Testing the Effects of Exercise on Chemotherapy-Induced Peripheral Neuropathy

Last updated: May 2, 2025
Sponsor: University of Rochester NCORP Research Base
Overall Status: Active - Recruiting

Phase

2

Condition

Neoplasms

Neurologic Disorders

Treatment

Brain Magnetic Resonance Imaging

Questionnaire Administration

Best Practice

Clinical Study ID

NCT04888988
URCC19075
UG1CA189961
URCC-19075
NCI-2020-11456
R21CA256154
URCC19075
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have a diagnosis of cancer

  • Have received neurotoxic chemotherapy within the past nine months (could still be onchemotherapy or have already completed chemotherapy; i.e., taxane-, platinum-, vincaalkaloid-, epothilone-, or proteasome inhibitor-based chemotherapy

  • Report one or more symptoms of CIPN at a level of >= 4 on the CIPN symptom inventoryon the Screening Form

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

  • Have at least six months life expectancy

  • Be at least 18 years of age

  • Be able to read and understand English

  • Be able to provide written informed consent

Exclusion

Exclusion Criteria:

  • Have physical limitations (e.g., cardiorespiratory, orthopedic, central nervoussystem) that contraindicate participation in a low to moderate intensity home-basedwalking and progressive resistance exercise program, according to the participant'sphysician (e.g., oncologist, primary care) or physician's designee

  • Be identified as in the active or maintenance stage of exercise behavior per theExercise Stages of Change Question on the Screening Form

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

  • Have contraindications for MRI scanning, per the MRI safety screening procedures ofthe MRI facility to be utilized for this participant

  • Are pregnant of have plans to become pregnant during the course of the study.Documentation of pregnancy and use of contraception can be obtained from the medicalrecord.

  • Have a current or prior cancer in the central nervous system (spine, brainstem,brain) as this would interfere with assessments of brain functional connectivity.

Study Design

Total Participants: 132
Treatment Group(s): 9
Primary Treatment: Brain Magnetic Resonance Imaging
Phase: 2
Study Start date:
February 25, 2022
Estimated Completion Date:
July 03, 2025

Study Description

PRIMARY OBJECTIVE:

I. Assess the preliminary efficacy of exercise versus (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 two possible CIPN mechanisms, namely interoception (via Multidimensional Assessment of Interoceptive Awareness version 2 [MAIA-2] questionnaire).

EXPLORATORY OBJECTIVES:

I. Assess the effects of exercise vs. standard care on other common symptoms related to cancer, chemotherapy, and CIPN, including:

Ia. Daily Diary of symptoms of CIPN. Ib. An array of cancer and treatment symptoms (MD Anderson Symptom Inventory; MDASI).

Ic. Anxiety and depression (hospital anxiety and depression scale; HADS). Id. Pain catastrophizing (pain catastrophizing scale; PCS). Ie. Cognitive impairment (Functional Assessment of Cancer Therapy-Cognitive [FACT-Cog]).

If. Fatigue (brief fatigue inventory; BFI). Ig. Quality of life (Functional Assessment of Cancer Therapy - General [FACT-G]).

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM 1 (EXERCISE): Participants undergo the exercise for cancer patients (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.

ARM 2 (CONTROL): 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 magnetic resonance imaging (MRI) on study.

Connect with a study center

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