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Exercise for Peripheral Neuropathy

Phase 2

Recruiting

Led By Po-Ju Lin, PhD, MPH

Research Sponsored by University of Rochester NCORP Research Base

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be at least 18 years of age

Have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Must not have

Have planned surgery or radiation treatment during the course of the study (hormonal and biologic therapy is allowed)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 weeks post randomization

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare exercise to the usual approach for treating CIPN to see if it is more effective.

Who is the study for?

This trial is for adults with cancer who have nerve damage from chemotherapy, can understand English, and are expected to live at least six more months. They should be able to do some exercise and not have other health issues that make exercising unsafe. People who've had recent surgery or radiation (except hormone/biologic therapy) or already exercise regularly can't join.

What is being tested?

The study is looking at whether exercise helps people with nerve damage caused by chemotherapy better than the usual drug treatments. Participants will follow a home-based walking and resistance training program designed to see if it reduces their symptoms of neuropathy.

What are the potential side effects?

Since this trial involves an exercise intervention rather than medication, side effects may include typical responses to physical activity such as muscle soreness or fatigue. However, serious side effects are unlikely given the low-to-moderate intensity of the prescribed exercises.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I experience two or more symptoms of nerve damage from chemotherapy, rated 4 or higher.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not planning any surgery or radiation during the study, but hormone or biological treatments are okay.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 weeks post randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 weeks post randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 weeks post randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Chemotherapy-induced peripheral neuropathy (CIPN) symptom severity

Secondary study objectives

Effect of exercise on CIPN symptoms

Effect of exercise on interoception

Effect of exercise on tactile sensitivity

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm 1 Exercise Intervention- EXCAPExperimental Treatment4 Interventions

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.

Group II: Arm 2 Control condition (standard care)Active Control3 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Exercise Intervention

2016

Completed Phase 4

~1330

0 / 4Eligibility criteria met