An official website of the United States government
Exercise and Lifestyle for Women with Ovarian Cancer and Endometrial Cancer, TEAL Study
Trial Status: active
This clinical trial tests examines exercise and lifestyle for women with ovarian and endometrial cancer. Side effects from chemotherapy are very common, occurring in two-thirds of ovarian cancer patients, and can often delay or reduce chemotherapy treatment. A delay or reduction in chemotherapy can have a major impact on how effective treatment will be. Participating in a guided nutrition and exercise program during chemotherapy may reduce side effects from the treatment.
Inclusion Criteria
Have a diagnosis of epithelial ovarian cancer, fallopian tube or primary peritoneal carcinoma, stage I-IV, OR have a diagnosis of advanced or metastatic endometrial carcinoma (including carcinosarcoma) AND their treatment regimen includes carboplatin and taxane (or equivalent)
Be scheduled to receive at least 6 cycles of neoadjuvant or adjuvant chemotherapy
Be physically able to walk without a walking aid (e.g. cane or walker)
Be able to complete forms, understand instructions and read intervention book in English or Spanish
Agree to be randomly assigned to either group
Have clearance from oncologist to participate
Be ≥ 18 years of age
Exclusion Criteria
Having already completed a 2nd cycle of chemotherapy
Already practicing dietary (> 7 servings of fruits and vegetables per day) OR physical activity guidelines (≥ 150 min per week of moderate to vigorous exercise) and resistance training two times per week since diagnosis
I. To assess the effect of the intervention on relative dose intensity (RDI), an integrated measure of chemotherapy dose delays and reductions.
II. To assess the effect of the intervention on patient-reported chemotoxicities including neuropathy, cognitive function, depression, fatigue, arthralgia, and gastrointestinal disorders.
III. To assess changes in body composition and muscle mass assessed via computed tomography (CT) scans and urinary D3‐creatine dilution method.
IV. To assess the longer-term effect of the intervention on physical activity, diet, body composition, patient-reported chemotoxicities, and health care utilization.
V. Exploratory analyses will be conducted that may include genomic analyses.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo home-based exercise intervention consisting of walking and strength training and eating a healthy diet over 2.5 hours per week for 18 weeks. Patients also receive nutrition and exercise counselling over 18 weeks. After completing chemotherapy, patients receive 4 booster counselling sessions every other week for the 2 months. Patients also receive TEAL intervention workbook and Fitbit activity tracker. Patients also undergo CT scan on study.
ARM II: Patients receive weekly telephone calls during 18 week chemotherapy treatment. At the end of the study, patients then receive TEAL intervention workbook, Fitbit activity tracker, and a counselling session. Patients also undergo CT scan on study.
After completion of study, patients are followed up at 12 months.
