Exercise and Lifestyle for Ovarian and Endometrial Cancer

This study is looking at whether exercise and good nutrition can help women with newly diagnosed ovarian or endometrial cancer who are receiving chemotherapy. You could join if you are a woman aged 18 or older with epithelial ovarian, fallopian tube, primary peritoneal, or advanced/metastatic endometrial cancer, and your treatment includes carboplatin and taxane (or similar drugs) for at least 6 cycles. Participants will be split into two groups: one receiving weekly counseling on exercise and nutrition, and another receiving usual care. The main goal is to see if these lifestyle changes help you complete your chemotherapy treatment as planned. This study is currently recruiting 200 women at Yale Cancer Center and Sylvester Comprehensive Cancer Center.

Study design
This is an interventional study with 200 participants. You would be randomly assigned to either an exercise and medical nutrition group or a control group.
What's involved
If you join, you would have weekly counseling sessions via phone or Zoom for about 18 weeks during your chemotherapy. Assessments will be done at the beginning, after chemotherapy, and one year after diagnosis.
Compensation
Not stated in the trial record.
Follow-up
You will have follow-up assessments at standard of care visits, 12 months after your diagnosis.

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NCT05761561

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

Recruiting
NAAges 18+InterventionalSupportive care
Yale University
~200 participants
Updated 2026-07-20 on ClinicalTrials.gov
What's tested:Exercise and medical nutrition

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Chemotherapy completion rate (relative dose intensity)
Measured over Through end of first line chemotherapy, an average of 5 months
Ovarian Cancer
2 sites across 2 states
Connecticut1
Florida1

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Eligibility criteria

Inclusion

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

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
  • Chemotherapy completion rate (relative dose intensity)Through end of first line chemotherapy, an average of 5 months

    Chemotherapy completion rate will be assessed as the average relative dose intensity for the originally planned regimen based on standard formulas. This will be measured using the number and percent of patients requiring dose-adjustments, dose-delays, reason for dose.