Testing the Effects of Exercise on Chemotherapy-Induced Peripheral Neuropathy

Chemotherapy-Induced Peripheral Neuropathy Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

PRIMARY OBJECTIVE:

Assess the preliminary efficacy of exercise vs. standard care for treating CIPN (via patient-reported CIPN-20 total score).

SECONDARY OBJECTIVES:

I. Assess the preliminary efficacy of exercise vs. standard care on individual symptoms of CIPN (via CIPN Symptom Inventory; i.e., numbness, tingling, burning/shooting pain, and cramping in the hands and feet).

II. Assess the preliminary efficacy of exercise vs. standard care on a clinical test of CIPN symptoms (via the tactile sensitivity in the fingers and toes).

III. Assess the effects of exercise vs. standard care on possible CIPN mechanisms, namely interoception (via MAIA-2 questionnaire and/or insula-precuneus and insula-thalamus connectivity from brain fMRI).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM 1 Exercise Intervention Participants receive a 6-week home-based individually tailored progressive intervention, Exercise for Cancer Patients (EXCAP©®), consisting of walking and resistance band exercises. Participants receive an EXCAP kit, which includes an activity tracker, EXCAP manual, and resistance bands, meet with a certified exercise instructor for ~1 hour, and receive individualized walking and resistance band prescriptions. To enhance adherence to EXCAP intervention, the exercise instructor will conduct 2 additional Booster Meetings, each lasting 15-30 minutes, with participants during weeks 2 or 3 and weeks 4 or 5.

Participants will complete REDCap questionnaires and touch tests at baseline and post-intervention. Participants will also wear activity trackers and complete daily diary during the entire study period.

Participants may optionally complete magnetic resonance imaging (MRI) scans on the study.

ARM 2 Control condition (standard care) Participants receive their standard care. Participants will complete REDCap questionnaires and touch tests and wear activity trackers at baseline and post-intervention. Participants will also complete daily diary during the entire study period.

Participants may optionally complete magnetic resonance imaging (MRI) scans on the study.

Participants will be provided with the EXCAP©® program (i.e., EXCAP©® kit and all materials, one EXCAP©® teaching session with exercise instructor, and two Booster Meetings) after all study requirements have been completed at no cost to them. ;

Related Conditions & MeSH terms

• Chemotherapy-Induced Peripheral Neuropathy
• Peripheral Nervous System Diseases

• NCT number: NCT04888988
• Study type: Interventional
• Source: University of Rochester
• Contact: Dee Murray, MS
• Phone: 585.275.6303
• Email: URCC_19075@URMC.Rochester.edu
• Status: Recruiting
• Phase: Phase 2
• Start date: February 25, 2022
• Completion date: January 2, 2026