Testing the Effects of Exercise on Chemotherapy-Induced Peripheral Neuropathy

  • STATUS
    Recruiting
  • End date
    Aug 1, 2025
  • participants needed
    120
  • sponsor
    University of Rochester NCORP Research Base
Updated on 21 April 2022
cancer

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.

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:

IIIa. Interoception (via Multidimensional Assessment of Interoceptive Awareness version 2 [MAIA-2] questionnaire).

IIIb. Inflammation (via serum cytokines IL6, IL-10, and IL-1beta, and prostaglandins PGF2alpha and 6-Keto PGF1 alpha).

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]), and coronavirus epidemic (coronavirus disease [COVID] effects).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM 1 (EXERCISE): Patients 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. Patients also undergo a tactile sensitivity test at baseline and after completion of EXCAP over 15-25 minutes. In addition, patients 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): Patients receive usual care for 6 weeks. At the end of the study, patients may receive the exercise kit and complete the EXCAP program as in Arm 1. Patients also undergo a tactile sensitivity test at baseline and after completion of EXCAP over 15-25 minutes.

Details
Condition Chemotherapy-Induced Peripheral Neuropathy, Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
Treatment exercise intervention
Clinical Study IdentifierNCT04888988
SponsorUniversity of Rochester NCORP Research Base
Last Modified on21 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Have a diagnosis of cancer
Be receiving neurotoxic chemotherapy or have completed neurotoxic chemotherapy in the past nine months (i.e., taxane-, platinum-, vinca alkaloid-, epothilone-, or proteasome inhibitor-based chemotherapy)
Report two or more symptoms of CIPN at a level of >= 4 on the CIPN symptom inventory on 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 Criteria

Have physical limitations (e.g., cardiorespiratory, orthopedic, central nervous system) that contraindicate participation in a low to moderate intensity home-based walking and progressive resistance program, according to the patient's physician (e.g., oncologist, primary care) or physician's designee
Be identified as in the active or maintenance stage of exercise behavior per the Exercise Stages of Change Question on the Screening Form
Have planned surgery or radiation treatment during the course of the study (hormonal and biologic therapy is allowed)
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