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Physical Activity at Home for Relief from Neuropathy Caused by Taxanes in People with Breast Cancer

Clinicaltrials.gov identifier:
NCT04621721

Quality of Life
Quality of life study for breast cancer patients experiencing neuropathy from chemotherapy

Study Contact Information:

Contact: Constance Visovsky by phone: 813-974-3831 or by email: cvi[email protected] 
Contact: Jillian Coury by phone: 8139745117 or by email: [email protected] 

 


Study of Physical Activity at Home for Relief from Neuropathy Caused by Taxanes in People with Breast Cancer

About the Study

Chemotherapy-induced peripheral neuropathy (CIPN) symptoms include numbness combined with tingling sensations, persistent shooting, stabbing, or burning pain even in the absence of an obvious cause, lower extremity muscle weakness, and impaired balance. Resistance exercise has shown promising results; however, the effect of exercise on CIPN remains understudied. This study will look at the effects of gain and balance training and resistance exercise (using bands) on gait, balance, and lower extremity muscle strength after a 16-week home-based exercise program compared to educational materials without an exercise program.

What the Study Involves

Participants will be selected by chance to participate in one of the following groups:

  • 16-week Home-Based Physical Activity Intervention; This group will do a home-based gait/balance training and progressive resistance exercises for lower extremities using resistance power bands. 
  • Educational Attention control group; This group will receive an educational intervention via a journal in which to record their clinic appointments, and standardized American Cancer Society pamphlets.

Outcomes will be measured at the beginning of the study and at 16 weeks. Some outcomes are also measured at weeks 4, 8, and 12. Outcomes measured are gait change, balance change, change in lower extremity muscle strength, change in lower extremity nerve conduction, change in neuropathy symptoms, and neuropathy quality of life.

Study Sites

Florida
Tampa
University of South Florida
Contact: Constance Visovsky by phone: 813-974-3831 or by email: [email protected]   
Contact: Jillian Coury by phone: 8139745117 or by email: [email protected]   

 

 

 

This Study is Open To:

Female breast cancer survivors (>21) who completed treatment for invasive breast cancer with taxane-based chemotherapy, and who have a peripheral neuropathy (as rated based on a test known as a VAS score).

*contact your doctors or the study coordinators for questions about inclusion criteria.

 

This Study is Not Open To:

People with the following are not eligible:

  • Any disease (e.g. diabetes, HIV) that results in peripheral neuropathy or muscle weakness (such as chronic fatigue syndrome, multiple sclerosis, spinal cord tumors or injuries, stroke,); any disease that would preclude exercise (preexisting cardiopulmonary disease, bone ).
  • Individuals with  or advanced disease at high risk for bone metastases and pathologic fracture may not participate.

*contact your doctors or the study coordinators for questions about exclusion criteria.