Back to resultsTrial of Exercise and Lifestyle in Women With Ovarian Cancer (TEAL)
Primary Purpose
Ovarian Cancer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise and medical nutrition
Sponsored by
About this trial
This is an interventional supportive care trial for Ovarian Cancer
Eligibility Criteria
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)
Sites / Locations
- Yale UniversityRecruiting
- University of MiamiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Exercise and medical nutrition
Control
Arm Description
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.
Contact limited to study assessments.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Change in Physical activity - subjective measure
Physical Activity Recall: The interviewer administered modified physical activity questionnaire (MPAQ) will measure physical activity.
Change in Neuropathy
The Functional Assessment of Cancer Therapy (FACT)-neuropathy subscale (FACT-GOG-Ntx) will be used to assess neuropathy (38 items).
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).
Change in Arthralgia
Arthralgia: Arthralgia will be assessed via the Brief Pain Inventory.
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.
Change in lower leg lymphedema
Lower leg lymphedema will be assessed using Gynecology Oncology Cancer Lymphedema Questionnaire.
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.
Change in waist circumference
Waist measurement will rounded up to the nearest millimeter.
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.
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.
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.
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.
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.
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.
Change in Social Support
Women will complete the MOS Social Support Survey Subscale.
Change in Social Activity
Women will complete the MOS Social Activity limitations Scale.
Change in Quality of life (SF-36)
Women will complete the Short Form Survey (SF-36) (36 items)
Change in Sleep Quality
Sleep Quality: Women will complete Pittsburgh Sleep Quality Index (PSQI).
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.
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.
Full Information
NCT ID
NCT05761561
First Posted
February 6, 2023
Last Updated
June 9, 2023
Sponsor
Yale University
Collaborators
University of Miami, National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT05761561
Brief Title
Trial of Exercise and Lifestyle in Women With Ovarian Cancer
Acronym
TEAL
Official Title
Trial of Exercise and Lifestyle (TEAL) in Women With Ovarian Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 14, 2023 (Actual)
Primary Completion Date
June 2026 (Anticipated)
Study Completion Date
June 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
University of Miami, National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise and medical nutrition
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Contact limited to study assessments.
Intervention Type
Behavioral
Intervention Name(s)
Exercise and medical nutrition
Intervention Description
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 Outcome Measure Information:
Title
Chemotherapy completion rate (relative dose intensity)
Description
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 months
Secondary Outcome Measure Information:
Title
Change in Skeletal muscle mass
Description
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 year
Title
Change in Muscle Mass assessed using D3Creatine dilution method
Description
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.
Title
Change in Healthy Eating Index-2020 (24-hour recall)
Description
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 year
Title
Change in Healthy Eating Index-2020 (FFQ)
Description
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 year
Title
Change in Physical activity - objective measure
Description
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.
Time Frame
Through study completion, an average of 1 year
Title
Change in Physical activity - subjective measure
Description
Physical Activity Recall: The interviewer administered modified physical activity questionnaire (MPAQ) will measure physical activity.
Time Frame
Through study completion, an average of 1 year
Title
Change in Neuropathy
Description
The Functional Assessment of Cancer Therapy (FACT)-neuropathy subscale (FACT-GOG-Ntx) will be used to assess neuropathy (38 items).
Time Frame
Through study completion, an average of 1 year
Title
Change in Cognitive function
Description
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).
Time Frame
Through study completion, an average of 1 year
Title
Change in Arthralgia
Description
Arthralgia: Arthralgia will be assessed via the Brief Pain Inventory.
Time Frame
Through study completion, an average of 1 year
Title
Change in GI disturbance
Description
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.
Time Frame
Through study completion, an average of 1 year
Title
Change in lower leg lymphedema
Description
Lower leg lymphedema will be assessed using Gynecology Oncology Cancer Lymphedema Questionnaire.
Time Frame
Through study completion, an average of 1 year
Title
Change in BMI
Description
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.
Time Frame
Through study completion, an average of 1 year
Title
Change in waist circumference
Description
Waist measurement will rounded up to the nearest millimeter.
Time Frame
Through study completion, an average of 1 year
Title
Change in Skin Carotenoids
Description
The Veggie meter will be used to measure carotenoid levels. This method is rapid and non-invasive, and measures skin carotenoids using optical signals.
Time Frame
Through study completion, an average of 1 year
Title
Change in Fitness
Description
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.
Time Frame
Through study completion, an average of 1 year
Title
Change in grip strength
Description
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.
Time Frame
Through study completion, an average of 1 year
Title
Change in blood biomarkers
Description
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.
Time Frame
Through study completion, an average of 1 year
Title
Change in financial toxicity
Description
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.
Time Frame
Through study completion, an average of 1 year
Title
Change in level of function and ability to perform specific tasks
Description
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.
Time Frame
Through study completion, an average of 1 year
Title
Change in Social Support
Description
Women will complete the MOS Social Support Survey Subscale.
Time Frame
Through study completion, an average of 1 year
Title
Change in Social Activity
Description
Women will complete the MOS Social Activity limitations Scale.
Time Frame
Through study completion, an average of 1 year
Title
Change in Quality of life (SF-36)
Description
Women will complete the Short Form Survey (SF-36) (36 items)
Time Frame
Through study completion, an average of 1 year
Title
Change in Sleep Quality
Description
Sleep Quality: Women will complete Pittsburgh Sleep Quality Index (PSQI).
Time Frame
Through study completion, an average of 1 year
Title
Change in Fatigue
Description
Fatigue: Women will complete Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue). Values : minimum = 0 and maximum = 52. Higher scores are worse outcome.
Time Frame
Through study completion, an average of 1 year
Title
Change in symptoms of chemotherapy assessed using the Common Terminology Criteria for Adverse Events (CTCAE)
Description
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.
Time Frame
Through end of chemotherapy, an average of 5 months.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melinda Irwin, PhD
Phone
203-499-9405
Email
melinda.irwin@yale.edu
Phone
203-499-9405
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tracy Crane, PhD
Phone
305-243-9832
Email
Tecrane@miami.edu
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Before making the data available to researchers not involved in the proposed study, we will ensure that the data to be shared are de-identified and comply with both IRB regulations and the Privacy Rule under HIPAA regulations. Under no circumstances will personal identifying information, such as name, address, telephone, medical record number be shared with anyone outside our research team.
Learn more about this trial
Trial of Exercise and Lifestyle in Women With Ovarian Cancer
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