Trial of Exercise and Lifestyle for Women With Ovarian and Endometrial Cancer
ConditionOvarian Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorYale University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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%
Trial design
Design model
Parallel
Treatments tested in this trial
Exercise and medical nutrition
BehavioralThe 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).
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Exercise and medical nutritionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
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.
Time frame
Through end of first line chemotherapy, an average of 5 monthsSecondary outcomes
1
Change in Skeletal muscle mass
Skeletal muscle mass will be assessed assessed using CT scans. The L3 slice used for analysis will be within 3-5mm of the lower border of the L3 vertebral body across individuals. A multiple-step procedure will be used to segment images into skeletal muscle, excluding visceral adipose tissue, subcutaneous adipose tissue, organs, vessels, and bony structures.
Time frame
Through study completion, an average of 1 year2
Change in Muscle Mass assessed using D3Creatine dilution method
A capsule of D3Creatine will be given to the participant to ingest. Fasting urine sample is then collected between 2-5 days after the dose is ingested and sent for analysis. For subsequent measurements, there is some residual D3Cr remaining in muscle, so a pre- D3Creatine dose urine sample is needed to measure the D3Cr enrichment from the initial dose and a sample taken 2-5 days after the dose.
Time frame
Through end of first line chemotherapy, an average of 5 months.3
Change in Healthy Eating Index-2020 (24-hour recall)
24-Hour Dietary Recall will be assessed. Two 24-hour recalls (1 weekday and weekend day, 30-40 minutes to complete) will be captured. Interviewers record all food and beverage consumption over a 24-hour period using the USDA multi-pass method with the University of Minnesota Nutrition Data System-Research Version system. The two days at each time point will be averaged and calories (kcal), nutrients, and diet quality assessed. Diet quality will be calculated using the HEI-2020; range of 0 - 100, higher score indicating better diet quality.
Time frame
Through study completion, an average of 1 year4
Change in Healthy Eating Index-2020 (FFQ)
Recent diet will be assessed via food frequency questionnaire (FFQ). Diet quality will be calculated using the HEI-2020; range of 0 - 100, higher score indicating better diet quality.
Time frame
Through study completion, an average of 1 yearSponsors and contacts
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Yale University
Lead sponsor
University of Miami
Collaborator
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov