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Feasibility of Fasting & Exercise in Pts With HR+ MBC

NCT04708860 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-08-16

No results posted yet for this study

Summary

This research is evaluating the impact of a 12-week prolonged nightly fasting (POF) and exercise intervention on metabolic markers and patient reported outcomes in women with metastatic breast cancer (MBC) initiating endocrine therapy in combination with palbociclib or alpelisib.

Conditions

Interventions

BEHAVIORAL

Prolonged Nightly Fasting

Restriction of consumption of calorie-containing food/drinks after 8pm

BEHAVIORAL

Exercise

Personalized moderate-intensity, aerobic exercise and strength training

Sponsors & Collaborators

Principal Investigators

  • Jennifer Ligibel, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-15
Primary Completion
2022-08-30
Completion
2024-07-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04708860 on ClinicalTrials.gov