Heading Off Peripheral Neuropathy With Exercise (HOPE)

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University of Nebraska

Status

Terminated

Conditions

Chemotherapy
Peripheral Nervous System Disorders
Breast Neoplasms

Treatments

Behavioral: Aerobic/ Resistance Exercise Intervention
Behavioral: Attention control

Study type

Interventional

Funder types

Other

Identifiers

NCT00869804
0478-08-FB

Details and patient eligibility

About

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.

Full 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.

Enrollment

19 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

19 participants in 2 patient groups

Exercise
Experimental group
Description:
combination aerobic (walking) and resistance (strength training) exercise
Treatment:
Behavioral: Aerobic/ Resistance Exercise Intervention
attention control
Sham Comparator group
Description:
attention control with daily journal and cancer-related education
Treatment:
Behavioral: Attention control

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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