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

NCT05761561 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-06-03

No results posted yet for this study

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

Interventions

BEHAVIORAL

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).

Sponsors & Collaborators

  • University of Miami

    collaborator OTHER

  • National Cancer Institute (NCI)

    collaborator NIH

  • Yale University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-19
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05761561 on ClinicalTrials.gov