Lifestyle Changes for Ovarian Cancer

(TEAL Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Yale University

Must not be taking: Target therapies, Biologic therapies

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

Stay on Your Current Meds

No Placebo Group

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.

Trial 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 (Behavioral Intervention)

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Yale University New Haven, CT

University of Miami Miami, FL

Who Is Running the Clinical Trial?

Yale University Lead Sponsor

University of Miami Collaborator

National Cancer Institute (NCI) Collaborator

References

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

Feasibility of a lifestyle intervention for ovarian cancer patients receiving adjuvant chemotherapy. [2022] This study aimed to assess the feasibility of a lifestyle intervention for promoting physical activity (PA) and diet quality during adjuvant chemotherapy for ovarian cancer.

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

A healthy lifestyle and survival among women with ovarian cancer. [2021] Ovarian cancer has a poor survival rate and, understandably, women often want to know whether there is anything they can do to improve their prognosis. Our goal was to investigate the association between a healthy lifestyle prediagnosis and postdiagnosis and survival in a cohort of Australian women with invasive epithelial ovarian cancer. We calculated a healthy lifestyle index (HLI) based on women's self-reported smoking status, height, weight, physical activity, diet and alcohol consumption before diagnosis (n = 678) and after completing primary treatment (n = 512). Clinical data and vital status for each woman were ascertained through medical records. Cox proportional hazards regression was conducted to calculate hazard ratios (HR) and 95% confidence interval (CI) for all-cause mortality. There was a suggestive association between a more healthy lifestyle before diagnosis and better survival (HR 0.79, 95% CI: 0.59-1.04), however, the association was stronger for lifestyle after diagnosis, with women in the highest tertile having significantly better survival than women in the lowest tertile (HR 0.61, 95% CI: 0.40-0.93; P-trend = .02). Current smoking, particularly postdiagnosis, was associated with higher mortality (HR 1.68, 95% CI: 1.17-2.42; HR 2.82, 95% CI: 1.29-6.14, for prediagnosis and postdiagnosis smoking, respectively), but women who quit after diagnosis had survival outcomes similar to nonsmokers (HR 0.99, 95% CI: 0.57-1.72). Higher physical activity after diagnosis was associated with better survival (HR 0.60, 95% CI: 0.39-0.92; P-trend = .02). A healthy lifestyle after diagnosis, in particular not smoking and being physically active, may help women with ovarian cancer improve their prognosis.

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] Data on the treatment-supporting effect of modifiable lifestyle factors such as nutrition and physical activity on survival or quality of life (QoL) are scarce in patients with ovarian cancer. Despite a strong rationale for evaluating the effect of a multimodal intervention and multiple studies targeting other cancer sites, randomized controlled trials (RCTs) on the effects of a combined nutrition and exercise intervention on survival and QoL in ovarian cancer patients are rare. No study has investigated the impact of an early intervention during first-line chemotherapy.

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

Exercise during CHemotherapy for Ovarian cancer (ECHO) trial: design and implementation of a randomised controlled trial. [2023] Label="INTRODUCTION">Epidemiological evidence supports an association between higher levels of physical activity and improved cancer survival. Trial evidence is now needed to demonstrate the effect of exercise in a clinical setting. The Exercise during CHemotherapy for Ovarian cancer (ECHO) trial is a phase III, randomised controlled trial, designed to determine the effect of exercise on progression-free survival and physical well-being for patients receiving first-line chemotherapy for ovarian cancer.

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] Ovarian cancer is the most common cause of gynecological cancer death in United States women. Efforts to improve progression free survival (PFS) and quality of life (QoL) after treatment for ovarian cancer are necessary. Observational studies suggest that lifestyle behaviors, including diet and physical activity, are associated with lower mortality in this population. The Lifestyle Intervention for Ovarian Cancer Enhanced Survival (LIVES) NRG 0225 study is a randomized, controlled trial designed to test the hypothesis that a 24month lifestyle intervention will significantly increase PFS after oncological therapy for stage II-IV ovarian cancer. Women are randomized 1:1 to a high vegetable and fiber, low-fat diet with daily physical activity goals or an attention control group. Secondary outcomes to be evaluated include QoL and gastrointestinal health. Moreover an a priori lifestyle adherence score will be used to evaluate relationships between adoption of the diet and activity goals and PFS. Blood specimens are collected at baseline, 6, 12 and 24months for analysis of dietary adherence (carotenoids) in addition to mechanistic biomarkers (lipids, insulin, telomere length). Women are enrolled at NRG clinic sites nationally and the telephone based lifestyle intervention is delivered from The University of Arizona call center by trained health coaches. A study specific multi-modal telephone, email, and SMS behavior change software platform is utilized for information delivery, coaching and data capture. When completed, LIVES will be the largest behavior-based lifestyle intervention trial conducted among ovarian cancer survivors.

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

Exercise Among Women With Ovarian Cancer: A Feasibility and Pre-/Post-Test Exploratory Pilot Study. [2018] To establish the feasibility and acceptability of completing a higher dose of the planned physical activity volume among women with ovarian cancer, including those undergoing active treatment. .

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] Physical activity has become increasingly important in supportive cancer care. However, physical activity and exercise guidelines for ovarian cancer survivors remain generic. The aim of this narrative review is to summarize existing data regarding the physiological characteristics (treatment-related adverse effects, concurrent comorbidities, body weight and composition, physical fitness and function, and physical activity behavior) of ovarian cancer survivors to further understanding of their cancer-specific physical activity and exercise needs. We also highlight gaps in the current knowledge base.

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] The Lifestyle Intervention for oVarian cancer Enhanced Survival (LIVES) is a national study of a combined diet and physical activity intervention for stage II-IV ovarian cancer survival, an under-represented cancer in lifestyle behavioral intervention research. Here, we present the data on recruitment, retention, and baseline demographic, clinical and lifestyle behavior characteristics of the LIVES study participants.