Status:
ACTIVE_NOT_RECRUITING
Testing the Effects of Exercise on Chemotherapy-Induced Peripheral Neuropathy
Lead Sponsor:
University of Rochester NCORP Research Base
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Chemotherapy-Induced Peripheral Neuropathy
Hematopoietic and Lymphoid Cell Neoplasm
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 co...
Detailed 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 prelim...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2026
Estimated Enrollment :
133 Patients enrolled
Trial Details
Trial ID
NCT04888988
Start Date
February 25 2022
End Date
February 1 2026
Last Update
November 21 2025
Active Locations (93)
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1
Kaiser Permanente-Fresno
Fresno, California, United States, 93720
2
Contra Costa Regional Medical Center
Martinez, California, United States, 94553-3156
3
Kaiser Permanente-Roseville
Roseville, California, United States, 95661
4
Kaiser Permanente Downtown Commons
Sacramento, California, United States, 95814