Heading Off Peripheral Neuropathy With Exercise

Breast Neoplasms Clinical Trial

— HOPE  

Official title:

Pilot Randomized Study of Aerobic and Resistance Exercise for Women Undergoing Treatment for Breast Cancer With Taxanes.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00869804
• Other study ID #: 0478-08-FB
• Status: Terminated
• Phase: N/A
• Start date: March 25, 2009
• Est. completion date: December 13, 2011

Study information

• Verified date: November 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: December 13, 2011
• Est. primary completion date: December 13, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Chemotherapy
• Nervous System Diseases
• Peripheral Nervous System Diseases
• Peripheral Nervous System Disorders

Intervention

Behavioral:
• Aerobic/ Resistance Exercise Intervention
The intervention will consist of a tailored home-based program of both aerobic (walking, using pedometer) and strength training exercises for upper and lower extremities using resistance power bands.
• Attention control

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

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