Testing the Effects of Exercise on Chemotherapy-Induced Peripheral Neuropathy

Summary

Participation Requirements

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...

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.

Tracking Information