NCT04888988|Active Not RecruitingDMC

Testing the Effects of Exercise on Chemotherapy-Induced Peripheral Neuropathy

CIPN

Multi-Center Randomized Controlled Phase II Trial of Exercise to Treat Chemotherapy-Induced Peripheral Neuropathy (CIPN)

University of Rochester NCORP Research Base ClinicalTrials.gov

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5 other identifiers

URCC19075R21CA256154UG1CA189961NCI-2020-11456URCC-19075

Study Type

interventional

Target

133

Locations

1 country

Sites

Timeline

RegisteredMay 2021

StartedFeb 2022

CompletionJun 2026

Brief Summary

This phase II trial studies whether using exercise is better than the usual approach for treating chemotherapy-induced peripheral neuropathy (CIPN). CIPN occurs when chemotherapy damages the nerves communicating between the brain, spinal cord, and the rest of the body. The usual approach for treating CIPN is treatment with drugs that help reduce symptoms of other types of neuropathy (for example, from diabetes). However, these drugs do not treat all symptoms of CIPN. Exercise may help to reduce CIPN symptoms.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

133

participants targeted

Target at P50-P75 for not_applicable

Timeline

2mo left

Started Feb 2022

Longer than P75 for not_applicable

Geographic Reach

1 country

93 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

4.3 years study duration

Study Progress97%

Feb 2022Jun 2026

First Submitted

Initial submission to the registry

May 11, 2021

Completed

6 days until next milestone

First Posted

Study publicly available on registry

May 17, 2021

Completed

9 months until next milestone

Study Start

First participant enrolled

February 25, 2022

Completed

3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2025

Completed

8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

3.7 years

First QC Date

May 11, 2021

Last Update Submit

April 22, 2026

Conditions

Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm Chemotherapy-Induced Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

Chemotherapy-induced peripheral neuropathy (CIPN) symptom severity
Will estimate the effects of exercise versus usual care on CIPN using analysis of covariance (ANCOVA). Will be measured by the mean European Organization for Research and Treatment of Cancer-CIPN20. The model will include CIPN-20 at Week 6 as the outcome, treatment group (exercise vs. usual care) as the independent variable of interest and the pre-intervention CIPN-20 score as a covariate.
Week 6 post randomization

Secondary Outcomes (3)

Effects of exercise on the severity of CIPN symptoms
Up to 6 weeks post randomization
Effects of exercise on tactile sensitivity
Up to 6 weeks post randomization
Effect of exercise on interoception
Up to 6 weeks post randomization

Study Arms (2)

Arm 1 (EXCAP, tactile sensitivity test, counseling)

EXPERIMENTAL

Participants undergo the EXCAP intervention consisting of a home-based, self-directed, individually tailored progressive walking and resistance program for up to 6 weeks. Participants also undergo a tactile sensitivity test at baseline and after completion of EXCAP over 15-25 minutes. In addition, participants meet with a certified exercise instructor over 45 minutes at baseline and 2 additional booster meetings over 15-30 minutes during weeks 2 and 3 or weeks 4 and 5. Participants may optionally undergo MRI on study.

Other: Exercise CounselingOther: Exercise InterventionProcedure: Magnetic Resonance ImagingOther: Neuropathy AssessmentOther: Questionnaire Administration

Arm 2 (usual care, tactile sensitivity test)

ACTIVE COMPARATOR

Participants receive usual care for 6 weeks. At the end of the study, participants may receive the exercise kit and complete the EXCAP program as in Arm 1. Participants also undergo a tactile sensitivity test at baseline and after completion of EXCAP over 15-25 minutes. Participants may optionally undergo MRI on study.

Other: Best PracticeOther: Exercise CounselingOther: Exercise InterventionProcedure: Magnetic Resonance ImagingOther: Neuropathy AssessmentOther: Questionnaire Administration

Interventions

Best PracticeOTHER

Receive standard of care

Also known as: standard of care, standard therapy

Arm 2 (usual care, tactile sensitivity test)

Exercise CounselingOTHER

Meet with certified exercise instructor