S0927: Omega-3-Fatty Acid Supplements in Treating Muscle and Bone Pain and Stiffness in Pts W/Stage I, II, or III Breast Cancer Receiving Hormone Therapy

Breast Cancer Clinical Trial

Official title:

S0927: A Randomized Placebo-Controlled Trial of Omega-3-Fatty Acid for the Control of Aromatase Inhibitor-Induced Musculoskeletal Pain and Stiffness In Women With Early Stage Breast Cancer, Phase III

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01385137
• Other study ID #: S0927
• Secondary ID: S0927U10CA037429
• Status: Completed
• Phase: Phase 3
• First received: June 28, 2011
• Last updated: October 15, 2015
• Start date: February 2012
• Est. completion date: March 2014

Study information

• Verified date: October 2015
• Source: Southwest Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: An omega-3 fatty acid-enriched nutritional supplement may help improve muscle and bone pain and stiffness caused by hormone therapy in patients with breast cancer.

PURPOSE: This randomized phase III trial is studying omega-3 fatty acid supplements in treating muscle and bone pain and stiffness in patients with stage I, stage II, or stage III breast cancer receiving hormone therapy.

Description:

OBJECTIVES:

Primary

• To assess whether omega-3-fatty acid as compared to placebo causes a reduction in worst joint pain and/or stiffness at 12 weeks, as measured by the modified Brief Pain Inventory (BPI), in women with early-stage breast cancer and aromatase inhibitor (AI)-associated arthralgia.

Secondary

• To assess the proportion of patients who report improved versus deteriorated joint pain with omega-3-fatty acid versus placebo.

• To assess the proportion of patients who report improved versus deteriorated joint stiffness with omega-3-fatty acid versus placebo.

• To assess whether patients receiving omega-3-fatty acid compared to placebo have decreased analgesic use and increased AI adherence.

• To assess whether patients receiving omega-3-fatty acid compared to placebo have improved functioning, pain, and stiffness in the knees/hips (as measured by the Western Ontario and McMaster Universities Osteoarthritis, WOMAC) score.

• To assess whether patients receiving omega-3-fatty acid have improved functioning, pain, and stiffness in the hands (as measured by the Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands, M-SACRAH).

• To assess whether patients receiving omega-3-fatty acid compared to placebo have improved functional quality of life as measured by the Functional Assessment of Cancer Therapy-Endocrine Subscale (FACT-ES) Trial Outcome Index (TOI).

• To assess whether patients receiving omega-3-fatty acid report changes for the better versus worse compared to placebo as measured by the Global Rating of Change Scale.

• To identify minimally important change in the WOMAC, M-SACRAH, and the FACT-ES Trial Outcome Index (TOI) using "a little better" or "a little worse" responses on the patient-reported global rating of change in joint pain and joint stiffness.

• To assess whether patients receiving omega-3-fatty acid compared to placebo have an improved lipid profile as measured by triglycerides, HDL, and LDL.

• To assess the toxicity of omega-3-fatty acid compared to placebo in this setting.

• To assess whether there is a difference in serum-free and total estradiol levels before and after treatment with omega-3-fatty acid compared to placebo.

• To explore whether CYP19A1 genotype correlates with severity of joint symptoms or predicts response to omega-3-fatty acid. (exploratory)

• To explore changes in hormonal and inflammatory serum biomarkers, such as IL6, TNF-α, and CRP.

• To assess whether there is a relationship between change in serum docosahexaenoic acid (DHA) and EPA and resolution of joint symptoms.

• To establish a cohort of patients (placebo group) to better characterize the natural history of the syndrome.

OUTLINE: This is a multicenter study. Patients are stratified according to prior osteoarthritis (yes vs no) and prior taxane use (yes vs no). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity.

• Arm II: Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity.

Patients undergo blood sample collection at baseline and at 12 and 24 weeks for biomarker and DNA analysis.

Patients complete the Brief Pain Inventory Short Form (BPI-SF), the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index, the Modified-Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands (M-SACRAH), the FACT-ES Trial Outcome Index, and the Omega-3-fatty acid Dietary Intake questionnaires at baseline and at 6, 12, and 24 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 262
• Est. completion date: March 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 120 Years

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed primary invasive adenocarcinoma of the breast

• Stage I, II, or IIIA disease

• No metastatic disease

• Must have undergone modified radical mastectomy or breast-sparing surgery and recovered

• Estrogen-receptor positive (ER+) and/or progesterone-receptor positive (PR+)

• Currently taking a third-generation aromatase inhibitor (AI) [e.g., anastrozole (Arimidex®), letrozole (Femara®), or exemestane (Aromasin®)] for = 90 days prior to registration with plans to continue for = 180 days after registration

• Must have completed the S092 Brief Pain Inventory (BPI)-Short Form within the past 14 days, and must have a worst pain/stiffness of = 5 on the BPI (item #2) that has started or increased with AI therapy

PATIENT CHARACTERISTICS:

• Postmenopausal

• Zubrod performance status 0-2

• Willing to submit blood for serum-free estradiol, total estradiol, serum inflammatory markers (IL6, TNF-a, CRP), DHA and EPA, lipid profile (LDL, HDL, triglycerides), and DNA analysis (CYP19A1)

• Able to complete study questionnaires in English

• At least 5 years since other malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, ductal carcinoma in situ of the breast or adequately treated stage I or II cancer from which the patient is currently in complete remission

• Patients must not have a known allergy to soy, given that the placebo is suspended in soybean oil

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• At least 3 months since prior omega-3 fatty acid supplements and must agree to refrain from omega-3-fatty acid supplements from sources outside of this study

• More than 28 days since prior investigational agents

• No other medical therapy, alternative therapy, or physical therapy for joint pain/stiffness within the past 30 days

• Patients must not be on anticoagulation medication (i.e., heparin/warfarin) because of increased risk of bleeding within 28 days prior to registration

• Patients must not have a history of bone fracture or surgery of the afflicted knees and/or hands within 6 months prior to registration

• Patients must not be on narcotics within 14 days of registration

• Patients may have received corticosteroid treatment; however, the following criteria apply:

• Patients must not have received oral or intramuscular corticosteroids within the 28 days prior to registration

• Patients must not have received intra-articular steroids to the study, or any other, joint within 28 days prior to registration

• Patients must not have received topical analgesics (e.g., capsaicin preparations) to the study joint or any other analgesics (e.g., opiates, tramadol; with the exception of nonsteroidal antiinflammatory drugs (NSAIDs) and acetaminophen) within 14 days prior to registration

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Arthralgia
• Breast Cancer
• Breast Neoplasms
• Pain

Intervention

Dietary Supplement:
• omega-3 fatty acid
Given orally

Other:
• placebo
Given orally

Locations

Country	Name	City	State
United States	McDowell Cancer Center at Akron General Medical Center	Akron	Ohio
United States	Lovelace Medical Center - Downtown	Albuquerque	New Mexico
United States	University of New Mexico Cancer Center	Albuquerque	New Mexico
United States	CHRISTUS Cabrini Cancer Center	Alexandria	Louisiana
United States	American Fork Hospital	American Fork	Utah
United States	Island Hospital Cancer Care Center at Island Hospital	Anacortes	Washington
United States	Kaiser Permanente Medical Center - Anaheim/Orange County	Anaheim	California
United States	Alaska Regional Hospital Cancer Center	Anchorage	Alaska
United States	AnMed Cancer Center	Anderson	South Carolina
United States	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan
United States	Saint Joseph Mercy Cancer Center	Ann Arbor	Michigan
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	Kaiser Permanente - Deer Valley	Antioch	California
United States	Randolph Hospital	Asheboro	North Carolina
United States	Mission Hospitals - Memorial Campus	Asheville	North Carolina
United States	Kaiser Permanente Medical Center - Baldwin Park	Baldwin Park	California
United States	Alvin and Lois Lapidus Cancer Institute at Sinai Hospital	Baltimore	Maryland
United States	Battle Creek Health System Cancer Care Center	Battle Creek	Michigan
United States	Bay Regional Medical Center	Bay City	Michigan
United States	St. Francis Hospital and Health Centers - Beech Grove Campus	Beech Grove	Indiana
United States	Kaiser Permanente Medical Center - Bellflower	Bellflower	California
United States	St. Joseph Cancer Center	Bellingham	Washington
United States	St. Charles Medical Center - Bend	Bend	Oregon
United States	Alta Bates Summit Comprehensive Cancer Center	Berkeley	California
United States	Mecosta County Medical Center	Big Rapids	Michigan
United States	Billings Clinic - Downtown	Billings	Montana
United States	CCOP - Montana Cancer Consortium	Billings	Montana
United States	Hematology-Oncology Centers of the Northern Rockies - Billings	Billings	Montana
United States	St. Vincent Healthcare Cancer Care Services	Billings	Montana
United States	Mountain States Tumor Institute at St. Luke's Regional Medical Center	Boise	Idaho
United States	Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center	Boise	Idaho
United States	Central Care Cancer Center at Carrie J. Babb Cancer Center	Bolivar	Missouri
United States	Bozeman Deaconess Cancer Center	Bozeman	Montana
United States	Olympic Hematology and Oncology	Bremerton	Washington
United States	Highline Medical Center Cancer Center	Burien	Washington
United States	Peninsula Medical Center	Burlingame	California
United States	Lahey Clinic Medical Center - Burlington	Burlington	Massachusetts
United States	Saint Francis Medical Center	Cape Girardeau	Missouri
United States	Rocky Mountain Oncology	Casper	Wyoming
United States	Sandra L. Maxwell Cancer Center	Cedar City	Utah
United States	Providence Centralia Hospital	Centralia	Washington
United States	Cancer Center of Kansas, PA - Chanute	Chanute	Kansas
United States	Presbyterian Cancer Center at Presbyterian Hospital	Charlotte	North Carolina
United States	Adena Regional Medical Center	Chillicothe	Ohio
United States	Clackamas Radiation Oncology Center	Clackamas	Oregon
United States	CCOP - Columbus	Columbus	Ohio
United States	Doctors Hospital at Ohio Health	Columbus	Ohio
United States	Grant Medical Center Cancer Care	Columbus	Ohio
United States	Mount Carmel Health - West Hospital	Columbus	Ohio
United States	Riverside Methodist Hospital Cancer Care	Columbus	Ohio
United States	Baylor University Medical Center - Dallas	Dallas	Texas
United States	Danville Regional Medical Center	Danville	Virginia
United States	Genesis Regional Cancer Center at Genesis Medical Center	Davenport	Iowa
United States	CCOP - Dayton	Dayton	Ohio
United States	David L. Rike Cancer Center at Miami Valley Hospital	Dayton	Ohio
United States	Good Samaritan Hospital	Dayton	Ohio
United States	Grandview Hospital	Dayton	Ohio
United States	Samaritan North Cancer Care Center	Dayton	Ohio
United States	Oakwood Cancer Center at Oakwood Hospital and Medical Center	Dearborn	Michigan
United States	Decatur Memorial Hospital Cancer Care Institute	Decatur	Illinois
United States	Grady Memorial Hospital	Delaware	Ohio
United States	Kaiser Permanente - Denver	Denver	Colorado
United States	Josephine Ford Cancer Center at Henry Ford Hospital	Detroit	Michigan
United States	Cancer Center of Kansas, PA - Dodge City	Dodge City	Kansas
United States	Falck Cancer Center at Arnot Ogden Medical Center	Elmira	New York
United States	Providence Regional Cancer Partnership	Everett	Washington
United States	Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital	Fairbanks	Alaska
United States	St. Francis Hospital	Federal Way	Washington
United States	Blanchard Valley Medical Associates	Findlay	Ohio
United States	Genesys Hurley Cancer Institute	Flint	Michigan
United States	Hurley Medical Center	Flint	Michigan
United States	McLaren Cancer Institute	Flint	Michigan
United States	Singh and Arora Hematology Oncology, PC	Flint	Michigan
United States	McLeod Regional Medical Center	Florence	South Carolina
United States	Kaiser Permanente Medical Center - Fontana	Fontana	California
United States	Front Range Cancer Specialists	Fort Collins	Colorado
United States	Poudre Valley Hospital	Fort Collins	Colorado
United States	Broward General Medical Center Cancer Center	Fort Lauderdale	Florida
United States	Cancer Center of Kansas - Fort Scott	Fort Scott	Kansas
United States	Middletown Regional Hospital	Franklin	Ohio
United States	Kaiser Permanente - Fremont	Fremont	California
United States	Kaiser Permanente Fresno Medical Center	Fresno	California
United States	Saint Luke's Mountain States Tumor Institute - Fruitland	Fruitland	Idaho
United States	Northeast Georgia Medical Center	Gainesville	Georgia
United States	CaroMont Cancer Center at Gaston Memorial Hospital	Gastonia	North Carolina
United States	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina
United States	Butterworth Hospital at Spectrum Health	Grand Rapids	Michigan
United States	CCOP - Grand Rapids	Grand Rapids	Michigan
United States	Lacks Cancer Center at Saint Mary's Health Care	Grand Rapids	Michigan
United States	Sletten Cancer Institute at Benefis Healthcare	Great Falls	Montana
United States	Moses Cone Regional Cancer Center at Wesley Long Community Hospital	Greensboro	North Carolina
United States	Bon Secours St. Francis Health System	Greenville	South Carolina
United States	Cancer Centers of the Carolinas - Faris Road	Greenville	South Carolina
United States	Cancer Centers of the Carolinas - Grove Commons	Greenville	South Carolina
United States	CCOP - Greenville	Greenville	South Carolina
United States	Wayne Hospital	Greenville	Ohio
United States	Self Regional Cancer Center at Self Regional Medical Center	Greenwood	South Carolina
United States	Cancer Centers of the Carolinas - Greer Medical Oncology	Greer	South Carolina
United States	Legacy Mount Hood Medical Center	Gresham	Oregon
United States	Van Elslander Cancer Center at St. John Hospital and Medical Center	Grosse Pointe Woods	Michigan
United States	Kaiser Permanente Medical Center - Harbor City	Harbor City	California
United States	Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center	Hartford	Connecticut
United States	Kaiser Permanente Medical Center - Hayward	Hayward	California
United States	St. Peter's Hospital	Helena	Montana
United States	Pardee Memorial Hospital	Hendersonville	North Carolina
United States	Kaiser Permanente - Moanalua Medical Center and Clinic	Honolulu	Hawaii
United States	Methodist Hospital	Houston	Texas
United States	Cancer Center of Kansas-Independence	Independence	Kansas
United States	Kaiser Permanente - Irvine	Irvine	California
United States	Baylor Medical Center at Irving	Irving	Texas
United States	Swedish Medical Center - Issaquah Campus	Issaquah	Washington
United States	Foote Memorial Hospital	Jackson	Michigan
United States	University of Mississippi Cancer Clinic	Jackson	Mississippi
United States	Kalispell Regional Medical Center	Kalispell	Montana
United States	Heartland Hematology Oncology Associates, Incorporated	Kansas City	Missouri
United States	North Kansas City Hospital	Kansas City	Missouri
United States	Research Medical Center	Kansas City	Missouri
United States	Saint Luke's Cancer Institute at Saint Luke's Hospital	Kansas City	Missouri
United States	Good Samaritan Cancer Center at Good Samaritan Hospital	Kearney	Nebraska
United States	Columbia Basin Hematology	Kennewick	Washington
United States	Charles F. Kettering Memorial Hospital	Kettering	Ohio
United States	Cancer Center of Kansas, PA - Kingman	Kingman	Kansas
United States	Cascade Cancer Center at Evergreen Hospital Medical Center	Kirkland	Washington
United States	Thompson Cancer Survival Center	Knoxville	Tennessee
United States	Carolina Blood and Cancer Care Associates, PA	Lancaster	South Carolina
United States	Fairfield Medical Center	Lancaster	Ohio
United States	Sparrow Regional Cancer Center	Lansing	Michigan
United States	Great Lakes Cancer Institute - Lapeer Campus	Lapeer	Michigan
United States	Lawrence Memorial Hospital	Lawrence	Kansas
United States	Saint Luke's East - Lee's Summit	Lee's Summit	Missouri
United States	St. Joseph Regional Medical Center	Lewiston	Idaho
United States	Central Baptist Hospital	Lexington	Kentucky
United States	Cancer Center of Kansas, PA - Liberal	Liberal	Kansas
United States	Parvin Radiation Oncology	Liberty	Missouri
United States	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	St. Mary Mercy Hospital	Livonia	Michigan
United States	Logan Regional Hospital	Logan	Utah
United States	Kaiser Foundation Hospital - West Los Angeles	Los Angeles	California
United States	Kaiser Permanente Medical Center - Los Angeles	Los Angeles	California
United States	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California
United States	Strecker Cancer Center at Marietta Memorial Hospital	Marietta	Ohio
United States	Contra Costa Regional Medical Center	Martinez	California
United States	Tibotec Therapeutics - Division of Ortho Biotech Products, LP	Marysville	California
United States	Cardinal Bernardin Cancer Center at Loyola University Medical Center	Maywood	Illinois
United States	Mercy Cancer Center at Mercy Medical Center	Merced	California
United States	Mountain States Tumor Institute - Meridian	Meridian	Idaho
United States	Tucker Center for Cancer Care at Orange Regional Medical Center	Middletown	New York
United States	Providence Milwaukie Hospital	Milwaukie	Oregon
United States	Winthrop University Hospital	Mineola	New York
United States	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Missoula	Montana
United States	Montana Cancer Specialists at Montana Cancer Center	Missoula	Montana
United States	Providence Cancer Center at Providence Hospital	Mobile	Alabama
United States	Louisiana State University Health Sciences Center - Monroe	Monroe	Louisiana
United States	Clemens Regional Medical Center	Mount Clemens	Michigan
United States	Good Samaritan Regional Health Center	Mount Vernon	Illinois
United States	Knox Community Hospital	Mount Vernon	Ohio
United States	Skagit Valley Hospital Cancer Care Center	Mount Vernon	Washington
United States	El Camino Hospital Cancer Center	Mountain View	California
United States	Jon and Karen Huntsman Cancer Center at Intermountain Medical Center	Murray	Utah
United States	Mercy General Health Partners	Muskegon	Michigan
United States	Saint Luke's Mountain States Tumor Institute	Nampa	Idaho
United States	Edward Hospital Cancer Center	Naperville	Illinois
United States	Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center	New York	New York
United States	Licking Memorial Cancer Care Program at Licking Memorial Hospital	Newark	Ohio
United States	Providence Newberg Medical Center	Newberg	Oregon
United States	Cancer Center of Kansas, PA - Newton	Newton	Kansas
United States	Sutter Health - Western Division Cancer Research Group	Novato	California
United States	Alta Bates Summit Medical Center - Summit Campus	Oakland	California
United States	CCOP - Bay Area Tumor Institute	Oakland	California
United States	Epic Care - Oakland	Oakland	California
United States	Highland General Hospital	Oakland	California
United States	Kaiser Permanente Medical Center - Oakland	Oakland	California
United States	Val and Ann Browning Cancer Center at McKay-Dee Hospital Center	Ogden	Utah
United States	Providence St. Peter Hospital Regional Cancer Center	Olympia	Washington
United States	Willamette Falls Hospital	Oregon City	Oregon
United States	Menorah Medical Center	Overland Park	Kansas
United States	Saint Luke's Hospital - South	Overland Park	Kansas
United States	Kaiser Permanente Medical Group	Panorama City	California
United States	Cancer Center of Kansas, PA - Parsons	Parsons	Kansas
United States	Regional Cancer Center at Singing River Hospital	Pascagoula	Mississippi
United States	Northern Michigan Hospital	Petoskey	Michigan
United States	Valley Medical Oncology Consultants - Pleasanton	Pleasanton	California
United States	St. Joseph Mercy Oakland	Pontiac	Michigan
United States	Mercy Regional Cancer Center at Mercy Hospital	Port Huron	Michigan
United States	CCOP - Columbia River Oncology Program	Portland	Oregon
United States	Legacy Emanuel Hospital and Health Center and Children's Hospital	Portland	Oregon
United States	Legacy Good Samaritan Hospital & Comprehensive Cancer Center	Portland	Oregon
United States	Providence Cancer Center at Providence Portland Medical Center	Portland	Oregon
United States	Providence St. Vincent Medical Center	Portland	Oregon
United States	Southern Ohio Medical Center Cancer Center	Portsmouth	Ohio
United States	Harrison Poulsbo Hematology and Onocology	Poulsbo	Washington
United States	CCOP - Kansas City	Prairie Village	Kansas
United States	Cancer Center of Kansas, PA - Pratt	Pratt	Kansas
United States	Utah Valley Regional Medical Center - Provo	Provo	Utah
United States	Good Samaritan Cancer Center	Puyallup	Washington
United States	Kaiser Permanente Medical Center - Redwood City	Redwood City	California
United States	Spectrum Health Reed City Hospital	Reed City	Michigan
United States	Kaiser Permanente Medical Center - Richmond	Richmond	California
United States	Reid Hospital & Health Care Services	Richmond	Indiana
United States	Kaiser Permanente Medical Center - Riverside	Riverside	California
United States	Highland Hospital of Rochester	Rochester	New York
United States	James P. Wilmot Cancer Center at University of Rochester Medical Center	Rochester	New York
United States	Carolina Blood and Cancer Care	Rock Hill	South Carolina
United States	Highlands Oncology Group - Springdale	Rogers	Arkansas
United States	Phelps County Regional Medical Center	Rolla	Missouri
United States	Kaiser Permanente Medical Center - Roseville	Roseville	California
United States	Sutter Cancer Center at Roseville Medical Center	Roseville	California
United States	Kaiser Permanente Medical Center - Sacramento	Sacramento	California
United States	South Sacramento Kaiser-Permanente Medical Center	Sacramento	California
United States	Sutter Cancer Center	Sacramento	California
United States	University of California Davis Cancer Center	Sacramento	California
United States	Seton Cancer Institute at Saint Mary's - Saginaw	Saginaw	Michigan
United States	Dixie Regional Medical Center - East Campus	Saint George	Utah
United States	Heartland Regional Medical Center	Saint Joseph	Missouri
United States	CCOP - St. Louis-Cape Girardeau	Saint Louis	Missouri
United States	David C. Pratt Cancer Center at St. John's Mercy	Saint Louis	Missouri
United States	Midwest Hematology Oncology Group, Incorporated	Saint Louis	Missouri
United States	Salem Hospital Regional Cancer Care Services	Salem	Oregon
United States	Cancer Center of Kansas, PA - Salina	Salina	Kansas
United States	Huntsman Cancer Institute at University of Utah	Salt Lake City	Utah
United States	LDS Hospital	Salt Lake City	Utah
United States	Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San Diego	San Diego	California
United States	Kaiser Permanente Medical Office -Vandever Medical Office	San Diego	California
United States	California Pacific Medical Center - California Campus	San Francisco	California
United States	Kaiser Permanente Medical Center - San Francisco Geary Campus	San Francisco	California
United States	Kaiser Permanente Medical Center - Santa Teresa	San Jose	California
United States	Kaiser Permanente Health Care	San Marcos	California
United States	Doctors Medical Center - San Pablo Campus	San Pablo	California
United States	Kaiser Foundation Hospital - San Rafael	San Rafael	California
United States	Kaiser Permanente Medical Center - Santa Clara Kiely Campus	Santa Clara	California
United States	Kaiser Permanente Medical Center - Santa Rosa	Santa Rosa	California
United States	Sutter Pacific Medical Foundation	Santa Rosa	California
United States	Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center	Savannah	Georgia
United States	CCOP - Virginia Mason Research Center	Seattle	Washington
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington
United States	Group Health Central Hospital	Seattle	Washington
United States	Harborview Medical Center	Seattle	Washington
United States	Minor and James Medical, PLLC	Seattle	Washington
United States	Pacific Medical Center	Seattle	Washington
United States	Polyclinic First Hill	Seattle	Washington
United States	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus	Seattle	Washington
United States	University Cancer Center at University of Washington Medical Center	Seattle	Washington
United States	North Puget Oncology at United General Hospital	Sedro-Woolley	Washington
United States	Cancer Centers of the Carolinas - Seneca	Seneca	South Carolina
United States	Feist-Weiller Cancer Center at Louisiana State University Health Sciences	Shreveport	Louisiana
United States	Highland Clinic	Shreveport	Louisiana
United States	Kaiser Permanente Medical Center - South San Francisco	South San Francisco	California
United States	Providence Cancer Institute at Providence Hospital - Southfield Campus	Southfield	Michigan
United States	Cancer Centers of the Carolinas - Spartanburg	Spartanburg	South Carolina
United States	CCOP - Upstate Carolina	Spartanburg	South Carolina
United States	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center	Spartanburg	South Carolina
United States	Cancer Care Northwest - Spokane South	Spokane	Washington
United States	Evergreen Hematology and Oncology, PS	Spokane	Washington
United States	CCOP - Cancer Research for the Ozarks	Springfield	Missouri
United States	Community Hospital of Springfield and Clark County	Springfield	Ohio
United States	Hulston Cancer Center at Cox Medical Center South	Springfield	Missouri
United States	Regional Cancer Center at Memorial Medical Center	Springfield	Illinois
United States	St. John's Regional Health Center	Springfield	Missouri
United States	Iredell Memorial Hospital	Statesville	North Carolina
United States	Kaiser Permanente Medical Facility - Stockton	Stockton	California
United States	Allenmore Hospital	Tacoma	Washington
United States	CCOP - Northwest	Tacoma	Washington
United States	Franciscan Cancer Center at St. Joseph Medical Center	Tacoma	Washington
United States	MultiCare Regional Cancer Center at Tacoma General Hospital	Tacoma	Washington
United States	St. Clare Hospital	Tacoma	Washington
United States	Cotton-O'Neil Cancer Center	Topeka	Kansas
United States	Munson Medical Center	Traverse City	Michigan
United States	UVMC Cancer Care Center at Upper Valley Medical Center	Troy	Ohio
United States	Tahoe Forest Cancer Center	Truckee	California
United States	Legacy Meridian Park Hospital	Tualatin	Oregon
United States	Mountain States Tumor Institute at St. Luke's	Twin Falls	Idaho
United States	Kaiser Permanente Medical Center - Vacaville	Vacaville	California
United States	Kaiser Permanente Medical Center - Vallejo	Vallejo	California
United States	Sutter Solano Medical Center	Vallejo	California
United States	Legacy Salmon Creek Medical Center	Vancouver	Washington
United States	Southwest Washington Medical Center Cancer Center	Vancouver	Washington
United States	Kaiser Permanente Medical Center - Walnut Creek	Walnut Creek	California
United States	St. John Macomb Hospital	Warren	Michigan
United States	Cancer Center of Kansas, PA - Wellington	Wellington	Kansas
United States	Wenatchee Valley Medical Center	Wenatchee	Washington
United States	Mount Carmel St. Ann's Cancer Center	Westerville	Ohio
United States	Associates in Womens Health, PA - North Review	Wichita	Kansas
United States	Cancer Center of Kansas, PA - Medical Arts Tower	Wichita	Kansas
United States	Cancer Center of Kansas, PA - Wichita	Wichita	Kansas
United States	CCOP - Wichita	Wichita	Kansas
United States	Via Christi Cancer Center at Via Christi Regional Medical Center	Wichita	Kansas
United States	Cancer Center of Kansas, PA - Winfield	Winfield	Kansas
United States	Kaiser Permanente Medical Cener - Woodland Hills	Woodland Hills	California
United States	United States Air Force Medical Center - Wright-Patterson	Wright-Patterson Afb	Ohio
United States	Ruth G. McMillan Cancer Center at Greene Memorial Hospital	Xenia	Ohio
United States	North Star Lodge Cancer Center at Yakima Valley Memorial Hospital	Yakima	Washington
United States	Genesis - Good Samaritan Hospital	Zanesville	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Southwest Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in worst joint pain and/or stiffness		12 weeks	No
Secondary	Proportion of joint pain and stiffness improvement versus deterioration with omega-3-fatty acid versus placebo		6, 12, and 24 weeks	No
Secondary	Adverse events as assessed by NCI CTCAE vs 4.0		6, 12, and 24 weeks	Yes
Secondary	Frequency of new pain medications used		6, 12, and 24 weeks	No
Secondary	Changes in serum-free and total estradiol levels as measured by liquid chromatography and mass spectrometry		2 years from study activation	No
Secondary	Changes in hormonal and inflammatory serum biomarkers		2 years from study activation	No
Secondary	Changes in fasting cholesterol levels		2 years from study activation	No