- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00869804
Heading Off Peripheral Neuropathy With Exercise (HOPE)
Pilot Randomized Study of Aerobic and Resistance Exercise for Women Undergoing Treatment for Breast Cancer With Taxanes.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Nebraska
-
Omaha, Nebraska, United States, 68198
- University of Nebraska Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exercise
combination aerobic (walking) and resistance (strength training) exercise
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
effect size for reduction of neuropathic symptoms
Time Frame: Baseline, 4, 8 12, 24 weeks
|
effect size for reduction of neuropathic symptoms
|
Baseline, 4, 8 12, 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
effect size for potential covariates on measures of chemotherapy-induced peripheral neuropathy
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
|
Baseline, 4, 8, 12, 24 weeks
|
feasibility and acceptability of a home-based aerobic and strength training exercise program
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.
|
Baseline, 4, 8, 12, 24 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Constance Visovsky, PhD, University of Nebraska
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0478-08-FB
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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