Testing the Effects of Exercise on Chemotherapy-Induced Peripheral Neuropathy

Study Overview
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Brief Summary
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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
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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: IIIa. Interoception (via Multidimensional Assessment of Interoceptive Awareness version 2 [MAIA-2] questionnaire). IIIb. Inflammation (via serum cytokines IL6, IL-10, and IL-1beta, and prostaglandins PGF2alpha and 6-Keto PGF1 alpha). 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]), and coronavirus epidemic (coronavirus disease [COVID] effects). OUTLINE: Patients are randomized to 1 of 2 arms. ARM 1 (EXERCISE): Patients 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. Patients also undergo a tactile sensitivity test at baseline and after completion of EXCAP over 15-25 minutes. In addition, patients 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): Patients receive usual care for 6 weeks. At the end of the study, patients may receive the exercise kit and complete the EXCAP program as in Arm 1. Patients also undergo a tactile sensitivity test at baseline and after completion of EXCAP over 15-25 minutes.

Official Title
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Multi-Center Randomized Controlled Phase II Trial of Exercise to Treat Chemotherapy-Induced Peripheral Neuropathy (CIPN)

Conditions
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Chemotherapy-Induced Peripheral Neuropathy, Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm

Intervention / Treatment
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* Other: Exercise Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a diagnosis of cancer Be receiving neurotoxic chemotherapy or have completed neurotoxic chemotherapy in the past nine months (i.e., taxane-, platinum-, vinca alkaloid-, epothilone-, or proteasome inhibitor-based chemotherapy) Report two 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 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 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1 (EXCAP exercise)<br>Patients undergo the EXCAP exercise intervention consisting of a home-based, self-directed, individually tailored progressive walking and resistance program for up to 6 weeks. In addition, patients 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. | Other: Exercise Intervention<br>* Participate in the EXCAP exercise program (meeting with a counselor, receive follow-up meetings)<br>|
| No Intervention: Arm 2 (usual care)<br>Patients receive usual care for 6 weeks. At the end of the study, patients may receive the exercise kit and complete the EXCAP program as in Arm 1. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chemotherapy-induced peripheral neuropathy (CIPN) symptom severity | 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. | Week 6 post randomization |