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

NCT05761561 | Recruiting DMC

• 2 other identifiers: 20211179U01CA271278
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Chemotherapy completion rate (relative dose intensity)

  Chemotherapy completion rate will be assessed as the average relative dose intensity for the originally planned regimen based on standard formulas. This will be measured using the number and percent of patients requiring dose-adjustments, dose-delays, reason for dose.

  Through end of first line chemotherapy, an average of 5 months

Secondary Outcomes (25)

• Change in Skeletal muscle mass

  Through study completion, an average of 1 year

• Change in Muscle Mass assessed using D3Creatine dilution method

  Through end of first line chemotherapy, an average of 5 months.

• Change in Healthy Eating Index-2020 (24-hour recall)

  Through study completion, an average of 1 year

• Change in Healthy Eating Index-2020 (FFQ)

  Through study completion, an average of 1 year

• Change in Physical activity - objective measure

  Through study completion, an average of 1 year

Study Arms (2)

Exercise and medical nutrition

EXPERIMENTAL

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.

Behavioral: Exercise and medical nutrition

Control

NO INTERVENTION

Contact limited to study assessments.

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).

Exercise and medical nutrition

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• University of Miami: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Yale University

New Haven, Connecticut, 06511, United States

RECRUITING

University of Miami

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: March 9, 2023
• Study Start: April 19, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 3, 2025

Record last verified: 2025-05

Locations

US (2)