Active, currently enrolling
Multi-Center Randomized Controlled Phase II Trial of Exercise to Treat Chemotherapy-Induced Peripheral Neuropathy (CIPN)
NCT No.: NCT04888988
Study Type: INTERVENTIONAL
Phase:
Phase II
Region: California - Northern
Acronym:
Official Title
Multi-Center Randomized Controlled Phase II Trial of Exercise to Treat Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Purpose
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.
Detailed Description
Eligibility Criteria
Inclusion Criteria
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• 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
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Exclusion Criteria
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• 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.
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Keywords and/or Specific Medical Conditions
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- Peripheral Nervous System Diseases, Neuromuscular Diseases, Nervous System Diseases
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Sponsors
- University of Rochester NCORP Research Base
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