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Exercise + Plant-Based Diet for Breast Cancer

Phase 2

Waitlist Available

Led By Neil Iyengar, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18

Patients with histologically-confirmed, HR-positive (ER and/or PR) stage 1-3 breast cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks post-intervention

Awards & highlights

Study Summary

This trial will study whether exercise and a plant-based diet can lower aromatase levels in overweight postmenopausal women being treated with an aromatase inhibitor for HR+ breast cancer. Additionally, the trial will look at other ways these interventions might affect the body and quality of life.

Who is the study for?

This trial is for overweight postmenopausal women with hormone receptor-positive breast cancer stages 1-3, who are sedentary and currently treated with an aromatase inhibitor. Participants must be willing to follow the study procedures, have completed any anti-HER2 or chemotherapy treatments at least 3 months prior, and not have any other active cancers or conditions that would limit their ability to exercise.Check my eligibility

What is being tested?

The study investigates how a combination of exercise treatment and a plant-based diet affects aromatase levels in participants. It also examines changes in gene expression within breast tissue and overall quality of life improvements due to these interventions.See study design

What are the potential side effects?

While specific side effects are not listed for this type of lifestyle intervention trial, potential risks may include muscle soreness from increased physical activity and dietary changes which could lead to gastrointestinal discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My breast cancer is in stages 1-3 and hormone receptor positive.

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I am postmenopausal.

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I finished my chemotherapy at least 3 months ago.

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I am fully active or can carry out light work.

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I have a breast that can be biopsied.

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I have finished treatment specifically for HER2-positive cancer.

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I am currently on hormone therapy for cancer using an aromatase inhibitor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks post-intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks post-intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks post-intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

change in breast aromatase levels

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Exercise Treatment and Plant-Based DietExperimental Treatment3 Interventions

Will consist of structured exercise treatment plus a calorie-restricted plant-based diet. Exercise treatment will consist of individualized walking delivered up to 7 times weekly to achieve the patient-specific goal energy expenditure. Training sessions will be performed on a treadmill under remote surveillance using a telemedicine approach (i.e.,TeleEx) established in the Exercise-Oncology (ExOnc) Service. Pre-prepared meals, including 6 dinners and 6 lunches per week, will be shipped to the partipant's home during the intervention. If a patient is temporarily unable to complete supervised sessions as a result of unforeseen circumstances, patients may be assigned low intensity unsupervised training sessions per EP/PI discretion

Group II: Physical activity and nutrition counselingActive Control2 Interventions

Patients will receive a home-based, general physical activity program and nutrition counseling. Specifically, all patients assigned to the counseling arm will receive a study kit which includes an activity tracker, heart rate monitor, scale, and tablet. Treadmills may also be provided to patients in the counseling arm if they do not already have access to one.

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Wake Forest UniversityOTHER

190 Previous Clinical Trials

164,557 Total Patients Enrolled

2 Trials studying Breast Cancer

734 Patients Enrolled for Breast Cancer

McGill UniversityOTHER

397 Previous Clinical Trials

1,000,225 Total Patients Enrolled

4 Trials studying Breast Cancer

167 Patients Enrolled for Breast Cancer

University of Kansas Medical CenterOTHER

467 Previous Clinical Trials

169,215 Total Patients Enrolled

22 Trials studying Breast Cancer

4,467 Patients Enrolled for Breast Cancer

Media Library

Exercise Treatment Clinical Trial Eligibility Overview. Trial Name: NCT04298086 — Phase 2

Breast Cancer Research Study Groups: Exercise Treatment and Plant-Based Diet, Physical activity and nutrition counseling

Breast Cancer Clinical Trial 2023: Exercise Treatment Highlights & Side Effects. Trial Name: NCT04298086 — Phase 2

Exercise Treatment 2023 Treatment Timeline for Medical Study. Trial Name: NCT04298086 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any Canadian locations where this clinical trial is currently taking place?

"At the moment, 7 clinical trial sites are welcoming enrollees. These locales span from New york to Harrison and Commack as well as additional areas in close proximity. To reduce travel, it is advisable to pick a site nearby if you decide to join this research study."

Answered by AI

Has Exercise Treatment been sanctioned by the Federal Drug Administration?

"While there is limited evidence to suggest the efficacy of Exercise Treatment, it was still given a score of 2 due to its established safety profile."

Answered by AI

Are there any available spots for participants in this trial?

"Affirmative. According to the information housed on clinicaltrials.gov, this experiment is currently recruiting volunteers; it was originally posted on March 4th 2020 and edited as recently as September 21st 2021. In total, 62 individuals will be chosen from 7 different trial sites."

Answered by AI

What is the total capacity of this research trial?

"Affirmative. Clinicaltrials.gov reveals that the study is actively seeking participants, which was initially uploaded on March 4th 2020 and last modified on September 21st 2022. 62 individuals are planned to be enrolled at 7 medical facilities across the country."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of the Body's Response to Exercise and a Plant-Based Diet in Overweight Postmenopausal Women With Breast Cancer

2020. "A Study of the Body's Response to Exercise and a Plant-Based Diet in Overweight Postmenopausal Women With Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04298086.