Recruiting

Exercise & Nutrition

Sponsor:

Yale University

Code:

NCT05761561

Conditions

Ovarian Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Exercise and medical nutrition

Study Details

Brief summary:

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

Ovarian Cancer

Study ID

NCT05761561

Start date

Apr 19, 2023

Status verified date

Jul, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Exercise and medical nutrition

Over the intervention period (18 weeks on average - dependent on length of chemotherapy) women in the intervention arm will receive weekly counseling sessions, the study dietitian and exercise trainer will each conduct weekly sessions to assist the participants in achieving the diet and exercise study goals.

no intervention: Control

Contact limited to study assessments.

Interventions

Exercise and medical nutrition

The study dietitian and exercise trainer will each conduct weekly counseling sessions via telephone or zoom throughout the course of chemotherapy (approximately 18 weeks) to assist the participants in achieving the diet and exercise study goals. Participants will be provided written informational material, exercise bands for strength training and a Fitbit to record activity.

Participant goals are to: 1) participate in 150 min/week of moderate-intensity physical activity 2) participate in two weekly strength training sessions; 3) eat a combination of 5 or more servings of vegetables and/or fruits per day 4) consume 25 grams or more of fiber/day; 5) consume adequate amounts of protein to prevent muscle wasting (1.2g/kg body weight).

Primary outcome measure

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

Central Contacts and Locations

Locations

Yale University

Recruiting

New Haven, Connecticut, United States, 06511

Contacts

Melinda Irwin, PhD

203-499-9405melinda.irwin@yale.edu

203-499-9405

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Tracy Crane, PhD

305-243-9832Tecrane@miami.edu

More Information

Sponsor

Yale University

Last update posted

Jul 20, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Yale University on 2026-07-20.