Ovarian CancerTEALNCT05761561
Trial of Exercise and Lifestyle for Women With Ovarian and Endometrial Cancer
A study testing Exercise and medical nutrition in people with Ovarian Cancer, run by Yale University at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Exercise and medical nutrition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Apr 2023to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Tracy Crane, PhD, 305-243-9832, Tecrane@miami.edu
- Recruiting
Yale University
New Haven, Connecticut, 06511
Melinda Irwin, PhD, 203-499-9405, melinda.irwin@yale.edu
203-499-9405
About this study
Official title: Trial of Exercise and Lifestyle (TEAL) 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.
Read more
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.
Read the detailed description
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.
- Conditions
- Ovarian Cancer
- Being tested
- Exercise and medical nutrition
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise and medical nutritionBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Exercise and medical nutrition | Experimental | 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. Receives: Behavioral: Exercise and medical nutrition |
| Control | No intervention | Contact limited to study assessments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through end of first line chemotherapy, an average of 5 months
Secondary outcomes (25)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Through study completion, an average of 1 year
Change in Arthralgia
Arthralgia: Arthralgia will be assessed via the Brief Pain Inventory.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 1 year
Change in waist circumference
Waist measurement will rounded up to the nearest millimeter.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 1 year
Change in blood biomarkers
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.
Measured: 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.
Measured: 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) (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.
Measured: Through study completion, an average of 1 year
Change in Social Support
Women will complete the MOS Social Support Survey Subscale.
Measured: Through study completion, an average of 1 year
Change in Social Activity
Women will complete the MOS Social Activity limitations Scale.
Measured: 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)
Measured: Through study completion, an average of 1 year
Change in Sleep Quality
Sleep Quality: Women will complete Pittsburgh Sleep Quality Index (PSQI).
Measured: 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.
Measured: 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.
Measured: Through end of chemotherapy, an average of 5 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start19 Apr 2023
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Miami, National Cancer Institute (NCI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05761561
- Sponsor's protocol ID
- 20211179
- Other IDs
- U01CA271278
- Acronym
- TEAL
- Status last verified
- Jul 2026
- First submitted
- 6 Feb 2023
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Exercise and Lifestyle (TEAL) for Women With Ovarian and Endometrial Cancer
- ClinicalTrials.gov ID
- NCT05761561
- Acronym / sponsor ID
- TEAL / 20211179
- Conditions
- Ovarian Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- University of Miami, National Cancer Institute (NCI)
- Study start
- 19 Apr 2023 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 9 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise and medical nutrition | Experimental | Behavioral: Exercise and medical nutritionOver 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. |
| Control | No intervention | –Contact limited to study assessments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise and medical nutritionThe 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). | Behavioural | Exercise and medical nutrition |
Primary outcome
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.
25 secondary outcomes
Change in Skeletal muscle mass
Time frame: Through study completion, an average of 1 year
Change in Muscle Mass assessed using D3Creatine dilution method
Time frame: Through end of first line chemotherapy, an average of 5 months.
Change in Healthy Eating Index-2020 (24-hour recall)
Time frame: Through study completion, an average of 1 year
Change in Healthy Eating Index-2020 (FFQ)
Time frame: Through study completion, an average of 1 year
Change in Physical activity - objective measure
Time frame: Through study completion, an average of 1 year
Change in Physical activity - subjective measure
Time frame: Through study completion, an average of 1 year
Change in Neuropathy
Time frame: Through study completion, an average of 1 year
Change in Cognitive function
Time frame: Through study completion, an average of 1 year
Change in Arthralgia
Time frame: Through study completion, an average of 1 year
Change in GI disturbance
Time frame: Through study completion, an average of 1 year
Change in lower leg lymphedema
Time frame: Through study completion, an average of 1 year
Change in BMI
Time frame: Through study completion, an average of 1 year
Change in waist circumference
Time frame: Through study completion, an average of 1 year
Change in Skin Carotenoids
Time frame: Through study completion, an average of 1 year
Change in Fitness
Time frame: Through study completion, an average of 1 year
Change in grip strength
Time frame: Through study completion, an average of 1 year
Change in blood biomarkers
Time frame: Through study completion, an average of 1 year
Change in financial toxicity
Time frame: Through study completion, an average of 1 year
Change in level of function and ability to perform specific tasks
Time frame: Through study completion, an average of 1 year
Change in Social Support
Time frame: Through study completion, an average of 1 year
Change in Social Activity
Time frame: Through study completion, an average of 1 year
Change in Quality of life (SF-36)
Time frame: Through study completion, an average of 1 year
Change in Sleep Quality
Time frame: Through study completion, an average of 1 year
Change in Fatigue
Time frame: Through study completion, an average of 1 year
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and medical nutrition in people with Ovarian Cancer, run by Yale University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chemotherapy completion rate (relative dose intensity) (time frame: Through end of first line chemotherapy, an average of 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.