Actively Recruiting
Trial of Exercise and Lifestyle for Women With Ovarian and Endometrial Cancer
Led by Yale University · Updated on 2025-06-03
200
Participants Needed
2
Research Sites
214 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
U
University of Miami
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Trial of Exercise and Lifestyle for Women With Ovarian and Endometrial Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of epithelial ovarian cancer, fallopian tube or primary peritoneal carcinoma, stage I-IV, or advanced/metastatic endometrial carcinoma including carcinosarcoma
- Scheduled to receive at least 6 cycles of neoadjuvant or adjuvant chemotherapy with carboplatin and taxane or equivalent
- Physically able to walk without a walking aid such as a cane or walker
- Able to complete forms, understand instructions, and read intervention materials in English or Spanish
- Agree to be randomly assigned to either study group
- Clearance from oncologist to participate
- At least 18 years of age
You will not qualify if you...
- Completed a second cycle of chemotherapy already
- Currently meeting dietary guidelines of more than 7 servings of fruits and vegetables per day
- Currently meeting physical activity guidelines of at least 150 minutes per week of moderate to vigorous exercise plus resistance training twice per week
- Pregnant or planning to become pregnant
- Recent history (within the past year) of stroke, heart attack, congestive heart failure, or ejection fraction below 40%
- Presence of dementia or major psychiatric illness
- Receiving active treatment including targeted or biologic therapies for any other cancer (except hormone therapy)
- Receiving external beam radiation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Yale University
New Haven, Connecticut, United States, 06511
Actively Recruiting
2
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here