Overview
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.
Eligibility
Inclusion Criteria:
- Have a diagnosis of cancer.
- 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).
- Report one or more symptoms of CIPN at a level of ≥4 on the CIPN symptom inventory on the Screening Form.
- Have an 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 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).
Additional exclusion criteria only for patients completing optional brain MRI scans
- Have contraindications for MRI scanning, per the MRI safety screening procedures of the MRI facility to be utilized for this participant.
- 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.
- Have a current or prior cancer in the central nervous system (spine, brainstem, brain) as this would interfere with assessments of brain functional connectivity.