Exercise and nutrition program for women with ovarian and endometrial cancer
Trial of Exercise and Lifestyle (TEAL) for Women With Ovarian and Endometrial Cancer
This study is testing whether an exercise and nutrition program can help women with ovarian or endometrial cancer feel better during chemotherapy compared to those receiving regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Yale University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (New Haven, Connecticut and 1 other locations) |
| Trial ID | NCT05761561 on ClinicalTrials.gov |
What this trial studies
This study aims to recruit 200 women diagnosed with ovarian or endometrial cancer who are scheduled to undergo chemotherapy. Participants will be randomly assigned to either an exercise and medical nutrition intervention group, which includes weekly counseling sessions, or a control group receiving usual care. The study will assess the impact of the intervention on the relative dose intensity of chemotherapy and will include follow-up assessments at baseline, post-chemotherapy, and one year after diagnosis. Data will be collected from medical records following each chemotherapy session to evaluate outcomes.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with newly diagnosed epithelial ovarian cancer or advanced endometrial carcinoma scheduled for chemotherapy.
Not a fit: Patients who have already completed two cycles of chemotherapy or those who are already meeting high dietary and exercise guidelines may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the effectiveness of chemotherapy and overall health outcomes for women undergoing treatment for ovarian and endometrial cancer.
How similar studies have performed: Other studies have shown promising results with exercise and nutrition interventions in cancer care, suggesting potential benefits in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
New Haven, Connecticut and 1 other locations
- Yale University — New Haven, Connecticut, United States (Recruiting)
- University of Miami — Miami, Florida, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.