Pilot Randomized Study of Aerobic and Resistance Exercise for Women Undergoing Treatment for Breast Cancer With Taxanes.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- University of Nebraska
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- effect size for reduction of neuropathic symptoms
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
attention control
attention control with daily journal and cancer-related education
Intervention: Attention control (Behavioral)
Exercise
combination aerobic (walking) and resistance (strength training) exercise
Intervention: Aerobic/ Resistance Exercise Intervention (Behavioral)
Outcomes
Primary Outcomes
effect size for reduction of neuropathic symptoms
Time Frame: Baseline, 4, 8 12, 24 weeks
effect size for reduction of neuropathic symptoms
Secondary Outcomes
- effect size for potential covariates 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(Baseline, 4, 8, 12, 24 weeks)