Back to resultsHeading Off Peripheral Neuropathy With Exercise (HOPE)
Primary Purpose
Peripheral Nervous System Disorders, Breast Neoplasms, Chemotherapy
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aerobic/ Resistance Exercise Intervention
Attention control
Sponsored by
About this trial
This is an interventional supportive care trial for Peripheral Nervous System Disorders focused on measuring breast cancer, chemotherapy-induced peripheral neuropathy, exercise
Eligibility Criteria
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.
Sites / Locations
- University of Nebraska Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Exercise
attention control
Arm Description
combination aerobic (walking) and resistance (strength training) exercise
attention control with daily journal and cancer-related education
Outcomes
Primary Outcome Measures
effect size for reduction of neuropathic symptoms
Secondary Outcome Measures
effect size for potential covariates (age, taxane dose, baseline level of exercise participation, breast cancer-related symptoms) on measures of chemotherapy-induced peripheral neuropathy
determine the feasibility and acceptability of a home-based aerobic and strength training exercise program during and after taxane-based chemotherapy.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00869804
Brief Title
Heading Off Peripheral Neuropathy With Exercise
Acronym
HOPE
Official Title
Pilot Randomized Study of Aerobic and Resistance Exercise for Women Undergoing Treatment for Breast Cancer With Taxanes.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
Could not recruit total numbers needed. PI left institution.
Study Start Date
March 25, 2009 (Actual)
Primary Completion Date
December 13, 2011 (Actual)
Study Completion Date
December 13, 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Nervous System Disorders, Breast Neoplasms, Chemotherapy
Keywords
breast cancer, chemotherapy-induced peripheral neuropathy, exercise
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise
Arm Type
Experimental
Arm Description
combination aerobic (walking) and resistance (strength training) exercise
Arm Title
attention control
Arm Type
Sham Comparator
Arm Description
attention control with daily journal and cancer-related education
Intervention Type
Behavioral
Intervention Name(s)
Aerobic/ Resistance Exercise Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Attention control
Primary Outcome Measure Information:
Title
effect size for reduction of neuropathic symptoms
Time Frame
Baseline, 4, 8 12, 24 weeks
Secondary Outcome Measure Information:
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Constance Visovsky, PhD
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
12. IPD Sharing Statement
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