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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT05761561
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Exercise and medical nutrition — BEHAVIORAL
    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).

Study Details

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.

Key Dates

Start date
Apr 19, 2023
Status verified
May 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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.

Primary Outcome Measure

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

Locations (2)

FacilityCityStateZIPSite coordinators
Yale UniversityNew HavenConnecticut06511
Melinda Irwin, PhD
[email protected]
203-499-9405
203-499-9405
University of MiamiMiamiFlorida33136
Tracy Crane, PhD
[email protected]
305-243-9832

Find similar trials in New Haven, CT

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Yale University· New Haven, CTUniversity of Miami· Miami, FL

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