Testing the Effects of Exercise on Chemotherapy-Induced Peripheral Neuropathy
- Conditions
- Chemotherapy-Induced Peripheral NeuropathyHematopoietic and Lymphoid Cell NeoplasmMalignant Solid Neoplasm
- Registration Number
- NCT04888988
- Lead Sponsor
- University of Rochester NCORP Research Base
- 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 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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 132
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Chemotherapy-induced peripheral neuropathy (CIPN) symptom severity Week 6 post randomization Will estimate the effects of exercise versus usual care on CIPN using analysis of covariance (ANCOVA). Will be measured by the mean European Organization for Research and Treatment of Cancer-CIPN20. 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.
- Secondary Outcome Measures
Name Time Method Effects of exercise on the severity of CIPN symptoms Up to 6 weeks post randomization We will estimate the effects of exercise vs. usual care on CIPN symptoms (i.e., hot/burning or sharp/shooting pain in the hands or feet, numbness or tingling in the hands or feet) collected from the daily symptom inventory (0-10 severity) using analysis of covariance (ANCOVA). The model will include the average of daily symptom inventory for each CIPN symptom at post-intervention as the outcome, controlling for the average of daily symptom inventory for each CIPN symptom at pre-intervention.
Effects of exercise on tactile sensitivity Up to 6 weeks post randomization We will estimate the effects of exercise vs. usual care on tactile sensitivity in the fingers and toes, assessed via an established touch test procedure with a set of monofilaments, using analysis of covariance (ANCOVA). The model will include the tactile sensitivity score at post-intervention as the outcome, controlling for the pre-intervention score.
Effect of exercise on interoception Up to 6 weeks post randomization We will estimate the effects of exercise vs. usual care on interoception, measured via the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2), using analysis of covariance (ANCOVA). The model will include the MAIA-2 total score at post-intervention as the outcome, controlling for the pre-intervention MAIA-2 total score.
Trial Locations
- Locations (93)
Kaiser Permanente-Fresno
🇺🇸Fresno, California, United States
Contra Costa Regional Medical Center
🇺🇸Martinez, California, United States
Kaiser Permanente-Roseville
🇺🇸Roseville, California, United States
Kaiser Permanente Downtown Commons
🇺🇸Sacramento, California, United States
Kaiser Permanente-South Sacramento
🇺🇸Sacramento, California, United States
Kaiser Permanente-Santa Teresa-San Jose
🇺🇸San Jose, California, United States
Kaiser Permanente San Leandro
🇺🇸San Leandro, California, United States
Kaiser San Rafael-Gallinas
🇺🇸San Rafael, California, United States
Kaiser Permanente Medical Center - Santa Clara
🇺🇸Santa Clara, California, United States
Kaiser Permanente-South San Francisco
🇺🇸South San Francisco, California, United States
Scroll for more (83 remaining)Kaiser Permanente-Fresno🇺🇸Fresno, California, United States