Testing the Effects of Exercise on Chemotherapy-Induced Peripheral Neuropathy (CIPN)

University of Rochester NCORP Research Base

Status

Active, not recruiting

Conditions

Hematopoietic and Lymphoid Cell Neoplasm

Chemotherapy-Induced Peripheral Neuropathy

Malignant Solid Neoplasm

Treatments

Other: Exercise Intervention

Other: Neuropathy Assessment

Other: Best Practice

Other: Questionnaire Administration

Procedure: Magnetic Resonance Imaging

Other: Exercise Counseling

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT04888988

UG1CA189961 (U.S. NIH Grant/Contract)

NCI-2020-11456 (Registry Identifier)

URCC19075 (Other Identifier)

URCC-19075 (Other Identifier)

R21CA256154 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

133 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Have a diagnosis of cancer
Have received neurotoxic chemotherapy within the past nine months (could still be on chemotherapy or have already completed chemotherapy; i.e., taxane-, platinum-, vinca alkaloid-, epothilone-, or proteasome inhibitor-based chemotherapy
Report one 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 exercise program, according to the participant'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)
Have contraindications for MRI scanning, per the MRI safety screening procedures of the 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 medical record.
Have a current or prior cancer in the central nervous system (spine, brainstem, brain) as this would interfere with assessments of brain functional connectivity.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

133 participants in 2 patient groups

Arm 1 (EXCAP, tactile sensitivity test, counseling)

Experimental group

Description:

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.

Treatment:

Other: Exercise Counseling

Procedure: Magnetic Resonance Imaging

Other: Questionnaire Administration

Other: Neuropathy Assessment

Other: Exercise Intervention

Arm 2 (usual care, tactile sensitivity test)

Active Comparator group

Description:

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.

Treatment:

Other: Exercise Counseling

Procedure: Magnetic Resonance Imaging

Other: Questionnaire Administration

Other: Neuropathy Assessment

Other: Best Practice

Other: Exercise Intervention