Lifestyle Changes for Ovarian Cancer

(TEAL Trial)

Recruiting at 1 trial location

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Yale University

Must not be taking: Target therapies, Biologic therapies

Disqualifiers: Pregnancy, Stroke, Heart failure, Dementia, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 18 weeks

200 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does mention that you should not be in active treatment with target or biologic therapies for any other cancer, except for hormone therapy treatments.

What data supports the effectiveness of the treatment Exercise and medical nutrition, Physical Activity, Dietary Intervention, Lifestyle Modification for ovarian cancer?

Research suggests that a healthy lifestyle, including regular physical activity and a good diet, can improve survival rates for women with ovarian cancer. Studies show that women who are more physically active and maintain a healthy lifestyle after diagnosis have better survival outcomes. ^{1 2 3 4 5}

Is it safe for ovarian cancer patients to participate in lifestyle interventions involving exercise and diet?

Research on lifestyle interventions, including exercise and diet, for ovarian cancer patients suggests these approaches are generally safe. Studies have focused on the feasibility and acceptability of such interventions, indicating they can be safely integrated into cancer care. ^{1 4 5 6 7}

How does the lifestyle intervention treatment for ovarian cancer differ from other treatments?

This lifestyle intervention treatment for ovarian cancer is unique because it focuses on improving diet and physical activity to enhance survival and quality of life, rather than relying solely on traditional medical treatments like chemotherapy. It involves a structured program with a high vegetable and fiber, low-fat diet, and daily exercise goals, supported by health coaching and digital tools. ^{1 2 3 5 8}

Eligibility Criteria

This trial is for women over 18 with newly diagnosed ovarian cancer who are about to start chemotherapy. They must be able to walk unaided and understand English or Spanish. Women can't join if they're pregnant, have severe mental health issues, are in active treatment for another cancer (except hormone therapy), have already started their second chemo cycle, follow certain diet/exercise guidelines since diagnosis, or have had recent serious heart problems.

Inclusion Criteria

I can read and understand English or Spanish for forms and instructions.

I am 18 years old or older.

I have been diagnosed with ovarian, fallopian tube, or peritoneal cancer.

Exclusion Criteria

You have severe memory loss or serious mental illness.

I have not had a stroke, heart attack, or severe heart failure in the past year.

You are already following a healthy diet and exercising regularly since your diagnosis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive chemotherapy and are randomized to an exercise and medical nutrition intervention or control arm with weekly counseling sessions throughout chemotherapy

18 weeks

Weekly visits (in-person or virtual)

Post-chemotherapy/End of Intervention

A post-chemotherapy/end of intervention visit is conducted to assess outcomes

1 visit

Follow-up

Participants are monitored for safety and effectiveness after treatment at standard of care visits

12 months

3-months post-chemotherapy and 12-months post-diagnosis

Treatment Details

Interventions

• Exercise and medical nutrition

Trial Overview The study tests how exercise and medical nutrition affect women undergoing chemotherapy for ovarian cancer. Participants will either receive weekly counseling sessions on these interventions during their chemo treatment or be placed in a control group without the intervention. Assessments occur at baseline, after chemo/end of intervention, and one year post-diagnosis.

Participant Groups

Group I: Exercise and medical nutrition Experimental Treatment 1 Intervention

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.

Group II: Control Active Control 1 Intervention

Contact limited to study assessments.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

University of Miami

Collaborator

Trials

976

Recruited

423,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

A lifestyle intervention that included physical activity and nutrition counseling during chemotherapy for ovarian cancer was feasible, with 27 patients enrolled and a recruitment rate of 73%.

Patients showed improvements in quality of life, as measured by the FACT-G, which increased significantly from baseline to post-chemotherapy, suggesting that lifestyle counseling may enhance overall well-being during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a lifestyle intervention for ovarian cancer patients receiving adjuvant chemotherapy. von Gruenigen, VE., Frasure, HE., Kavanagh, MB., et al.[2022]

A healthy lifestyle after being diagnosed with ovarian cancer is strongly associated with better survival rates, with women adopting healthier habits showing a 39% lower risk of mortality compared to those with less healthy lifestyles.

Smoking, especially after diagnosis, significantly increases the risk of mortality, but women who quit smoking post-diagnosis have survival outcomes similar to non-smokers, highlighting the importance of lifestyle changes for improving prognosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A healthy lifestyle and survival among women with ovarian cancer. Hansen, JM., Nagle, CM., Ibiebele, TI., et al.[2021]

This study aims to evaluate the feasibility, safety, and acceptance of a combined nutrition and exercise intervention for women diagnosed with ovarian cancer during first-line chemotherapy, with a sample size of 30 patients.

The research is designed as a randomized controlled trial, comparing an intervention group receiving the nutrition and exercise program to a control group, which will help determine the impact of lifestyle factors on survival and quality of life in ovarian cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An exercise and nutrition intervention for ovarian cancer patients during and after first-line chemotherapy (BENITA study): a randomized controlled pilot trial. Maurer, T., von Grundherr, J., Patra, S., et al.[2020]

The ECHO trial is a phase III randomized controlled trial involving 500 women with newly diagnosed ovarian cancer, aiming to assess the impact of a structured exercise program on progression-free survival and physical well-being during first-line chemotherapy.

Participants in the exercise group will engage in 150 minutes of moderate-intensity exercise weekly, with outcomes including not only cancer progression but also quality of life, fatigue, and overall health, highlighting the potential benefits of exercise in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise during CHemotherapy for Ovarian cancer (ECHO) trial: design and implementation of a randomised controlled trial. Hayes, S., Obermair, A., Mileshkin, L., et al.[2023]

The LIVES NRG 0225 study is a large randomized controlled trial involving women with stage II-IV ovarian cancer, aiming to determine if a 24-month lifestyle intervention focused on a high vegetable and fiber, low-fat diet and increased physical activity can improve progression-free survival (PFS) after treatment.

This study will also assess quality of life (QoL) and gastrointestinal health, using a comprehensive approach that includes dietary adherence monitoring and mechanistic biomarker analysis, making it the largest behavior-based lifestyle intervention trial for ovarian cancer survivors to date.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of diet and physical activity in women treated for stage II-IV ovarian cancer: Rationale and design of the Lifestyle Intervention for Ovarian Cancer Enhanced Survival (LIVES): An NRG Oncology/Gynecologic Oncology Group (GOG-225) Study. Thomson, CA., Crane, TE., Miller, A., et al.[2023]

A 26-week home-based exercise program requiring 225 minutes of physical activity per week was found to be feasible and acceptable for women with ovarian cancer, with 80% of participants successfully completing the program.

Participants, including those undergoing chemotherapy, showed significant improvements in physical activity levels, with an increase of 1,593 average steps per day and 15 additional minutes of moderate-intensity activity, all without any adverse events reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Among Women With Ovarian Cancer: A Feasibility and Pre-/Post-Test Exploratory Pilot Study. Zhang, X., McClean, D., Ko, E., et al.[2018]

Ovarian cancer survivors often experience treatment-related symptoms and comorbidities that negatively impact their physical health, including high rates of overweight and obesity, malnutrition, and low muscle density, which can lead to worse survival outcomes.

There is a significant need for tailored physical activity and exercise interventions for ovarian cancer survivors, as many are insufficiently active or sedentary, but current knowledge gaps hinder the development of specific exercise guidelines for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Physiological Profile of Ovarian Cancer Survivors to Inform Tailored Exercise Interventions and the Development of Exercise Oncology Guidelines. Schofield, C., Newton, RU., Galvão, DA., et al.[2018]

The LIVES study successfully enrolled 1205 ovarian cancer survivors, exceeding recruitment goals, and achieved a high retention rate of over 88% during the 24-month diet and physical activity intervention trial.

The study aims to determine if lifestyle changes can improve progression-free survival in ovarian cancer patients, with participants showing a baseline diet low in fruits and vegetables and high sedentary time, highlighting the need for effective lifestyle interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle intervention in ovarian cancer enhanced survival (LIVES) study (NRG/GOG0225): Recruitment, retention and baseline characteristics of a randomized trial of diet and physical activity in ovarian cancer survivors. Thomson, CA., Crane, TE., Miller, A., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Feasibility of a lifestyle intervention for ovarian cancer patients receiving adjuvant chemotherapy. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A healthy lifestyle and survival among women with ovarian cancer. [2021]

3. England pubmed.ncbi.nlm.nih.gov

An exercise and nutrition intervention for ovarian cancer patients during and after first-line chemotherapy (BENITA study): a randomized controlled pilot trial. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Exercise during CHemotherapy for Ovarian cancer (ECHO) trial: design and implementation of a randomised controlled trial. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

A randomized trial of diet and physical activity in women treated for stage II-IV ovarian cancer: Rationale and design of the Lifestyle Intervention for Ovarian Cancer Enhanced Survival (LIVES): An NRG Oncology/Gynecologic Oncology Group (GOG-225) Study. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Exercise Among Women With Ovarian Cancer: A Feasibility and Pre-/Post-Test Exploratory Pilot Study. [2018]

7. England pubmed.ncbi.nlm.nih.gov

A Physiological Profile of Ovarian Cancer Survivors to Inform Tailored Exercise Interventions and the Development of Exercise Oncology Guidelines. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Lifestyle intervention in ovarian cancer enhanced survival (LIVES) study (NRG/GOG0225): Recruitment, retention and baseline characteristics of a randomized trial of diet and physical activity in ovarian cancer survivors. [2023]