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


N/A
19 Years
N/A
Not Enrolling
Both
Peripheral Nervous System Disorders, Breast Neoplasms, Chemotherapy

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Outcome Measure:

effect size for reduction of neuropathic symptoms

Outcome Time Frame:

Baseline, 4, 8 12, 24 weeks

Safety Issue:

No

Principal Investigator

Constance Visovsky, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Nebraska

Authority:

United States: Institutional Review Board

Study ID:

478-08-FB

NCT ID:

NCT00869804

Start Date:

April 2009

Completion Date:

June 2011

Related Keywords:

  • Peripheral Nervous System Disorders
  • Breast Neoplasms
  • Chemotherapy
  • breast cancer
  • chemotherapy-induced peripheral neuropathy
  • exercise
  • Breast Neoplasms
  • Neoplasms
  • Nervous System Diseases
  • Peripheral Nervous System Diseases

Name

Location
University of Nebraska Medical Center Omaha, Nebraska  68198-3330