Ovarian Cancer Clinical Trial
Trial of Exercise and Lifestyle in Women With Ovarian Cancer
Summary
An anticipated 200 women with newly diagnosed ovarian 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.
Full Description
200 women with newly diagnosed OC scheduled to receive chemotherapy (adjuvant chemotherapy after surgery or neoadjuvant chemotherapy before surgery) will be recruited from Smilow Cancer Hospital at Yale Cancer Center (YCC) and Sylvester Comprehensive Cancer Center (SCCC) at University of Miami. If women are interested and eligible, the study team will obtain consent and collect baseline data. Participants will be randomized to an 18-week exercise and medical nutrition intervention or attention control throughout therapy. After the standard 6 cycles of chemotherapy (~18 weeks), a post-chemotherapy/end of intervention visit will be conducted. Follow-up assessments will be at standard of care visits (3-months post-chemotherapy and 12-months post-diagnosis). Data required to calculate the primary endpoint (relative dose intensity of chemotherapy) will be abstracted from the medical record directly following each chemotherapy session.
Eligibility Criteria
Inclusion Criteria:
have a diagnosis of epithelial ovarian cancer, fallopian tube or primary peritoneal carcinoma, stage I-IV
be scheduled to receive 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 (>5 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)
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