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Exercise and Nutrition Interventions During Chemotherapy K07

NCT03858153 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-12-22

No results posted yet for this study

Summary

Chemotherapy-induced peripheral neuropathy (CIPN) is a highly prevalent and severe side-effect of taxane chemotherapy, often used to treat breast cancer. Unfortunately there are very limited treatments for CIPN. This is a phase II randomized controlled trial to test the preliminary efficacy of exercise vs. nutrition education on CIPN, to systematically investigate the potential roles of inflammation and interoception, and to obtain data with a more accurate effect size to inform a future study.

Conditions

  • Neuropathy;Peripheral

Interventions

BEHAVIORAL

Nutrition Education

12 weeks of implementing eating tips and tracking food.

BEHAVIORAL

EXCAP Exercise

12 weeks of at-home walking and resistance exercise.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Rochester

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-15
Primary Completion
2025-08-27
Completion
2025-08-27

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 NCT03858153 on ClinicalTrials.gov