Trial of Exercise and Lifestyle for Women With Ovarian and Endometrial Cancer
ConditionOvarian Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorYale University
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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%
Trial design
Treatments tested in this trial
- Exercise and medical nutrition
Treatment groups
200 Participants
are divided into 2 treatment groupsSponsors and collaborators
Yale University
Lead sponsor
University of Miami
Collaborator
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov