Clinical trial NCT00869804: Heading Off Peripheral Neuropathy With Exercise
Official title: Pilot Randomized Study of Aerobic and Resistance Exercise for Women Undergoing Treatment for Breast Cancer With Taxanes.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Peripheral Nervous System Disorders
Breast Neoplasms
Chemotherapy
Keywords: breast cancer
chemotherapy-induced peripheral neuropathy
exercise
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2009-03-26
Enrollment: 19
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: effect size for reduction of neuropathic symptoms
timeFrame: Baseline, 4, 8 12, 24 weeks
Secondary outcomes:
measure: effect size for potential covariates on measures of chemotherapy-induced peripheral neuropathy
timeFrame: Baseline, 4, 8, 12, 24 weeks
measure: feasibility and acceptability of a home-based aerobic and strength training exercise program
timeFrame: Baseline, 4, 8, 12, 24 weeks
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Constance Visovsky, PhD
role: PRINCIPAL_INVESTIGATOR
References: