Heading Off Peripheral Neuropathy With Exercise

Not Applicable

Terminated

• Conditions: Breast Neoplasms; Chemotherapy; Peripheral Nervous System Disorders
• Interventions: Behavioral: Aerobic/ Resistance Exercise Intervention; Behavioral: Attention control

• Registration Number: NCT00869804
• Lead Sponsor: University of Nebraska

Brief Summary

Chemotherapy for the treatment of breast cancer can affect nerves and muscles leading to loss of sensation in the hands and feet for feeling hot and cold, difficulty walking, and muscle weakness. This study will explore if exercises such as walking and strength training may prove helpful in preventing or lessening chemotherapy-induced peripheral neuropathy from chemotherapy, making the therapy easier to tolerate and increasing overall quality of life.

Detailed Description

This pilot study will test the effects of a tailored home-based walking (aerobic) and strength training (resistance) exercise program for individuals receiving taxane-based chemotherapy for breast cancer on neuropathy, breast cancer-related symptoms, cold thermal sensation, vibratory sensation, gait \& balance, upper and lower extremity muscle strength, and quality of life.

The objective of this pilot study is to determine the effect size, feasibility and acceptability of a 12-week combination exercise program consisting of aerobic exercise (walking) and strength training for preventing or ameliorating the clinical manifestations and symptoms of CIPN in individuals with Stage I-IIIa non-metastatic breast cancer.

Study Timeline

• Study Start: 2009-03-25
• Study First Submitted: 2009-03-25
• Study First Submitted QC: 2009-03-25
• Study First Posted: 2009-03-26
• Primary Completion: 2011-12-13
• Study Completion: 2011-12-13
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-12-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• age 19 or older with newly diagnosed Stage I-IIIa invasive breast cancer who are to be treated with a taxane-based chemotherapy regimen (with paclitaxel or docetaxel) and thus are at risk for the development of CIPN.

Exclusion Criteria

• any disease (e.g. diabetes, HIV) that results in peripheral neuropathy;
• any disease or disorder that results in muscle weakness (such as chronic fatigue syndrome, multiple sclerosis, spinal cord tumors or injuries, stroke, preexisting cardiopulmonary disease);
• any disease or disorder that would preclude strength training exercises (such as bone metastasis, osteoporosis);
• individuals with diagnosed lymphedema or advanced disease (> Stage IIIa, or metastatic disease) at high risk for bone metastases and pathologic fracture will be excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise	Aerobic/ Resistance Exercise Intervention	combination aerobic (walking) and resistance (strength training) exercise
attention control	Attention control	attention control with daily journal and cancer-related education

Primary Outcome Measures

Name	Time	Method
effect size for reduction of neuropathic symptoms	Baseline, 4, 8 12, 24 weeks	effect size for reduction of neuropathic symptoms

Secondary Outcome Measures

Name	Time	Method
effect size for potential covariates on measures of chemotherapy-induced peripheral neuropathy	Baseline, 4, 8, 12, 24 weeks	effect size for potential covariates (age, taxane dose, baseline level of exercise participation, breast cancer-related symptoms) on measures of chemotherapy-induced peripheral neuropathy
feasibility and acceptability of a home-based aerobic and strength training exercise program	Baseline, 4, 8, 12, 24 weeks	determine the feasibility and acceptability of a home-based aerobic and strength training exercise program during and after taxane-based chemotherapy.

Trial Locations

Locations (1)

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States