Heading Off Peripheral Neuropathy With Exercise (HOPE)
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|ClinicalTrials.gov Identifier: NCT00869804|
Recruitment Status : Unknown
Verified March 2009 by University of Nebraska.
Recruitment status was: Not yet recruiting
First Posted : March 26, 2009
Last Update Posted : March 26, 2009
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Nervous System Disorders Breast Neoplasms Chemotherapy||Behavioral: Aerobic/ Resistance Exercise Intervention Behavioral: Attention control||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Pilot Randomized Study of Aerobic and Resistance Exercise for Women Undergoing Treatment for Breast Cancer With Taxanes.|
|Study Start Date :||April 2009|
|Estimated Primary Completion Date :||June 2011|
|Estimated Study Completion Date :||June 2011|
combination aerobic (walking) and resistance (strength training) exercise
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.
Sham Comparator: attention control
attention control with daily journal and cancer-related education
Behavioral: Attention control
- effect size for reduction of neuropathic symptoms [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: Baseline, 4, 8, 12, 24 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00869804
|Contact: Constance Visovsky, PhDfirstname.lastname@example.org|
|United States, Nebraska|
|University of Nebraska Medical Center||Not yet recruiting|
|Omaha, Nebraska, United States, 68198|
|Contact: Constance Visovsky, PhD 402-559-5468 email@example.com|
|Principal Investigator: Constance Visovsky, PhD|
|Principal Investigator:||Constance Visovsky, PhD||University of Nebraska|