Trial of Exercise and Lifestyle in Women With Ovarian Cancer

Study Overview
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Brief Summary
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An anticipated 200 women with newly diagnosed ovarian 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.

Official Title
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Trial of Exercise and Lifestyle (TEAL) in Women With Ovarian Cancer

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Behavioral: Exercise and medical nutrition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: have a diagnosis of epithelial ovarian cancer, fallopian tube or primary peritoneal carcinoma, stage I-IV be scheduled to receive 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 (>5 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise and medical nutrition<br>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<br>* 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).<br>|
| No Intervention: Control<br>Contact limited to study assessments. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Through study completion, an average of 1 year | 
| 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. | Through end of first line chemotherapy, an average of 5 months. | 
| 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. | Through study completion, an average of 1 year | 
| 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. | Through study completion, an average of 1 year | 
| Change in Physical activity - objective measure | Participants will receive an Actigraph GTX9 accelerometer and instructed to wear it on the waist for 7 continuous days. From the Actigraph GTX9, daily summary moderate to vigorous physical activity will be calculated. | Through study completion, an average of 1 year | 
| Change in Physical activity - subjective measure | Physical Activity Recall: The interviewer administered modified physical activity questionnaire (MPAQ) will measure physical activity. | Through study completion, an average of 1 year | 
| Change in Neuropathy | The Functional Assessment of Cancer Therapy (FACT)-neuropathy subscale (FACT-GOG-Ntx) will be used to assess neuropathy (38 items). | Through study completion, an average of 1 year | 
| Change in Cognitive function | Cognitive function will be assessed using the Functional Assessment of Cancer Therapy (FACT)-Cog. This self-administered questionnaire includes four subscales, 'Perceived Cognitive Impairments' (20 items), 'Impact of Quality of Life' (4 items) , 'Comments from Others' (4 items), and 'Perceived Cognitive Abilities' (9 items). | Through study completion, an average of 1 year | 
| Change in Arthralgia | Arthralgia: Arthralgia will be assessed via the Brief Pain Inventory. | Through study completion, an average of 1 year | 
| Change in GI disturbance | The 13-item Gastrointestinal Symptom Rating Scale developed for patients with Irritable Bowel Syndrome (GSRS-IBS)with subscales on satiety, abdominal pain, diarrhea, constipation, and bloating, will be used to assess GI disturbance. | Through study completion, an average of 1 year | 
| Change in lower leg lymphedema | Lower leg lymphedema will be assessed using Gynecology Oncology Cancer Lymphedema Questionnaire. | Through study completion, an average of 1 year | 
| Change in BMI | Participants will be weighed in light clothing, without shoes, rounding up to the nearest 0.1 kg. Height will be measured without shoes, using a stadiometer, rounding up to the nearest 0.1 cm. BMI will be calculated from the measured weight and height. | Through study completion, an average of 1 year | 
| Change in waist circumference | Waist measurement will rounded up to the nearest millimeter. | Through study completion, an average of 1 year | 
| Change in Skin Carotenoids | The Veggie meter will be used to measure carotenoid levels. This method is rapid and non-invasive, and measures skin carotenoids using optical signals. | Through study completion, an average of 1 year | 
| Change in Fitness | Participants will be complete a 6-minute walk test following the American Thoracic Society's standardized protocol, with the score equal to the distance walked in 6 minutes in meters. | Through study completion, an average of 1 year | 
| Change in grip strength | Grip strength assessed by dynamometer. Handgrip strength is a valid, simple measure of muscle strength that correlates well with leg strength, poor mobility, and incident disability in activities of daily living. | Through study completion, an average of 1 year | 
| Change in blood biomarkers | Fasting bloods will be taken. Plasma, serum and buffy coat samples will be prepared and frozen at -80 degrees C. Potential blood biomarkers include: glucose, insulin, leptin, VEGF, CRP, IL-6, TNF-α, CA-125. | Through study completion, an average of 1 year | 
| Change in financial toxicity | Financial toxicity will be assessed using the Functional Assessment of Chronic Illness Therapy-COST (FACIT-COST), a measure of financial toxicity (financial distress). Values : minimum = 0 and maximum = 48. Higher scores are worse outcome. | Through study completion, an average of 1 year | 
| Change in level of function and ability to perform specific tasks | Women will complete the Functional Assessment of Cancer Therapy (FACT)-ovarian cancer subscale (FACT-O) to level of function and ability to perform specific tasks. | Through study completion, an average of 1 year | 
| Change in Social Support | Women will complete the MOS Social Support Survey Subscale. | Through study completion, an average of 1 year | 
| Change in Social Activity | Women will complete the MOS Social Activity limitations Scale. | Through study completion, an average of 1 year | 
| Change in Quality of life (SF-36) | Women will complete the Short Form Survey (SF-36) (36 items) | Through study completion, an average of 1 year | 
| Change in Sleep Quality | Sleep Quality: Women will complete Pittsburgh Sleep Quality Index (PSQI). | Through study completion, an average of 1 year | 
| Change in Fatigue | Fatigue: Women will complete Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue). Values : minimum = 0 and maximum = 52. Higher scores are worse outcome. | Through study completion, an average of 1 year | 
| Change in symptoms of chemotherapy assessed using the Common Terminology Criteria for Adverse Events (CTCAE) | The Common Terminology Criteria for Adverse Events (CTCAE) will be used to assess symptoms. This well-validated survey includes symptoms and adverse events related to chemotherapy. The constructs we will measure include dry mouth, mouth/throat sores, taste, appetite, nausea, vomiting, heartburn, constipation, diarrhea, abdominal pain, shortness of breath, dizziness, neuropathy, concentration, memory, pain, insomnia, anxiety, hot flashes and fatigue. | Through end of chemotherapy, an average of 5 months. |