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Heading Off Peripheral Neuropathy With Exercise (HOPE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by University of Nebraska.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00869804
First received: March 25, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Peripheral Nervous System Disorders
Breast Neoplasms
Chemotherapy
 Behavioral: Aerobic/ Resistance Exercise Intervention
Behavioral: Attention control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • effect size for reduction of neuropathic symptoms [ Time Frame: Baseline, 4, 8 12, 24 weeks ] [ Designated as safety issue: No ]

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 [ Time Frame: Baseline, 4, 8, 12, 24 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: April 2009
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise
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

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00869804

Contacts
Contact: Constance Visovsky, PhD 402-559-5468 cvisovsky@unmc.edu

Locations
United States, Nebraska
University of Nebraska Medical Center Not yet recruiting
Omaha, Nebraska, United States, 68198
Contact: Constance Visovsky, PhD     402-559-5468     cvisovsky@unmc.edu    
Principal Investigator: Constance Visovsky, PhD            
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Constance Visovsky, PhD University of Nebraska
  More Information

No publications provided

Responsible Party: Dr. Constance Visovsky, University of Nebraska Medical Center, College of Nursing
ClinicalTrials.gov Identifier: NCT00869804     History of Changes
Other Study ID Numbers: 478-08-FB
Study First Received: March 25, 2009
Last Updated: March 25, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
breast cancer
chemotherapy-induced peripheral neuropathy
exercise

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Nervous System Diseases
Peripheral Nervous System Diseases
 Neoplasms by Site
Breast Diseases
Skin Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on May 16, 2013