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Fasting + Exercise for Breast Cancer

N/A

Waitlist Available

Led By Jennifer Ligibel, MD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

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

Must have

> 18 years of age

Diagnosis of ER and/or PR+ metastatic or locally unresectable breast cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial is testing whether a 12-week program of nightly fasting and exercise helps improve outcomes for women with metastatic breast cancer who are starting endocrine therapy with palbociclib or alpelisib.

Who is the study for?

This trial is for postmenopausal women over 18 with HR+ metastatic breast cancer starting treatment with palbociclib or alpelisib. Participants should be able to walk two blocks, have their oncologist's approval, and understand English. Women already doing more than 90 minutes of exercise a week or those on diabetes medication can't join.Check my eligibility

What is being tested?

The study tests if not eating for an extended time each night (12 weeks) combined with exercise affects metabolic markers and how patients feel while they start endocrine therapy with palbociclib or alpelisib for their breast cancer.See study design

What are the potential side effects?

Since the interventions are prolonged nightly fasting and exercise, side effects may include hunger, fatigue during adjustment periods, potential muscle soreness from new physical activity routines, and possible changes in blood sugar levels.

Eligibility Criteria

Inclusion Criteria

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

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I am older than 18 years.

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My breast cancer is ER or PR positive and cannot be surgically removed.

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I am postmenopausal or using ovarian suppression.

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I can walk two blocks without help.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Rate of adherence to exercise intervention goals

Rate of adherence to prolonged overnight fasting (POF) intervention goals

Rate of enrollment

Secondary outcome measures

Change in quality of life and patient-reported outcome measures between baseline and week 12

Changes in metabolic biomarkers between baseline and week 12

Differences in changes in metabolic biomarkers by treatment group (palbociclib vs palbocilib)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Prolonged Nightly Fasting Plus ExerciseExperimental Treatment2 Interventions

Participants will be grouped into two cohorts determined by whether they receive palbociclib or alpelisib as part of their breast cancer treatment and then receive a 12 week prolonged nightly fasting plus exercise program consisting of: Prolonged overnight fasting: Not consume any calorie-containing food/drinks after 8pm, waiting a minimum of 13 hours after their last meal of the day before eating the next day, target goal of fasting at least 6 days a week, daily record of first and last meals Exercise Program: Coach provided at-home, personalized exercise regimen with target goal of 120 minutes of moderate-intensity aerobic activity each week as well as two 30-45-minute virtual strength training classes per week, receive fitbit for exercise and heart rate monitoring, weekly telephone-based support sessions with coach.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Exercise

2016

Completed Phase 1

~760

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor

1,078 Previous Clinical Trials

340,842 Total Patients Enrolled

141 Trials studying Breast Cancer

22,587 Patients Enrolled for Breast Cancer

Jennifer Ligibel, MDPrincipal InvestigatorDana-Farber Cancer Institute

9 Previous Clinical Trials

3,936 Total Patients Enrolled

7 Trials studying Breast Cancer

699 Patients Enrolled for Breast Cancer

Frequently Asked Questions

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

Are there currently openings in this research endeavor for volunteers?

"According to clinicaltrials.gov, the posted research study is not recruiting new participants as of 11/28/2022. However, 2612 other trials are presently in need of volunteers. This particular trial was originally uploaded on 1/15/2021."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Feasibility of Fasting & Exercise in Pts With HR+ MBC

Jennifer A. Ligibel, MD 2021. "Feasibility of Fasting & Exercise in Pts With HR+ MBC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04708860.