg of extended release, to improve sexual desire more than a placebo at 9 weeks (8 weeks on the target dose) as measured by the desire subscale of the female sexual function index (FSFI). SECONDARY OBJECTIVES: I. Evaluate the side effects of 150 and 300 mg bupropion extended release and differentiate these side effects from those observed in the placebo arm. II. Evaluate the effect of 150 and 300 mg of bupropion extended release on the Patient Reported Outcomes Measurement Information System (PROMIS) fatigue scale, PROMIS sexual desire and satisfaction measure, patient health questionnaire (PHQ)-4, and the FSFI total score, at 5 and 9 weeks, as well as the desire subscale score of the FSFI at 5 weeks. III. Evaluate the effect of 150 and 300 mg of bupropion extended release on the global impression of change scale and the patient's perception of risk versus (vs.) benefit at 5 weeks (4 weeks at target dose) and 9 weeks (8 weeks at target dose). Patients are randomized to 1 of 3 arms.


Recruitment information / eligibility

Status Completed
Enrollment 230
Est. completion date February 22, 2021
Est. primary completion date February 22, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - PRIOR TO STEP 1 REGISTRATION - Score of < 9 on the PHQ-4 - Patients must have a FSFI desire subscale baseline score less than 3.3 - NOTE-Both the PHQ-4 and FSFI must be completed by the patient and data entered in Oncology Patient Enrollment Network (OPEN) at Step 1 registration to determine eligibility - Diagnosis of breast or gynecologic cancer [examples are lobular carcinoma in situ (LCIS),ductal carcinoma in situ (DCIS), invasive breast, ovarian, endometrial, vulvar, cervical and vaginal] - Completed definitive therapy consisting of surgery, chemotherapy or radiation therapy at least 180 days ago (may continue on Herceptin or endocrine therapy) - Post menopausal as defined by at least ONE of the following: - 12 months (365 days) without a period; - Bilateral oophorectomy; - Chemically induced menopause as long as there are no plans to stop during the study; - For women 57 and under, if at least one ovary and woman has had hysterectomy, must have follicle stimulating hormone (FSH) (> 30 mIU/mL) and estradiol in menopausal range per institution?s laboratory (< 10 for ultra sensitive assay: < 25-30 otherwise); - At least one ovary intact and 180 days without a period with FSH (> 30 mIU/mL) and estradiol in menopausal range per institution's laboratory (< 10 for ultra sensitive assay: < 25-30 otherwise); Note: Women 58 and older do not have to have hormonal tests. - History, physical and performance status of 2 or less within 180 days prior to registration - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN) - Total bilirubin =< 1.5 x ULN - Glomerular filtration rate > 90ml/min - For breast cancer patients only, endocrine therapies are allowed (such as aromatase inhibitors, but not current tamoxifen. Prior tamoxifen is permitted with a 30 day wash out period). ) - Vaginal estrogen is allowed, for all protocol disease sites, if dose equal to or less than that in estring (< 7.5 mcg) and it has been used for at least 30 days with no plans to stop or alter use during the course of the study - Antidepressants for mood and hot flashes, including selective serotonin reuptake inhibitors (SSRIs) will be allowed if patients have been on a stable dose for the last 60 days and the dose is not expected to change during the course of the study; only subthreshold or low dose antidepressants will be allowed (e.g. Effexor up to 75 mg or Lexapro 5-10 mg or Celexa 10- 20 mg) - The patient must provide study-specific informed consent prior to study entry/screening - Women who report that their motivation/desire for sexual intimacy has decreased since her cancer diagnosis - Able to swallow whole capsules - Proficient in English (due to number of questionnaires not validated in other languages) - Completion of the FSFI and PHQ-4; both questionnaires will be required and data entered at the time of step 1 registration - PRIOR TO STEP 2 RANDOMIZATION - Completion of the following baseline quality of life forms: PHQ-4, FSFI, PROMIS sexual function and satisfaction, PROMIS fatigue short form 8a, Impact of Treatment Scale, patient reported outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) items, and revised dyadic adjustment scale; these quality of life forms will be required and data must be entered in Medidata Rave at step 2 registration; if available at the time of step 1 registration, step 2 registration can take place immediately after step 1; women who do not currently have a partner do not have to complete the revised dyadic adjustment scale; enter "no partner" for this form Exclusion Criteria: - Untreated depression, major depressive disorder (MDD), suicidal ideations or anxiety disorders in the past 5 years per the medical chart based on Diagnostic and Statistical Manual (DSM) IV diagnoses - Seizure disorders - Current or history of anorexia or bulimia in the past 5 years - Allergy to bupropion - Use of drugs metabolized by CYP2D6 - Stage IV cancer - History of Parkinson's disease, multiple sclerosis or fibromyalgia - Extensive pelvic exenteration surgery, surgeries which include partial or total vaginectomy with or without reconstruction; radical vulvectomy with or without remove of clitoris - Women who are currently undergoing or planning to undergo reconstruction surgery during the course of the study; women who have completed reconstruction surgery must be 30 days from surgery - Oral or transdermal estrogen therapy is not allowed - Males are not permitted to participate - Patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs after chronic use - Patients who discontinue monoamine oxidase (MAO)-inhibitor (I)'s within 14 days prior to starting the investigational drug - Poorly controlled hypertension (systolic blood pressure [BP] >= 160 mmHg or diastolic BP >= 100 mmHg) on three or more readings in the past 12 months - Patients with active bipolar disorder - Patients with impaired decision making as determined by the treating physician - Concurrent use of bupropion - Concomitant invasive malignancy requiring treatment other than non-melanomatous skin cancer. - Previous or concurrent use of flibanserin.

Study Design


Intervention

Drug:
Bupropion 150 mg XL
By mouth
Placebo
By mouth

Locations

Country Name City State
United States Pali Momi Medical Center 'Aiea Hawaii
United States Queen's Cancer Center - Pearlridge 'Aiea Hawaii
United States The Cancer Center of Hawaii-Pali Momi 'Aiea Hawaii
United States University of New Mexico Cancer Center Albuquerque New Mexico
United States American Fork Hospital / Huntsman Intermountain Cancer Center American Fork Utah
United States Kaiser Permanente-Anaheim Anaheim California
United States Saint Joseph Mercy Hospital Ann Arbor Michigan
United States Kaiser Permanente-Deer Valley Medical Center Antioch California
United States Randolph Hospital Asheboro North Carolina
United States Duluth Clinic Ashland Ashland Wisconsin
United States MultiCare Auburn Medical Center Auburn Washington
United States Augusta University Medical Center Augusta Georgia
United States Rocky Mountain Cancer Centers-Aurora Aurora Colorado
United States Kaiser Permanente-Baldwin Park Baldwin Park California
United States Saint Louis Cancer and Breast Institute-Ballwin Ballwin Missouri
United States Flaget Memorial Hospital Bardstown Kentucky
United States Bronson Battle Creek Battle Creek Michigan
United States Northwell Health Imbert Cancer Center Bay Shore New York
United States Indu and Raj Soin Medical Center Beavercreek Ohio
United States Kaiser Permanente-Bellflower Bellflower California
United States Strecker Cancer Center-Belpre Belpre Ohio
United States Billings Clinic Cancer Center Billings Montana
United States Sanford Bismarck Medical Center Bismarck North Dakota
United States Prisma Health Cancer Institute - Spartanburg Boiling Springs South Carolina
United States Saint Alphonsus Cancer Care Center-Boise Boise Idaho
United States Rocky Mountain Cancer Centers-Boulder Boulder Colorado
United States Bozeman Deaconess Hospital Bozeman Montana
United States Essentia Health Saint Joseph's Medical Center Brainerd Minnesota
United States Harrison HealthPartners Hematology and Oncology-Bremerton Bremerton Washington
United States IHA Hematology Oncology Consultants-Brighton Brighton Michigan
United States Saint Joseph Mercy Brighton Brighton Michigan
United States Saint Joseph Regional Cancer Center Bryan Texas
United States Bryn Mawr Hospital Bryn Mawr Pennsylvania
United States Aurora Cancer Care-Southern Lakes VLCC Burlington Wisconsin
United States Cone Health Cancer Center at Alamance Regional Burlington North Carolina
United States Fairview Ridges Hospital Burnsville Minnesota
United States Saint Alphonsus Cancer Care Center-Caldwell Caldwell Idaho
United States IHA Hematology Oncology Consultants-Canton Canton Michigan
United States Saint Joseph Mercy Canton Canton Michigan
United States Saint Francis Medical Center Cape Girardeau Missouri
United States AtlantiCare Health Park-Cape May Court House Cape May Court House New Jersey
United States Physicians' Clinic of Iowa PC Cedar Rapids Iowa
United States Dayton Physicians LLC-Miami Valley South Centerville Ohio
United States Miami Valley Hospital South Centerville Ohio
United States Centralia Oncology Clinic Centralia Illinois
United States Cancer Center of Kansas - Chanute Chanute Kansas
United States Medical University of South Carolina Charleston South Carolina
United States IHA Hematology Oncology Consultants-Chelsea Chelsea Michigan
United States Saint Joseph Mercy Chelsea Chelsea Michigan
United States Cheyenne Regional Medical Center-West Cheyenne Wyoming
United States John H Stroger Jr Hospital of Cook County Chicago Illinois
United States Adena Regional Medical Center Chillicothe Ohio
United States Marshfield Clinic-Chippewa Center Chippewa Falls Wisconsin
United States Bethesda North Hospital Cincinnati Ohio
United States Good Samaritan Hospital - Cincinnati Cincinnati Ohio
United States TriHealth Cancer Institute-Anderson Cincinnati Ohio
United States TriHealth Cancer Institute-Westside Cincinnati Ohio
United States Hematology Oncology Consultants-Clarkston Clarkston Michigan
United States Newland Medical Associates-Clarkston Clarkston Michigan
United States Prisma Health Cancer Institute - Laurens Clinton South Carolina
United States Southeastern Medical Oncology Center-Clinton Clinton North Carolina
United States Penrose-Saint Francis Healthcare Colorado Springs Colorado
United States Columbus Oncology and Hematology Associates Inc Columbus Ohio
United States Doctors Hospital Columbus Ohio
United States Grant Medical Center Columbus Ohio
United States Riverside Methodist Hospital Columbus Ohio
United States The Mark H Zangmeister Center Columbus Ohio
United States Mercy Hospital Coon Rapids Minnesota
United States Carle on Vermilion Danville Illinois
United States Geisinger Medical Center Danville Pennsylvania
United States Dayton Physician LLC-Miami Valley Hospital North Dayton Ohio
United States Dayton Veterans Affairs Medical Center Dayton Ohio
United States Good Samaritan Hospital - Dayton Dayton Ohio
United States Miami Valley Hospital Dayton Ohio
United States Miami Valley Hospital North Dayton Ohio
United States Cancer Care Specialists of Illinois - Decatur Decatur Illinois
United States Decatur Memorial Hospital Decatur Illinois
United States Essentia Health - Deer River Clinic Deer River Minnesota
United States Delaware Health Center-Grady Cancer Center Delaware Ohio
United States Denver Health Medical Center Denver Colorado
United States Kaiser Permanente-Franklin Denver Colorado
United States National Jewish Health-Main Campus Denver Colorado
United States Rocky Mountain Cancer Centers-Midtown Denver Colorado
United States Rocky Mountain Cancer Centers-Rose Denver Colorado
United States SCL Health Saint Joseph Hospital Denver Colorado
United States The Women's Imaging Center Denver Colorado
United States Broadlawns Medical Center Des Moines Iowa
United States Iowa Lutheran Hospital Des Moines Iowa
United States Iowa Methodist Medical Center Des Moines Iowa
United States Medical Oncology and Hematology Associates-Des Moines Des Moines Iowa
United States Mercy Medical Center - Des Moines Des Moines Iowa
United States Ascension Saint John Hospital Detroit Michigan
United States Essentia Health Saint Mary's - Detroit Lakes Clinic Detroit Lakes Minnesota
United States Cancer Center of Kansas - Dodge City Dodge City Kansas
United States Kaiser Permanente Dublin Dublin California
United States Essentia Health Cancer Center Duluth Minnesota
United States Essentia Health Saint Mary's Medical Center Duluth Minnesota
United States Miller-Dwan Hospital Duluth Minnesota
United States Prisma Health Cancer Institute - Easley Easley South Carolina
United States Great Lakes Cancer Management Specialists-Doctors Park East China Township Michigan
United States Marshfield Medical Center-EC Cancer Center Eau Claire Wisconsin
United States Fairview Southdale Hospital Edina Minnesota
United States Crossroads Cancer Center Effingham Illinois
United States AtlantiCare Surgery Center Egg Harbor Township New Jersey
United States Cancer Center of Kansas - El Dorado El Dorado Kansas
United States Mountain Blue Cancer Care Center - Swedish Englewood Colorado
United States Swedish Medical Center Englewood Colorado
United States Green Bay Oncology - Escanaba Escanaba Michigan
United States Essentia Health Cancer Center-South University Clinic Fargo North Dakota
United States Sanford Broadway Medical Center Fargo North Dakota
United States Sanford Roger Maris Cancer Center Fargo North Dakota
United States Genesee Cancer and Blood Disease Treatment Center Flint Michigan
United States Genesee Hematology Oncology PC Flint Michigan
United States Genesys Hurley Cancer Institute Flint Michigan
United States Hurley Medical Center Flint Michigan
United States Aurora Health Center-Fond du Lac Fond Du Lac Wisconsin
United States Kaiser Permanente-Fontana Fontana California
United States Trinity Regional Medical Center Fort Dodge Iowa
United States Florida Gynecologic Oncology Fort Myers Florida
United States Regional Cancer Center-Lee Memorial Health System Fort Myers Florida
United States Cancer Center of Kansas - Fort Scott Fort Scott Kansas
United States Essentia Health - Fosston Fosston Minnesota
United States Atrium Medical Center-Middletown Regional Hospital Franklin Ohio
United States Dayton Physicians LLC-Atrium Franklin Ohio
United States Kaiser Permanente-Fremont Fremont California
United States Kaiser Permanente-Fresno Fresno California
United States Unity Hospital Fridley Minnesota
United States Gibbs Cancer Center-Gaffney Gaffney South Carolina
United States Tidelands Georgetown Memorial Hospital Georgetown South Carolina
United States Aurora Health Care Germantown Health Center Germantown Wisconsin
United States MultiCare Gig Harbor Medical Park Gig Harbor Washington
United States National Jewish Health-Western Hematology Oncology Golden Colorado
United States Southeastern Medical Oncology Center-Goldsboro Goldsboro North Carolina
United States Aurora Cancer Care-Grafton Grafton Wisconsin
United States CHI Health Saint Francis Grand Island Nebraska
United States Mercy Health Saint Mary's Grand Rapids Michigan
United States Spectrum Health at Butterworth Campus Grand Rapids Michigan
United States Central Care Cancer Center - Great Bend Great Bend Kansas
United States Benefis Healthcare- Sletten Cancer Institute Great Falls Montana
United States North Colorado Medical Center Greeley Colorado
United States Aurora BayCare Medical Center Green Bay Wisconsin
United States Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay Wisconsin
United States Saint Vincent Hospital Cancer Center Green Bay Green Bay Wisconsin
United States Cone Health Cancer Center Greensboro North Carolina
United States Dayton Physicians LLC-Wayne Greenville Ohio
United States Prisma Health Cancer Institute - Butternut Greenville South Carolina
United States Prisma Health Cancer Institute - Eastside Greenville South Carolina
United States Prisma Health Cancer Institute - Faris Greenville South Carolina
United States Saint Francis Cancer Center Greenville South Carolina
United States Saint Francis Hospital Greenville South Carolina
United States Wayne Hospital Greenville Ohio
United States Gibbs Cancer Center-Pelham Greer South Carolina
United States Prisma Health Cancer Institute - Greer Greer South Carolina
United States Academic Hematology Oncology Specialists Grosse Pointe Woods Michigan
United States Great Lakes Cancer Management Specialists-Van Elslander Cancer Center Grosse Pointe Woods Michigan
United States Michigan Breast Specialists-Grosse Pointe Woods Grosse Pointe Woods Michigan
United States Gulfport Memorial Hospital Gulfport Mississippi
United States Kaiser Permanente - Harbor City Harbor City California
United States Geisinger Medical Center-Cancer Center Hazleton Hazleton Pennsylvania
United States Margaret R Pardee Memorial Hospital Hendersonville North Carolina
United States Essentia Health Hibbing Clinic Hibbing Minnesota
United States South Carolina Cancer Specialists PC Hilton Head Island South Carolina
United States Hawaii Cancer Care Inc - Waterfront Plaza Honolulu Hawaii
United States Hawaii Cancer Care Inc-Liliha Honolulu Hawaii
United States Kaiser Permanente Moanalua Medical Center Honolulu Hawaii
United States Kapiolani Medical Center for Women and Children Honolulu Hawaii
United States Queen's Cancer Cenrer - POB I Honolulu Hawaii
United States Queen's Cancer Center - Kuakini Honolulu Hawaii
United States Queen's Medical Center Honolulu Hawaii
United States Straub Clinic and Hospital Honolulu Hawaii
United States The Cancer Center of Hawaii-Liliha Honolulu Hawaii
United States University of Hawaii Cancer Center Honolulu Hawaii
United States Cancer Center of Kansas-Independence Independence Kansas
United States Kaiser Permanente-Irvine Irvine California
United States Southeastern Medical Oncology Center-Jacksonville Jacksonville North Carolina
United States Essentia Health - Jamestown Clinic Jamestown North Dakota
United States West Michigan Cancer Center Kalamazoo Michigan
United States Northwest Cancer Clinic Kennewick Washington
United States Aurora Cancer Care-Kenosha South Kenosha Wisconsin
United States First Dayton Cancer Care Kettering Ohio
United States Greater Dayton Cancer Center Kettering Ohio
United States Kettering Medical Center Kettering Ohio
United States Cancer Center of Kansas-Kingman Kingman Kansas
United States Gundersen Lutheran Medical Center La Crosse Wisconsin
United States Marshfield Clinic - Ladysmith Center Ladysmith Wisconsin
United States Kaiser Permanente-Rock Creek Lafayette Colorado
United States Northwell Health/Center for Advanced Medicine Lake Success New York
United States Sparrow Hospital Lansing Michigan
United States Lawrence Memorial Hospital Lawrence Kansas
United States Kansas Institute of Medicine Cancer and Blood Center Lenexa Kansas
United States Minimally Invasive Surgery Hospital Lenexa Kansas
United States Geisinger Medical Oncology-Lewisburg Lewisburg Pennsylvania
United States Lewistown Hospital Lewistown Pennsylvania
United States Saint Joseph Hospital East Lexington Kentucky
United States Cancer Center of Kansas-Liberal Liberal Kansas
United States Rocky Mountain Cancer Centers-Littleton Littleton Colorado
United States Hope Cancer Clinic Livonia Michigan
United States Saint Mary Mercy Hospital Livonia Michigan
United States Logan Regional Hospital Logan Utah
United States Kaiser Permanente-Lone Tree Lone Tree Colorado
United States Rocky Mountain Cancer Centers-Sky Ridge Lone Tree Colorado
United States Kaiser Permanente Los Angeles Medical Center Los Angeles California
United States Kaiser Permanente-Cadillac Los Angeles California
United States UCLA / Jonsson Comprehensive Cancer Center Los Angeles California
United States McKee Medical Center Loveland Colorado
United States Great Lakes Cancer Management Specialists-Macomb Medical Campus Macomb Michigan
United States Michigan Breast Specialists-Macomb Township Macomb Michigan
United States Cancer Center of Kansas-Manhattan Manhattan Kansas
United States Holy Family Memorial Hospital Manitowoc Wisconsin
United States OhioHealth Mansfield Hospital Mansfield Ohio
United States Fairview Clinics and Surgery Center Maple Grove Maple Grove Minnesota
United States Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota
United States Saint John's Hospital - Healtheast Maplewood Minnesota
United States Marietta Memorial Hospital Marietta Ohio
United States Aurora Bay Area Medical Group-Marinette Marinette Wisconsin
United States Saint Vincent Hospital Cancer Center at Marinette Marinette Wisconsin
United States OhioHealth Marion General Hospital Marion Ohio
United States Marshfield Medical Center-Marshfield Marshfield Wisconsin
United States Cancer Center of Kansas - McPherson McPherson Kansas
United States Cone Heath Cancer Center at Mebane Mebane North Carolina
United States Riddle Memorial Hospital Media Pennsylvania
United States Aurora Cancer Care-Milwaukee Milwaukee Wisconsin
United States Aurora Saint Luke's Medical Center Milwaukee Wisconsin
United States Aurora Sinai Medical Center Milwaukee Wisconsin
United States Abbott-Northwestern Hospital Minneapolis Minnesota
United States Health Partners Inc Minneapolis Minnesota
United States Hennepin County Medical Center Minneapolis Minnesota
United States Marshfield Clinic-Minocqua Center Minocqua Wisconsin
United States Community Medical Hospital Missoula Montana
United States Kaiser Permanente-Modesto Modesto California
United States Monticello Cancer Center Monticello Minnesota
United States Knox Community Hospital Mount Vernon Ohio
United States Intermountain Medical Center Murray Utah
United States Saint Alphonsus Medical Center-Nampa Nampa Idaho
United States Louisiana State University Health Science Center New Orleans Louisiana
United States University Medical Center New Orleans New Orleans Louisiana
United States Cancer Center of Western Wisconsin New Richmond Wisconsin
United States New Ulm Medical Center New Ulm Minnesota
United States Lenox Hill Hospital New York New York
United States Memorial Sloan Kettering Cancer Center New York New York
United States Christiana Care Health System-Christiana Hospital Newark Delaware
United States Helen F Graham Cancer Center Newark Delaware
United States Licking Memorial Hospital Newark Ohio
United States Medical Oncology Hematology Consultants PA Newark Delaware
United States Cancer Center of Kansas - Newton Newton Kansas
United States Lakeland Hospital Niles Niles Michigan
United States Kaiser Permanente-Oakland Oakland California
United States Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls Wisconsin
United States McKay-Dee Hospital Center Ogden Utah
United States Mercy Hospital Oklahoma City Oklahoma City Oklahoma
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Kaiser Permanente-Ontario Ontario California
United States Vince Lombardi Cancer Clinic - Oshkosh Oshkosh Wisconsin
United States Kaiser Permanente - Panorama City Panorama City California
United States Paoli Memorial Hospital Paoli Pennsylvania
United States Essentia Health - Park Rapids Park Rapids Minnesota
United States Cancer Center of Kansas - Parsons Parsons Kansas
United States 21st Century Oncology-Pontiac Pontiac Michigan
United States Newland Medical Associates-Pontiac Pontiac Michigan
United States Saint Joseph Mercy Oakland Pontiac Michigan
United States Southern Ohio Medical Center Portsmouth Ohio
United States Geisinger Cancer Services-Pottsville Pottsville Pennsylvania
United States Harrison HealthPartners Hematology and Oncology-Poulsbo Poulsbo Washington
United States Cancer Center of Kansas - Pratt Pratt Kansas
United States Utah Valley Regional Medical Center Provo Utah
United States MultiCare Good Samaritan Hospital Puyallup Washington
United States Aurora Cancer Care-Racine Racine Wisconsin
United States Kaiser Permanente-Redwood City Redwood City California
United States Spectrum Health Reed City Hospital Reed City Michigan
United States Beebe Health Campus Rehoboth Beach Delaware
United States Annie Penn Memorial Hospital Reidsville North Carolina
United States Marshfield Medical Center-Rice Lake Rice Lake Wisconsin
United States Kaiser Permanente-Richmond Richmond California
United States Kaiser Permanente-Riverside Riverside California
United States North Memorial Medical Health Center Robbinsdale Minnesota
United States Great Lakes Cancer Management Specialists-Rochester Hills Rochester Hills Michigan
United States Kaiser Permanente-Roseville Roseville California
United States Kaiser Permanente - Sacramento Sacramento California
United States Kaiser Permanente Downtown Commons Sacramento California
United States Kaiser Permanente-South Sacramento Sacramento California
United States Ascension Saint Mary's Hospital Saginaw Michigan
United States Lakeland Medical Center Saint Joseph Saint Joseph Michigan
United States Marie Yeager Cancer Center Saint Joseph Michigan
United States Mercy Hospital Saint Louis Saint Louis Missouri
United States Missouri Baptist Medical Center Saint Louis Missouri
United States Saint Louis Cancer and Breast Institute-South City Saint Louis Missouri
United States Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota
United States Regions Hospital Saint Paul Minnesota
United States United Hospital Saint Paul Minnesota
United States Cancer Center of Kansas - Salina Salina Kansas
United States Kaiser Permanente-San Diego Zion San Diego California
United States Kaiser Permanente-San Francisco San Francisco California
United States Kaiser Permanente-Santa Teresa-San Jose San Jose California
United States Kaiser Permanente San Leandro San Leandro California
United States Kaiser Permanente-San Marcos San Marcos California
United States Kaiser Permanente-San Rafael San Rafael California
United States Kaiser San Rafael-Gallinas San Rafael California
United States Kaiser Permanente Medical Center - Santa Clara Santa Clara California
United States Kaiser Permanente-Santa Rosa Santa Rosa California
United States Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah Georgia
United States Community Medical Center Scranton Pennsylvania
United States TidalHealth Nanticoke / Allen Cancer Center Seaford Delaware
United States Geisinger Medical Oncology-Selinsgrove Selinsgrove Pennsylvania
United States Prisma Health Cancer Institute - Seneca Seneca South Carolina
United States Saint Francis Regional Medical Center Shakopee Minnesota
United States HSHS Saint Nicholas Hospital Sheboygan Wisconsin
United States Vince Lombardi Cancer Clinic-Sheboygan Sheboygan Wisconsin
United States Willis-Knighton Medical and Cancer Center Shreveport Louisiana
United States Siouxland Regional Cancer Center Sioux City Iowa
United States Sanford Cancer Center Oncology Clinic Sioux Falls South Dakota
United States Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota
United States Kaiser Permanente-South San Francisco South San Francisco California
United States Spartanburg Medical Center Spartanburg South Carolina
United States CoxHealth South Hospital Springfield Missouri
United States Mercy Hospital Springfield Springfield Missouri
United States Springfield Regional Cancer Center Springfield Ohio
United States Springfield Regional Medical Center Springfield Ohio
United States Geisinger Medical Group State College Pennsylvania
United States Marshfield Clinic Stevens Point Center Stevens Point Wisconsin
United States Lakeview Hospital Stillwater Minnesota
United States Kaiser Permanente-Stockton Stockton California
United States Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay Wisconsin
United States Aurora Medical Center in Summit Summit Wisconsin
United States MultiCare Tacoma General Hospital Tacoma Washington
United States National Jewish Health-Northern Hematology Oncology Thornton Colorado
United States Munson Medical Center Traverse City Michigan
United States Dayton Physicians LLC-Upper Valley Troy Ohio
United States Upper Valley Medical Center Troy Ohio
United States Vince Lombardi Cancer Clinic-Two Rivers Two Rivers Wisconsin
United States MGC Hematology Oncology-Union Union South Carolina
United States Carle Cancer Center Urbana Illinois
United States Kaiser Permanente Medical Center-Vacaville Vacaville California
United States Kaiser Permanente-Vallejo Vallejo California
United States Essentia Health Virginia Clinic Virginia Minnesota
United States Ridgeview Medical Center Waconia Minnesota
United States Kaiser Permanente-Walnut Creek Walnut Creek California
United States Great Lakes Cancer Management Specialists-Macomb Professional Building Warren Michigan
United States Macomb Hematology Oncology PC Warren Michigan
United States Saint John Macomb-Oakland Hospital Warren Michigan
United States Marshfield Clinic-Wausau Center Wausau Wisconsin
United States Aurora Cancer Care-Milwaukee West Wauwatosa Wisconsin
United States Cancer Center of Kansas - Wellington Wellington Kansas
United States Aurora West Allis Medical Center West Allis Wisconsin
United States Methodist West Hospital West Des Moines Iowa
United States Saint Ann's Hospital Westerville Ohio
United States Marshfield Medical Center - Weston Weston Wisconsin
United States SCL Health Lutheran Medical Center Wheat Ridge Colorado
United States Ascension Via Christi Hospitals Wichita Wichita Kansas
United States Associates In Womens Health Wichita Kansas
United States Cancer Center of Kansas - Wichita Wichita Kansas
United States Cancer Center of Kansas-Wichita Medical Arts Tower Wichita Kansas
United States Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre Pennsylvania
United States Rice Memorial Hospital Willmar Minnesota
United States Cancer Center of Kansas - Winfield Winfield Kansas
United States Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids Wisconsin
United States Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota
United States Kaiser Permanente-Woodland Hills Woodland Hills California
United States Lankenau Medical Center Wynnewood Pennsylvania
United States Fairview Lakes Medical Center Wyoming Minnesota
United States Metro Health Hospital Wyoming Michigan
United States IHA Hematology Oncology Consultants-Ann Arbor Ypsilanti Michigan
United States Genesis Healthcare System Cancer Care Center Zanesville Ohio

Sponsors (2)

Lead Sponsor Collaborator
NRG Oncology National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change From Baseline at 9 Weeks in the Desire Subscore of the Female Sexual Function Index ("Sexual Desire") The desire subscore of the female sexual function index (FSFI) measures self-reported sexual desire. Possible scores range from 1.2 to 6, with higher scores indicating increased desire. Change score is calculated by subtracting baseline from later score, with a positive change score indicating increased desire. This measure is referred to as "sexual desire" in the protocol. Baseline (prior to randomization) and 9 weeks from start of study treatment (within 21 days of randomization)
Secondary Change From Baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Score The PROMIS fatigue score measures self-reported fatigue symptoms over the past 7 days. Possible scores range from 33.1 to 77.8, with higher scores indicating more fatigue. Change score is calculated by subtracting baseline from later score, with a positive change score indicating increased fatigue. Baseline (prior to randomization) and 5 and 9 weeks from start of study treatment (within 21 days of randomization)
Secondary Change From Baseline at 5 Weeks in Desire Subscore of the FSFI ("Sexual Desire") The desire subscore of the female sexual function index (FSFI) measures self-reported sexual desire. Possible scores range from 1.2 to 6, with higher scores indicating increased desire. Change score is calculated by subtracting baseline from later score, with a positive change score indicating increased desire. This measure is referred to as "sexual desire" in the protocol. Baseline (prior to randomization) and 5 weeks from start of study treatment (within 21 days of randomization)
Secondary Change From Baseline in the PROMIS Global Satisfaction With Sex Life Subscore of Sexual Function and Satisfaction Measure ("Sexual Desire and Satisfaction") The PROMIS Global Satisfaction with Sex Life subscore measures self-reported global satisfaction, interest, and interference in sexual health over the past 7 days. Possible scores range from 3 to 30, with higher scores indicating more satisfaction with sex life. Change score is calculated by subtracting baseline from later score, with a positive change score indicating increased satisfaction. This score is referred to as the "PROMIS sexual desire and satisfaction measure" in the protocol. Baseline (prior to randomization) and 5 and 9 weeks from start of study treatment (within 21 days of randomization)
Secondary Change From Baseline in FSFI Total Score ("Sexual Functioning") The FSFI total score measures self-reported female sexual functioning covering the major domains arousal, satisfaction, and orgasm, and including lubrication and pain. Possible scores range from 2 to 36, with higher scores indicating better functioning. Change score is calculated by subtracting baseline from later score, with a positive change score indicating increased functioning. This measure is referred to as "sexual functioning" in the protocol. Baseline (prior to randomization) and 5 and 9 weeks from start of treatment (within 21 days of randomization)
Secondary Change From Baseline in the Patient Health Questionnaire (PHQ)-4 Score ("Depressive Mood") The PHQ-4 is a brief screening questionnaire for depression. Possible scores range from 0 to 12, with higher scores indicating more severe depression. Change score is calculated by subtracting baseline from later score, with a negative change score indicating decreased severity of depression. This measure is referred to as "depressive mood" in the protocol. Baseline (prior to randomization) and 5 and 9 weeks from start of treatment (within 21 days of randomization)
Secondary Global Impression of Change at 9 Weeks ("Perception of Change") Participants are asked, "Since beginning the study agent, my desire of sexual intimacy is:" with seven possible answers of "very much better," "moderately better," "a little better," "about the same," "a little worse," "moderately worse," and "very much worse." The first three answers have been categorized as "Better' and the last three answers as "Not Better". This measure is referred to as "perception of change" in the protocol. 9 weeks from start of study treatment (within 21 days of randomization)
Secondary Perception of Risk vs. Benefit at 9 Weeks Participants are asked, "Were the benefits of this treatment greater than any side effects?" 9 weeks from start of study treatment (within 21 days of randomization)
Secondary Number of Participants With a Grade 3 or Higher Adverse Event Over the Course of the Study Common Terminology Criteria for Adverse Events (version 4) grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure.; see Adverse Events Module for specific adverse event data. Adverse events were evaluated 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).
Secondary Number of Participants With Most Severe Response for Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) at 9 Weeks Questions refer to the participants' experiences for the past 7 days of a given symptom in terms of frequency (never, rarely, occasionally, frequently, almost constantly), severity (none, mild, moderate, severe, very severe), interference with usual or daily activities (not at all, a little bit, somewhat, quite a bit, very much). 9 weeks from start of study treatment (within 21 days of randomization).
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