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Lifestyle, Exercise, and Nutrition Study Early After Diagnosis

NCT03314688 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 173

Last updated 2025-02-03

Study results available
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Summary

The proposed study is a randomized trial evaluating the impact of a dietary and physical activity guidelines intervention vs. usual care on adherence to breast cancer treatments, body composition, and changes in biomarkers in 172 women newly diagnosed with breast cancer scheduled to receive neoadjuvant or adjuvant chemotherapy.

Conditions

  • Breast Neoplasms

Interventions

BEHAVIORAL

Dietary/Physical Activity intervention

Motivational counseling to follow established dietary and exercise guidelines.

BEHAVIORAL

Usual Care

Standard follow-up care and educational materials. Lifestyle counseling offered at the conclusion of the trial.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Yale University

    lead OTHER

Principal Investigators

  • Melinda Irwin, Ph.D. · Yale University

  • Tara Sanft, M.D. · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-02
Primary Completion
2023-03-24
Completion
2026-07-31

Countries

  • United States

Study Locations

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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 NCT03314688 on ClinicalTrials.gov