The Effects of Moderate Exercise on Distress, Quality of Life, and Biomarkers of Angiogenesis and Chronic Stress in Ovarian Cancer Survivors
Histologically or cytologically confirmed stage II-IV epithelial ovarian, fallopian tube, or peritoneal cancer. 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, or adenocarcinoma not otherwise specified. If site of origin cannot be specified, carcinoma of Mullerian origin may be included if most consistent with ovarian/fallopian tube/primary peritoneal origin rather than uterine origin. 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 (
Subjects must have completed surgery and adjuvant chemotherapy for treatment of ovarian 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.
Ability to understand and the willingness to sign a written informed consent document.
Women participating in 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.
Other eligibility criteria may apply.
Subjects who have had surgery, chemotherapy and/or radiation therapy within 4 weeks prior to screening.
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, third degree heart block, uncontrolled hypertension (systolic > 200, diastolic > 100), conditions (cardiovascular, respiratory, or musculoskeletal disease or joint problems) that preclude moderate physical activity. Subjects with a history of cardiac arrest or stroke, or those with moderate/severe aortic 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. Women 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.
Other exclusion criteria may apply.