Ovarian CancerNCT03641287
The Effects of Exercise on Distress, Quality of Life, and Biomarkers in Ovarian Cancer Survivors
A study testing Exercise Counseling, Aerobic Exercise and Physiological Support in people with Ovarian Cancer and Fallopian Tube Adenocarcinoma, run by University of Washington at 1 site in United States.
Trial summary
Many individuals with ovarian cancer experience distress, fatigue, weakness, anxiety, and other symptoms that decrease quality of life. Moderate exercise may improve quality of life, decrease distress, and improve biomarkers associated with prognosis in individuals with ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Fallopian Tube Adenocarcinoma, Fallopian Tube Carcinosarcoma
- What is being tested?
- Exercise Counseling, Aerobic Exercise and Physiological Support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2018to 30 Sep 2022
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed stage II-IV epithelial ovarian, fallopian tube, or peritoneal cancer. If site of origin cannot be specified, carcinoma of Mullerian origin may be included if most consistent with ovarian/fallopian tube/peritoneal origin rather than uterine origin. The following histologic epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, clear cell carcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's tumor, undifferentiated carcinoma, carcinosarcoma, or adenocarcinoma not otherwise specified. Women with neoplasms of low malignant potential (borderline tumors) are not eligible.
- Subjects must have no evidence of disease, as defined by their treating oncologist, and with normal CA-125 (=< 35).
- Subjects must have completed primary surgery and adjuvant chemotherapy for treatment of ovarian, fallopian tube, of peritoneal cancer within one to six months of screening. Maintenance therapy will be allowed as long as the participant is in clinical remission- including hormonal agents, anti-angiogenesis agents, PARP inhibitors, and immunotherapy. Prior radiation therapy is allowed, as long as it has been completed within one to six months of screening. Subjects may have received prior therapies (including surgery, chemotherapy, radiation therapy) for other malignancies in the past.
- Eastern Cooperative Oncology Group (ECOG) status of 0, 1, or 2.
- Pregnancy and the need for contraception:
- Participants with ovarian cancer have undergone hysterectomy with removal of ovaries and tubes as part of surgical treatment, and therefore do not have the potential to become pregnant.
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- Ambulatory.
- Ability to understand and the willingness to sign a written informed consent document.
- Individuals participating in most other clinical trials are eligible provided their enrollment in the other trial does not impair their ability to participate in the physical activity interventions and study assessments required in this trial. The other clinical trial must not be a behavioral intervention trial.
Who cannot join
- Subjects who have had primary surgery, chemotherapy and/or radiation therapy within 4 weeks prior to screening. Subjects may have received other surgeries not performed for primary treatment (for example, removal of intraperitoneal port, laparoscopic cholecystectomy, etc.) within 1 month of screening as long as they do not have post-operative restrictions that would preclude participating in a moderate intensity exercise program once enrolled in the clinical trial.
- Self-reported inability to walk at least 2 blocks (at any pace).
- Prior brain metastasis is not an exclusion, as long as subject is in clinical remission.
- Uncontrolled or concurrent illness including, but not limited to: unstable angina pectoris, recent (within six months) myocardial infarction, uncontrolled cardiac arrhythmia, uncontrolled congestive heart failure, hypertrophic obstructive cardiomyopathy, uncontrolled hypertension (systolic > 200, diastolic > 120), conditions (cardiovascular, respiratory, or musculoskeletal disease or joint problems) that preclude moderate physical activity. Subjects with a history of cardiac arrest, or those with moderate/severe aortic or mitral stenosis may be eligible if their treating physician determines that moderate physical activity is safe. Moderate arthritis that does not preclude physical activity is not a reason for ineligibility. Individuals with lymphedema or peripheral neuropathy will not be excluded. They will be evaluated by the exercise physiologist for safety and modifications to the exercise prescription will be made as appropriate.
- Psychiatric illness/social situations that would limit compliance with study requirements.
- Already physically active > 90 minutes per week of moderate exercise.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: The Effects of Moderate Exercise on Distress, Quality of Life, and Biomarkers of Angiogenesis and Chronic Stress in Ovarian Cancer Survivors - A Randomized Controlled Trial
Many individuals with ovarian cancer experience distress, fatigue, weakness, anxiety, and other symptoms that decrease quality of life. Moderate exercise may improve quality of life, decrease distress, and improve biomarkers associated with prognosis in individuals with ovarian cancer. This clinical trial studies how well moderate exercise works in improving distress, quality of life, and biomarkers of angiogenesis and chronic stress in individuals with ovarian, fallopian tube, and primary peritoneal cancer.
Read the detailed description
OUTLINE:
Patients are randomized to 1 of 2 arms.
ARM I (EXERCISE INTERVENTION): Patients meet with exercise physiologist for 1, 60 minute session. Patients then receive individualized exercise prescription with goal of moderate aerobic exercise over 150 minutes per week at home for up to 24 weeks. Patients also receive telephone-based motivational support by exercise physiologist weekly for 24 weeks.
ARM II (CONTROL GROUP): Patients maintain habitual levels of physical activity and receive general education material about ovarian cancer and survivorship for 24 weeks. After 24 weeks, patients are offered exercise intervention.
- Conditions
- Ovarian Cancer, Fallopian Tube Adenocarcinoma, Fallopian Tube Carcinosarcoma, Fallopian Tube Clear Cell Adenocarcinoma, Fallopian Tube Endometrioid Adenocarcinoma, Fallopian Tube Mucinous Adenocarcinoma
- Being tested
- Exercise Counseling, Aerobic Exercise, Physiological Support, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Ovarian Neoplasms, Brenner Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise CounselingOther
Meet with exercise physiology
Aerobic ExerciseOther
Also called Aerobic Activity, aerobic exercise
Receive prescription for moderate aerobic exercise
Physiological SupportOther
Receive motivational support via telephone care
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Best PracticeOther
Also called best practice, standard of care, standard of care, standard therapy
Undergo habitual level of physical activity
| Study group | Role | What they receive |
|---|---|---|
| Arm I (aerobic exercise) | Experimental | Participants meet with exercise physiologist for 1, 60 minute session. Participants then receive individualized exercise prescription with goal of moderate aerobic exercise over 150 minutes per week at home for up to 24 weeks. Participants also receive telephone-based motivational support by exercise physiologist weekly for 24 weeks. Receives: Other: Exercise Counseling; Other: Aerobic Exercise; Other: Physiological Support; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
| Arm II (habitual level of physical activity) | Active comparator | Participants maintain habitual levels of physical activity and receive general education material about ovarian cancer and survivorship for 24 weeks. After 24 weeks, participants are offered exercise intervention. Receives: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Best Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of Life Measured Using the RAND 36-item Short Form Health Survey Physical Component Score
Will be measured using the RAND 36-item Short Form Health Survey Physical Component Score. Mean change from baseline to 24 weeks between the exercise intervention and control group in the RAND 36-item Short Form Health Survey Physical Component Score.
RAND 36-Item Short Form assesses eight subscales including physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, general health perceptions, and perceived change in health. Possible scores for each subscale range from 0 to 100. The Physical Component Score (PCS) is an aggregate of the eight subscales using a standardized algorithm, with a mean of 50 and standard deviation of 10 in the general US population. Possible scores range from 20 to 60, with higher scores indicating a better quality of life.
Measured: Baseline up to 24 weeks
Change in Distress, Measured Using the Perceived Stress Scale
Will be measured using the Perceived Stress Scale. Mean change from baseline to 24 weeks between the exercise intervention and control group in the Perceived Stress Scale.
The Perceived Stress Scale is a 10 item questionnaire with a total score range of 0-40. Higher total scores indicate higher distress.
Measured: Baseline to 24 weeks
Change in Distress, Measured Using the Hospital Anxiety and Depression Scale - Anxiety Subscale
Will be measured using the Hospital Anxiety and Depression Scale - Anxiety subscale. Mean change from baseline to 24 weeks between the exercise intervention and control group in the Hospital Anxiety and Depression Scale - anxiety subscale.
The Hospital Anxiety and Depression Scale includes 2 subscales: anxiety and depression.
The Hospital Anxiety and Depression Scale - anxiety subscale total scores range from 0 to 21; higher scores indicated greater severity of anxiety symptoms.
Measured: Baseline to 24 weeks
Change in Distress, Measured Using the Hospital Anxiety and Depression Scale - Depression Subscale
Will be measured using the Hospital Anxiety and Depression Scale - Depression sub scale. Mean change from baseline to 24 weeks between the exercise intervention and control group in the Hospital Anxiety and Depression Scale - Depression subscale.
The Hospital Anxiety and Depression Scale includes 2 subscales: anxiety and depression.
The Hospital Anxiety and Depression Scale - Depression subscale total scores range from 0 to 21; higher scores indicated greater severity of depression symptoms.
Measured: Baseline to 24 weeks
Change in IL-6 (Biomarker of Angiogenesis)
Mean change from baseline to 24 weeks between the exercise intervention and control group in mean levels of IL-6.
Measured: Baseline to 24 weeks
Change in VEGF (Biomarker of Angiogenesis)
Mean change from baseline to 24 weeks between the exercise intervention and control group in mean levels of VEGF.
Measured: Baseline to 24 weeks
Change in Nocturnal Cortisol (Biomarker of Chronic Stress)
Mean change from baseline to 24 weeks between the exercise intervention and control group in mean level of evening salivary cortisol.
Measured: Baseline to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start5 Dec 2018
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Why it stopped: Enrollment ended early due to the funding timeline
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Kathryn Pennington, University of Washington
- Investigators
- Kathryn Pennington, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03641287
- Sponsor's protocol ID
- RG1001826
- Other IDs
- 10045, NCI-2018-01630, R21CA215662
- Status last verified
- Nov 2023
- First submitted
- 15 Aug 2018
- Last updated
- 29 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No