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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04888988
• Other study ID #: URCC19075
• Secondary ID: NCI-2020-11456UR
• Status: Recruiting
• Phase: Phase 2
• Start date: February 25, 2022
• Est. completion date: January 2, 2026

Study information

• Verified date: April 2024
• Source: University of Rochester
• Contact: Dee Murray, MS
• Phone: 585.275.6303
• Email: URCC_19075[@]URMC.Rochester.edu
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: January 2, 2026
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Have a diagnosis of cancer.

2. Have received an infusion of 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).

3. Report one or more symptoms of CIPN at a level of =4 on the CIPN symptom inventory on the Screening Form.

4. Have an ECOG Performance Status 0-1.

5. Have at least six months life expectancy.

6. Be at least 18 years of age.

7. Be able to read and understand English.

8. Be able to provide written informed consent.

Exclusion Criteria:

1. 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 patient's physician (e.g., oncologist, primary care) or physician's designee.

2. Be identified as in the active or maintenance stage of exercise behavior per the Exercise Stages of Change Question on the Screening Form.

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

Additional exclusion criteria only for patients completing optional brain MRI scans

4. Have contraindications for MRI scanning, per the MRI safety screening procedures of the MRI facility to be utilized for this participant.

5. Are pregnant or 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.

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

Related Conditions & MeSH terms

• Chemotherapy-Induced Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

Behavioral:
• Exercise Intervention
Participate in the Exercise for Cancer Patients (EXCAP) intervention

Other:
• Tactile Sensitivity Test
Participants undergo tactile sensitivity test
• Questionnaire Administration
Participants complete questionnaires

Procedure:
• Brain Magnetic Resonance Imaging
Participants may have options to complete brain MRI scans

Locations

Country	Name	City	State
United States	Chesapeake Regional Medical Center	Chesapeake	Virginia
United States	Mercy Hospital	Coon Rapids	Minnesota
United States	Dayton Clinical Oncology Program	Dayton	Ohio
United States	Cancer Care Specialists of Illinois	Decatur	Illinois
United States	Decatur Memorial Hospital	Decatur	Illinois
United States	Heartland NCORP	Decatur	Illinois
United States	Unity Hospital	Fridley	Minnesota
United States	Nash General Hospital	Rocky Mount	North Carolina
United States	Missouri Baptist Medical Center	Saint Louis	Missouri
United States	Park Nicollet Clinic - Saint Louis Park	Saint Louis Park	Minnesota
United States	Regions Hospital, Saint Paul	Saint Paul	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester NCORP Research Base	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chemotherapy-induced peripheral neuropathy (CIPN) symptom severity	Will estimate the effects of exercise versus usual care on CIPN (measured via CIPN-20) using analysis of covariance (ANCOVA). The model will include CIPN-20 at Week 6 as the outcome, treatment group (exercise vs. usual care) as the independent variable of interest, and the pre-intervention CIPN-20 score as a covariate.	Up to 6 weeks post randomization
Secondary	Effect of exercise on CIPN symptoms	We will conduct ANCOVA analyses to assess the effects of exercise versus usual care on each individual symptom of CIPN from the daily CIPN symptom inventory. The outcome for each symptom is the average of all 7 days of values at Week 6. The model will include each CIPN symptom at Week 6 as the outcome, treatment group (exercise vs. usual care) as the independent variable, and the pre-intervention CIPN symptom as a covariate.	Up to 6 weeks post randomization
Secondary	Effect of exercise on tactile sensitivity	We will conduct ANCOVA analyses to assess the effects of exercise on tactile sensitivity in the finger and tactile sensitivity in the toe from the touch test. The model will include tactile sensitivity in the finger at Week 6 as the outcome, treatment group (exercise vs. usual care) as the independent variable, and the pre-intervention tactile sensitivity in the finger as a covariate. The model will include tactile sensitivity in the toe at Week 6 as the outcome, treatment group (exercise vs. usual care) as the independent variable, and the pre-intervention tactile sensitivity in the toe as a covariate.	Up to 6 weeks post randomization
Secondary	Effect of exercise on interoception	We will conduct ANCOVA analyses to assess the effect of exercise on interoception (assessed via MAIA-2). The model will include MAIA-2 total score at Week 6 as the outcome, treatment group (exercise vs. usual care) as the independent variable of interest, and the pre-intervention MAIA-2 total score as a covariate.; *Optional We will use ANCOVA analyses to test for the effect of exercise on interception from brain fMRI. The outcome is insula-precuneus and insula-thalamus connectivity. The model will include insula-precuneus connectivity at Week 6 as the outcome, treatment group (exercise vs. usual care) as the independent variable, and the pre-intervention insula-precuneus connectivity as a covariate.; The model will include insula-thalamus connectivity at Week 6 as the outcome, treatment group (exercise vs. usual care) as the independent variable, and the pre-intervention insula-thalamus connectivity as a covariate.	Up to 6 weeks post randomization