RECRUITINGINTERVENTIONAL

Trial of Exercise and Lifestyle for Women With Ovarian and Endometrial Cancer

Trial of Exercise and Lifestyle (TEAL) for Women With Ovarian and Endometrial Cancer

About This Trial

An anticipated 200 women with newly diagnosed ovarian and endometrial cancer scheduled to receive chemotherapy (adjuvant chemotherapy after surgery or neoadjuvant chemotherapy before surgery) will be recruited from Smilow Cancer Hospital Network at Yale Cancer Center (YCC) and Sylvester Comprehensive Cancer Center (SCCC) at University of Miami. Participants will be randomized to an exercise and medical nutrition intervention arm with weekly counseling sessions throughout chemotherapy, or a control arm. Study assessments will be conducted at baseline, post-chemotherapy/end of intervention and at 1-year post diagnosis. Women who are prescribed neoadjuvant therapy will have additional assessments prior to surgery. Data required to calculate the primary endpoint (relative dose intensity of chemotherapy) will be abstracted from the medical record directly following each chemotherapy session.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 - pregnancy or intention to become pregnant - recent (past year) stroke/myocardial infarction or congestive heart failure/ejection fraction \<40% - presence of dementia or major psychiatric disease - in active treatment including target or biologic therapies for any other cancer (excluding hormone therapy treatments) - receiving external beam radiation Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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 * pregnancy or intention to become pregnant * recent (past year) stroke/myocardial infarction or congestive heart failure/ejection fraction \<40% * presence of dementia or major psychiatric disease * in active treatment including target or biologic therapies for any other cancer (excluding hormone therapy treatments) * receiving external beam radiation

Treatments Being Tested

BEHAVIORAL

Exercise and medical nutrition

The study dietitian and exercise trainer will each conduct weekly counseling sessions via telephone or zoom throughout the course of chemotherapy (approximately 18 weeks) to assist the participants in achieving the diet and exercise study goals. Participants will be provided written informational material, exercise bands for strength training and a Fitbit to record activity. Participant goals are to: 1) participate in 150 min/week of moderate-intensity physical activity 2) participate in two weekly strength training sessions; 3) eat a combination of 5 or more servings of vegetables and/or fruits per day 4) consume 25 grams or more of fiber/day; 5) consume adequate amounts of protein to prevent muscle wasting (1.2g/kg body weight).

Locations (2)

Yale University

New Haven, Connecticut, United States

University of Miami

Miami, Florida, United States