Breast Neoplasms, Chemotherapy, Peripheral Nervous System Disorders
Conditions
Keywords
breast cancer, chemotherapy-induced peripheral neuropathy, exercise
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.
Interventions
BEHAVIORALAerobic/ 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.
BEHAVIORALAttention control
Sponsors
University of Nebraska
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| effect size for reduction of neuropathic symptoms | Baseline, 4, 8 12, 24 weeks | effect size for reduction of neuropathic symptoms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| effect size for potential covariates on measures of chemotherapy-induced peripheral neuropathy | 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 |
| feasibility and acceptability of a home-based aerobic and strength training exercise program | 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. |
Countries
United States
Outcome results
None listed