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NCT05761561Recruiting

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

Trial of Exercise and Lifestyle (TEAL) for Women With Ovarian and Endometrial Cancer

Source: ClinicalTrials.gov · Last updated 20 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
200 (estimated)
First submitted
6 Feb 2023
Start date
19 Apr 2023
Primary completion date
Jun 2027
Lead sponsor
Yale University
NCT number
NCT05761561

What you commit to

  • Study type: Interventional
  • Planned participants: 200
  • From 19 Apr 2023 to the primary completion date, Jun 2027
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • having already completed a 2nd cycle of chemotherapy
  • receiving external beam radiation

Other illness

  • presence of dementia or major psychiatric disease
  • in active treatment including target or biologic therapies for any other cancer (excluding hormone therapy treatments)

Lab values

  • recent (past year) stroke/myocardial infarction or congestive heart failure/ejection fraction \<40%

Other

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Miami
Coordinator of this site? Confirm its status
MiamiUnited StatesRecruiting
Yale University
Coordinator of this site? Confirm its status
New HavenUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.