Trial of Exercise and Lifestyle in Women With Ovarian Cancer

Ovarian Cancer Clinical Trial

— TEAL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05761561
• Other study ID #: 20211179
• Secondary ID: U01CA271278
• Status: Recruiting
• Phase: N/A
• Start date: April 19, 2023
• Est. completion date: June 2027

Study information

• Verified date: March 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

200 women with newly diagnosed OC 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 18-week exercise and medical nutrition intervention or attention control 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 (3-months post-chemotherapy and 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2027
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Behavioral:
• Exercise and medical nutrition
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).

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida
United States	Yale University	New Haven	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
Yale University	National Cancer Institute (NCI), University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in Arthralgia	Arthralgia: Arthralgia will be assessed via the Brief Pain Inventory.	Through study completion, an average of 1 year
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in waist circumference	Waist measurement will rounded up to the nearest millimeter.	Through study completion, an average of 1 year
Secondary	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
Secondary	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
Secondary	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
Secondary	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-a, CA-125.	Through study completion, an average of 1 year
Secondary	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
Secondary	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
Secondary	Change in Social Support	Women will complete the MOS Social Support Survey Subscale.	Through study completion, an average of 1 year
Secondary	Change in Social Activity	Women will complete the MOS Social Activity limitations Scale.	Through study completion, an average of 1 year
Secondary	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
Secondary	Change in Sleep Quality	Sleep Quality: Women will complete Pittsburgh Sleep Quality Index (PSQI).	Through study completion, an average of 1 year
Secondary	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
Secondary	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.