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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00993928
Other study ID # NCCTG-N07C4
Secondary ID NCI-2011-01978CD
Status Terminated
Phase Phase 2
First received
Last updated
Start date April 2010
Est. completion date May 1, 2019

Study information

Verified date November 2019
Source Alliance for Clinical Trials in Oncology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

RATIONALE: Following a program that uses written materials and pre-recorded mp3 devices may help improve the sleep of cancer survivors. It is not yet known which home-based program is more effective in improving the sleep of cancer survivors.

PURPOSE: This randomized phase II trial is comparing two home-based programs for improving sleep in cancer survivors.


Description:

OBJECTIVES:

Primary

- To compare the efficacy of two home-based sleep interventions as therapy for sleep-wake disturbances,as measured by sleep latency or time to fall back asleep after initial sleep onset per sleep diaries, at baseline (week 1) and at the end of week 7 in cancer survivors.

Secondary

- To compare the efficacy of these interventions as therapy for sleep-wake disturbances as measured by the number of awakenings after sleep, sleep quality, sleep difficulty, and sleep latency at baseline (week 1) and weeks 4 and 7 in these participants.

- To compare the efficacy of these interventions as therapy for sleep-wake disturbances as measured by the percentage of participants in each group who show improved sleep per the Pittsburgh Sleep Quality Index.

- To compare the effects of these interventions on fatigue, mood disturbance, sleep, benefit, and distress in this patient population.

- To describe the side effects associated with these interventions in these patients.

- To describe patient practice habits and adherence measured via a sleep behavior record.

- To explore symptom clusters in this patient population and look at distress as a mediating variable. (Exploratory)

- To explore predictors of sleep quality. (Exploratory)

OUTLINE: This is a multicenter study. Patients are stratified according to current (≥ 1 per week in the past 4 weeks) pharmacological treatment, including anxiolytics, for insomnia or mood (yes vs no), current pharmacologic treatment for pain (yes vs no), sleep difficulty period (≤ 1 month vs > 1 month), and age (≤ 50 vs 51-70 vs > 70 years). Patients are randomized to 1 of 2 intervention groups.

- Group 1: Participants receive a home-based sleep intervention comprising a Sleep Hygiene Education booklet, printed stimulus-control guidelines, instructions on sleeping restrictions, and a guided-imagery pre-recorded mp3 device. Participants meet with study personnel for intervention refinement and are asked to practice behaviors consistent with the stimulus-control sheet, to read the sleep hygiene booklet one chapter per day for 7 days during the first week, and then as needed during study. They are also instructed to use the CD, with or without headphones, in a quiet and comfortable place without lights for up to 30 minutes every day for 6 weeks before bedtime. Participants are instructed to go to sleep and wake at the same time every day during study intervention.

- Group 2: Participants receive a home-based sleep intervention comprising a Sleep Hygiene Education booklet, printed stimulus-control guidelines, and a pre-recorded mp3 device containing short stories and essays. Participants meet with study personnel and are instructed to practice behaviors consistent with the stimulus control sheet, to read the sleep hygiene booklet, and use the CD as in group 1. Participants are not instructed about sleeping restrictions. They are offered the guided-imagery CD after study completion.

Patients complete a Three-Day Sleep Behavior Record for 3 consecutive days at baseline and during weeks 4 and 7 of study intervention. Patients also complete questionnaires on Numeric Analog Sleep for Pain Scale, daily use of CD, Sleep Hygiene Practice, Pittsburgh Sleep Quality Index, Profile of Mood States, Brief Fatigue Inventory, Distress Thermometer, Side-Effect Questionnaire, and a Subject Global Impression of Change at baseline, during weeks 2 and 6, and after completion of study intervention.


Recruitment information / eligibility

Status Terminated
Enrollment 93
Est. completion date May 1, 2019
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility DISEASE CHARACTERISTICS:

- Prior diagnosis of cancer

- At least 2 months and = 24 months since completed curative-intent treatment (chemotherapy, surgery, and/or radiotherapy)

- Ongoing hormonal therapy (i.e., tamoxifen, aromatase inhibitors, casodex)

- Concurrent trastuzumab and maintenance rituximab allowed

- Sleep difficulty defined as self report of sleep latency of = 30 minutes on 3 out of 7 nights in a week and wishing therapeutic intervention, and/or self report of waking up after first falling asleep and not being able to fall back asleep for = 30 minutes on 3 out of 7 nights in a week

- No history of diagnosis of primary insomnia (patient medical record, defined by having had behavioral, cognitive, or pharmacologic treatment) for > 30 consecutive days in the year before cancer diagnosis

- No active cancer (i.e., not considered no evidence of disease)

- No concurrent CNS malignancy

- No history of diagnosed sleep disorder (i.e., obstructive sleep apnea, restless legs, or periodic leg movement disorder)

PATIENT CHARACTERISTICS:

- ECOG performance status 0-1

- Availability of a CD player and head or earphones

- Ability to complete questionnaires

- No uncontrolled chronic pain (i.e., pain score of = 4 on Numeric Analogue Sleep and Pain Scale)

- No diagnosis of major depression disorder, acute anxiety disorder, or schizophrenia per medical record

- No hot flashes that interrupt sleep

- Not working overnight hours and unable to change schedule

- No emotional, psychological, or physical state that, according to physician and/or study personnel evaluation, would preclude adherence to daily home intervention implementation

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- More than 4 days since prior corticosteroid, including inhaled steroids, of any dose for > 2 days

- No prior experience with guided imagery or cognitive behavioral therapy for insomnia

- No concurrent new herbal therapies

- Stable dose of daily herbal supplements started = 8 weeks before study intervention allowed

- Herbal teas or herbs in various drink products allowed

- No concurrent treatment with variable doses of any of the following:

- Antidepressants

- Anxiolytics

- Pain medication (not including over the counter ad anti-inflammatory pain relievers)

- Pharmacologic treatment for sleep/wake disturbances is allowed, but must be used for 4 weeks before study entry, and can be used daily or intermittently

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Home-based sleep intervention
Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet.

Locations

Country Name City State
United States Oncare Hawaii, Incorporated - Pali Momi 'Aiea Hawaii
United States Pali Momi Medical Center 'Aiea Hawaii
United States Bixby Medical Center Adrian Michigan
United States Toledo Clinic Cancer Centers - Adrian Adrian Michigan
United States Phoebe Putney Memorial Hospital Albany Georgia
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 Ochsner Clinic Foundation-Baton Rouge Baton Rouge Louisiana
United States St. Francis Hospital and Health Centers - Beech Grove Campus Beech Grove Indiana
United States Billings Clinic Billings Montana
United States Frontier Cancer Center and Blood Institutes - Billings Billings Montana
United States Montana Cancer Consortium CCOP Billings Montana
United States Saint Vincent Healthcare Billings Montana
United States Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center Boise Idaho
United States Saint Alphonsus Regional Medical Center Boise Idaho
United States Central Care Cancer Center-Carrie J Babb Cancer Center Bolivar Missouri
United States Toledo Clinic Cancer Centers - Bowling Green Bowling Green Ohio
United States Bozeman Deaconess Cancer Center Bozeman Montana
United States Roswell Park Cancer Institute Buffalo New York
United States Saint James Community Hospital and Cancer Treatment Center Butte Montana
United States Southeast Cancer Center Cape Girardeau Missouri
United States Cedar Rapids Oncology Associates Cedar Rapids Iowa
United States Mercy Hospital Cedar Rapids Iowa
United States Mercy Regional Cancer Center at Mercy Medical Center Cedar Rapids Iowa
United States Cancer Center of Kansas, PA - Chanute Chanute Kansas
United States Weiss Memorial Hospital Chicago Illinois
United States Adena Regional Medical Center Chillicothe Ohio
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 Geisinger Cancer Institute at Geisinger Health Danville Pennsylvania
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 Grady Memorial Hospital Delaware Ohio
United States Saint John Hospital and Medical Center Detroit Michigan
United States Cancer Center of Kansas, PA - Dodge City Dodge City Kansas
United States CCOP - Duluth Duluth Minnesota
United States Essentia Health - Duluth Clinic Duluth Minnesota
United States Miller - Dwan Medical Center Duluth Minnesota
United States Hematology Oncology Associates of Central New York PC East Syracuse New York
United States Marshfield Clinic Cancer Care at Regional Cancer Center Eau Claire Wisconsin
United States Cancer Center of Kansas, PA - El Dorado El Dorado Kansas
United States Elkhart Clinic, LLC Elkhart Indiana
United States Elkhart General Hospital Elkhart Indiana
United States Michiana Hematology-Oncology, PC - Elkhart Elkhart Indiana
United States Community Health Partners Regional Medical Center - Mercy Cancer Center Elyria Ohio
United States Hematology Oncology Center Incorporated Elyria Ohio
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 Cancer Center of Kansas - Fort Scott Fort Scott Kansas
United States Middletown Regional Hospital Franklin Ohio
United States Fredericksburg Oncology Inc. Fredericksburg Virginia
United States Adams Cancer Center Gettysburg Pennsylvania
United States Wayne Memorial Hospital, Incorporated Goldsboro North Carolina
United States Benefis Healthcare - Sletten Cancer Institute Great Falls Montana
United States Cancer Centers of the Carolinas - Faris Road Greenville South Carolina
United States Greenville Cancer Center of the Carolinas (CCOP) Greenville South Carolina
United States Wayne Hospital Greenville Ohio
United States Cancer Centers of the Carolinas-Greer Medical Oncology Greer South Carolina
United States Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods Michigan
United States Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center Hartford Connecticut
United States Geisinger Hazleton Cancer Center Hazleton Pennsylvania
United States Saint Peter's Community Hospital Helena Montana
United States Margaret R Pardee Memorial Hospital Hendersonville North Carolina
United States Kapiolani Medical Center for Women and Children Honolulu Hawaii
United States Oncare Hawaii Inc-POB II Honolulu Hawaii
United States OnCare Hawaii, Incorporated - Kuakini Honolulu Hawaii
United States Queen's Medical Center Honolulu Hawaii
United States Straub Clinic and Hospital, Incorporated Honolulu Hawaii
United States University of Hawaii Honolulu Hawaii
United States Cancer Center of Kansas-Independence Independence Kansas
United States University of Iowa Hospitals and Clinics Iowa City Iowa
United States Allegiance Health Jackson Michigan
United States Foote Memorial Hospital Jackson Michigan
United States Capital Region Medical Center-Goldschmidt Cancer Center Jefferson City Missouri
United States Castle Medical Center Kailua Hawaii
United States Kalispell Regional Medical Center Kalispell Montana
United States Charles F. Kettering Memorial Hospital Kettering Ohio
United States Cancer Center of Kansas, PA - Kingman Kingman Kansas
United States Community Howard Regional Health Kokomo Indiana
United States Howard Community Hospital Kokomo Indiana
United States Gundersen Lutheran Health System/CCOP La Crosse Wisconsin
United States Center for Cancer Therapy at LaPorte Hospital and Health Services La Porte Indiana
United States Lakeland Regional Cancer Center at Lakeland Regional Medical Center Lakeland Florida
United States Fairfield Medical Center Lancaster Ohio
United States Sparrow Regional Cancer Center Lansing Michigan
United States Nevada Cancer Research Foundation CCOP Las Vegas Nevada
United States University Medical Center of Southern Nevada Las Vegas Nevada
United States Lawrence Memorial Hospital Lawrence Kansas
United States Cancer Center of Kansas, PA - Liberal Liberal Kansas
United States Cancer Center of Kansas-Liberal Liberal Kansas
United States Wilcox Memorial Hospital and Kauai Medical Clinic Lihue Hawaii
United States Lima Memorial Hospital Lima Ohio
United States St. Mary Mercy Hospital Livonia Michigan
United States Immanuel St. Joseph's Mankato Minnesota
United States Mayo Clinic Health Systems-Mankato Mankato Minnesota
United States Strecker Cancer Center at Marietta Memorial Hospital Marietta Ohio
United States Marshfield Clinic - Marshfield Center Marshfield Wisconsin
United States Mercy Cancer Center at Mercy Medical Center - North Iowa Mason City Iowa
United States Toledo Radiation Oncology at Northwest Ohio Oncology Center Maumee Ohio
United States Marshfield Clinic - Lakeland Center Minocqua Wisconsin
United States Marshfield Clinic-Minocqua Center Minocqua Wisconsin
United States Michiana Hematology-Oncology, PC - South Bend Mishawaka Indiana
United States Saint Joseph Regional Medical Center Mishawaka Indiana
United States Montana Cancer Specialists Missoula Montana
United States Saint Patrick Hospital - Community Hospital Missoula Montana
United States Mercy Memorial Hospital - Monroe Monroe Michigan
United States Toledo Clinic Cancer Centers - Monroe Monroe Michigan
United States Knox Community Hospital Mount Vernon Ohio
United States Saint Joseph Hospital Nashua New Hampshire
United States Ochsner Baptist Medical Center New Orleans Louisiana
United States Ochsner Cancer Institute at Ochsner Clinic Foundation New Orleans Louisiana
United States Licking Memorial Cancer Care Program at Licking Memorial Hospital Newark Ohio
United States Cancer Center of Kansas, PA - Newton Newton Kansas
United States Saint Charles Hospital Oregon Ohio
United States Toledo Clinic Cancer Centers - Oregon Oregon Ohio
United States Florida Hospital - Orlando Orlando Florida
United States Cancer Center of Kansas, PA - Parsons Parsons Kansas
United States Michiana Hematology Oncology PC - Plymouth Plymouth Indiana
United States St. Joseph Mercy Oakland Pontiac Michigan
United States Mercy Regional Cancer Center at Mercy Hospital Port Huron Michigan
United States Southern Ohio Medical Center Cancer Center Portsmouth Ohio
United States Cancer Center of Kansas, PA - Pratt Pratt Kansas
United States Marshfield Clinic at James Beck Cancer Center Rhinelander Wisconsin
United States Ministry Medical Group at Saint Mary's Hospital Rhinelander Wisconsin
United States Marshfield Clinic - Indianhead Center Rice Lake Wisconsin
United States Marshfield Clinic-Rice Lake Center Rice Lake Wisconsin
United States Reid Hospital & Health Care Services Richmond Indiana
United States Mayo Clinic Cancer Center Rochester Minnesota
United States Mercy Clinic-Rolla-Cancer and Hematology Rolla Missouri
United States Rutherford Hospital Rutherfordton North Carolina
United States Seton Cancer Institute at Saint Mary's - Saginaw Saginaw Michigan
United States CentraCare Clinic - River Campus Saint Cloud Minnesota
United States Coborn Cancer Center Saint Cloud Minnesota
United States Saint Cloud Hospital Saint Cloud Minnesota
United States Lakeland Regional Cancer Care Center - St. Joseph Saint Joseph Michigan
United States Lakeside Cancer Specialists, PLLC Saint Joseph Michigan
United States Marie Yeager Cancer Center Saint Joseph Michigan
United States Missouri Baptist Cancer Center Saint Louis Missouri
United States Cancer Center of Kansas, PA - Salina Salina Kansas
United States Mayo Clinic Scottsdale Scottsdale Arizona
United States Mercy Medical Center - Sioux City Sioux City Iowa
United States Siouxland Hematology-Oncology Associates, LLP Sioux City Iowa
United States St. Luke's Regional Medical Center Sioux City Iowa
United States Avera Cancer Institute Sioux Falls South Dakota
United States CCOP - Northern Indiana CR Consortium South Bend Indiana
United States Memorial Hospital of South Bend South Bend Indiana
United States Michiana Hematology Oncology PC-South Bend South Bend Indiana
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 CCOP - Cancer Research for the Ozarks Springfield Missouri
United States Community Hospital of Springfield and Clark County Springfield Ohio
United States Cox Medical Center Springfield Missouri
United States Hulston Cancer Center at Cox Medical Center South Springfield Missouri
United States Mercy-Springfield Springfield Missouri
United States Ozark Health Ventures LLC dba Cancer Research for the Ozarks - Springfield Springfield Missouri
United States St. John's Regional Health Center Springfield Missouri
United States Geisinger Medical Group - Scenery Park State College Pennsylvania
United States Marshfield Clinic at Saint Michael's Hospital Stevens Point Wisconsin
United States Flower Hospital Sylvania Ohio
United States Mercy Hospital of Tiffin Tiffin Ohio
United States Mercy Cancer Center - Saint Anne Mercy Hospital Toledo Ohio
United States Saint Vincent Mercy Medical Center Toledo Ohio
United States The Toledo Hospital/Toledo Children's Hospital Toledo Ohio
United States University of Toledo Toledo Ohio
United States UVMC Cancer Care Center at Upper Valley Medical Center Troy Ohio
United States Natalie Warren Bryant Cancer Center at St. Francis Hospital Tulsa Oklahoma
United States St. John Macomb Hospital Warren Michigan
United States Fulton County Health Center Wauseon Ohio
United States Cancer Center of Kansas, PA - Wellington Wellington Kansas
United States Mount Carmel St. Ann's Cancer Center Westerville Ohio
United States Marshfield Clinic - Weston Center Weston Wisconsin
United States Michiana Hematology Oncology PC - La Porte Westville Indiana
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 Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center Wilkes-Barre Pennsylvania
United States Cancer Center of Kansas, PA - Winfield Winfield Kansas
United States Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids Wisconsin
United States Ruth G. McMillan Cancer Center at Greene Memorial Hospital Xenia Ohio
United States WellSpan Health-York Hospital York Pennsylvania
United States Genesis - Good Samaritan Hospital Zanesville Ohio

Sponsors (2)

Lead Sponsor Collaborator
Alliance for Clinical Trials in Oncology National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change of the (3 Day) Sleep Latency Time and Time to Fall Back Asleep After Awakening During the Night From Baseline to the End of Study at Week 7 The primary analysis will compare the change in time (in minutes) to fall asleep from baseline to week 7 as reported by question 3 in the sleep diary: "How long did it take you to get to sleep last night?" and time to fall back asleep after awakening during the night as reported by question 6A on sleep dairy: "When waking up after first falling asleep, how long did it take you to fall back to sleep?" >
> Data were analyzed as a percent change from baseline to week 7. The percent change were compared between arms using a Wilcoxon rank-sum test.
Baseline and 7 weeks
Secondary Efficacy of Home-based Interventions on the Number of Awakenings After Sleep, Sleep Quality, Sleep Difficulty, and Sleep Latency at Baseline and Weeks 4 and 7. Overall efficacy was analyzed as a composite of 4 outcomes: 1. sleep difficulty, 2. sleep quality, 3. Number of awakenings, and 4. Sleep latency. These 4 outcomes were measured by the responses to the following questions, respectively:
How difficult was it to get to sleep last night? (scale 1-5, 5 meaning very easy)
>
How deeply did you sleep last night? (scale 1-5, 5 meaning very deeply)
>
How many times did you awaken last night?
>
How long did it take you to get to sleep last night?
>
> The 4 questions were analyzed as percent change from baseline after week 4 and after week 7. The percent change between arms was analyzed using a Wilcoxon test.
Baseline and 7 weeks
Secondary Comparing the Efficacy of Two Home-based Sleep Interventions as Therapy for Sleep-wake Disturbances as Measured by the Percent of People Who Show Improved Sleep Per the Pittsburgh Sleep Quality Index (PSQI) The PSQI has 19 items and seven component scales: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep-wake disturbances, use of sleep medication, and daytime dysfunction. The scoring algorithm yields seven component scales on 0-3 scales which are summed to produce a global score on a 0-21 scale with higher values representing more severe sleep difficulty. The percentage of patients that showed improvement or worsening in sleep score from baseline to Week 7 were analyzed and compared using a Chi-squared test. Baseline and 7 weeks
Secondary Total Mood Disturbance as Measured by Profiles of Mood States B (POMS-B) The POMS-B is a shortened version of the original POMS with 30 items each asking the patient to select how he/she has been feeling during the past week with respect to an adjective such as "tense", "angry", "worn out", etc., on a 0-4 scale (0=not at all; 4=extremely). The POMS-B consists of six identifiable mood states (tension/anxiety, depression/dejection, anger/hostility, vigor/activity, fatigue/inertia, and confusion/bewilderment) and measures the patient's total mood disturbance. This study analyzed total mood disturbance (total scale score) as a secondary endpoints. Possible weekly scores ranged from 0-120. Week 7 scores were analyzed as a percentage change from baseline with a negative score representing a worsening condition. A Wilcoxon rank-sum test was used to compare treatment arms. At baseline and week 7
Secondary Distress at Week 6 The Distress Thermometer is a single-item tool which asks patients to describe how much distress he/she has been experiencing in the past week on a scale of 0 to 10 (0=no distress, 10=extreme distress). The Distress Thermometer was selected for this study due to its brevity. Week 7 distress measures were analyzed as percent change from baseline and analyzed between arms with a t-test. From baseline to week 7
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