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NCT Number: NCT05761561

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Yale University, New Haven, Connecticut, United States

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About this study

200 women with newly diagnosed ovarian or endometrial cancer scheduled to receive chemotherapy (adjuvant chemotherapy after surgery or neoadjuvant chemotherapy before surgery) will be recruited from Smilow Cancer Hospital at Yale Cancer Center (YCC) and Sylvester Comprehensive Cancer Center (SCCC) at University of Miami. If women are interested and eligible, the study team will obtain consent and collect baseline data. Participants will be randomized to an exercise and medical nutrition intervention (18 weeks dependent on length of chemotherapy) or usual care throughout therapy. After the standard 6 cycles of chemotherapy (~18 weeks), a post-chemotherapy/end of intervention visit will be conducted. Follow-up assessments will be at standard of care visits (12-months post-diagnosis). Data required to calculate the primary endpoint (relative dose intensity of chemotherapy) will be abstracted from the medical record directly following each chemotherapy session.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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).

Primary outcomes

  1. Chemotherapy completion rate (relative dose intensity)

    Time frame: Through end of first line chemotherapy, an average of 5 months

    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.

Secondary outcomes

  1. Change in Skeletal muscle mass

    Time frame: Through study completion, an average of 1 year

    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.

  2. Change in Muscle Mass assessed using D3Creatine dilution method

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

    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.

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

    Time frame: Through study completion, an average of 1 year

    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.

  4. Change in Healthy Eating Index-2020 (FFQ)

    Time frame: Through study completion, an average of 1 year

    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.

  5. Change in Physical activity - objective measure

    Time frame: Through study completion, an average of 1 year

    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.

  6. Change in Physical activity - subjective measure

    Time frame: Through study completion, an average of 1 year

    Physical Activity Recall: The interviewer administered modified physical activity questionnaire (MPAQ) will measure physical activity.

  7. Change in Neuropathy

    Time frame: Through study completion, an average of 1 year

    The Functional Assessment of Cancer Therapy (FACT)-neuropathy subscale (FACT-GOG-Ntx) will be used to assess neuropathy (38 items).

  8. Change in Cognitive function

    Time frame: Through study completion, an average of 1 year

    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).

  9. Change in Arthralgia

    Time frame: Through study completion, an average of 1 year

    Arthralgia: Arthralgia will be assessed via the Brief Pain Inventory.

  10. Change in GI disturbance

    Time frame: Through study completion, an average of 1 year

    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.

  11. Change in lower leg lymphedema

    Time frame: Through study completion, an average of 1 year

    Lower leg lymphedema will be assessed using Gynecology Oncology Cancer Lymphedema Questionnaire.

  12. Change in BMI

    Time frame: Through study completion, an average of 1 year

    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.

  13. Change in waist circumference

    Time frame: Through study completion, an average of 1 year

    Waist measurement will rounded up to the nearest millimeter.

  14. Change in Skin Carotenoids

    Time frame: Through study completion, an average of 1 year

    The Veggie meter will be used to measure carotenoid levels. This method is rapid and non-invasive, and measures skin carotenoids using optical signals.

  15. Change in Fitness

    Time frame: Through study completion, an average of 1 year

    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.

  16. Change in grip strength

    Time frame: Through study completion, an average of 1 year

    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.

  17. Change in blood biomarkers

    Time frame: Through study completion, an average of 1 year

    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.

  18. Change in financial toxicity

    Time frame: Through study completion, an average of 1 year

    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.

  19. Change in level of function and ability to perform specific tasks

    Time frame: Through study completion, an average of 1 year

    Women will complete the Functional Assessment of Cancer Therapy (FACT)-ovarian cancer subscale (FACT-O) (ovarian cancer patients) or the FACT-endometrial (FACT-EN) cancer subscale (endometrial cancer patients) to assess level of function and ability to perform specific tasks.

  20. Change in Social Support

    Time frame: Through study completion, an average of 1 year

    Women will complete the MOS Social Support Survey Subscale.

  21. Change in Social Activity

    Time frame: Through study completion, an average of 1 year

    Women will complete the MOS Social Activity limitations Scale.

  22. Change in Quality of life (SF-36)

    Time frame: Through study completion, an average of 1 year

    Women will complete the Short Form Survey (SF-36) (36 items)

  23. Change in Sleep Quality

    Time frame: Through study completion, an average of 1 year

    Sleep Quality: Women will complete Pittsburgh Sleep Quality Index (PSQI).

  24. Change in Fatigue

    Time frame: Through study completion, an average of 1 year

    Fatigue: Women will complete Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue). Values : minimum = 0 and maximum = 52. Higher scores are worse outcome.

  25. Change in symptoms of chemotherapy assessed using the Common Terminology Criteria for Adverse Events (CTCAE)

    Time frame: Through end of chemotherapy, an average of 5 months.

    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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Cancer Institute (NCI)
  • University of Miami

Registry information

Official study title

Trial of Exercise and Lifestyle (TEAL) for Women With Ovarian and Endometrial Cancer

Acronym: TEAL

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Mar 9, 2023
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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