Chemotherapy Induced Peripheral Neuropathy. Could Physical Therapy Help Treat Symptoms?
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02239601|
Recruitment Status : Completed
First Posted : September 15, 2014
Last Update Posted : January 26, 2018
The cause of Chemotherapy-Induced Peripheral Neuropathy (CIPN) is still unknown. A theory is that the microtubule-stabilizing agents that prevent division of cells also affect healthy peripheral nerves. Symptoms of CIPN are in the hands/feet and include: pain, numbness, and loss of function. An estimated 55-60% of patients will experience lasting symptoms affecting function for years post-treatment. Research on nerve disorders identifies that a nerve already entrapped/damaged at one site may be at greater risk when combined with chemotherapy (double crush syndrome). Physical therapy is an established, effective treatment for entrapped nerves and neuropathic pain. This study seeks to identify additional risk factors and provide evidence for the role of physical therapy in the treatment of CIPN.
- Physical therapy will assist in managing symptoms (sensory, pain, edema) compared to the control group during chemotherapy.
- Positive tests for mechanical entrapment prior to chemotherapy will result in more severe symptoms of CIPN.
- The treatment group will have greater resolution of CIPN symptoms compared to control at the six month follow-up.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Peripheral Neuropathy, Secondary to Drugs or Chemicals||Other: Physical Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pre-existing Nerve Entrapment as a Risk Factor for Chemotherapy - Induced Peripheral Neuropathy (CIPN). Could There be a Role for Physical Therapy Treatment?|
|Actual Study Start Date :||December 1, 2014|
|Actual Primary Completion Date :||November 1, 2017|
|Actual Study Completion Date :||November 2017|
Experimental: Physical Therapy
4 Physical therapy treatment sessions provided prior to chemotherapy and a home program to continue throughout the trial.
Other: Physical Therapy
Physical therapy assessment and treatment for any positive signs of nerve entrapment prior to chemotherapy including nerve gliding exercises, education and splinting. A home program will be provided to continue throughout chemotherapy treatment
Other Name: physiotherapy
- Change from baseline in Quantitative Sensory Testing [ Time Frame: Initial Assessment (enrolment pre-chemotherapy), 42 days (after the start of chemotherapy), Day 63, and Day 84 (only for patients still on chemotherapy). Follow-up at 3 and 6 months post chemotherapy treatment ]
These tests include:
Vibration thresholds and thermal detection (warm/cool) and pain thresholds (hot/cold) using Medoc Thermal Sensory Analyzer Light touch detection using Semmes Weinstein monofilaments Pain Pressure Algometry Grip strength testing
- Number of chemotherapy dose reductions or treatment delays due to severity of nerve pain from the chemotherapy induced neuropathy [ Time Frame: up to 2 years ]
- Change from baseline on self-report questionnaire of upper limb function ( Disabilities of the Shoulder, Arm and Hand DASH) [ Time Frame: Initial Assessment (enrolment pre-chemotherapy), 42 days (after the start of chemotherapy), Day 63, and Day 84 (only for patients still on chemotherapy). Follow-up at 3 and 6 months post chemotherapy treatment. ]
- Change from baseline for neuropathic pain measured by the Self reported Leeds Assessment Scale for Neuropathic Symptoms and SIgns (S-LANSS) [ Time Frame: Initial Assessment (enrolment pre-chemotherapy), 42 days (after the start of chemotherapy), Day 63, and Day 84 (only for patients still on chemotherapy). Follow-up at 3 and 6 months post chemotherapy treatment. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02239601
|Rehabilitation Hospital, Health Sciences Centre, 800 Sherbrook St|
|Winnipeg, Manitoba, Canada, R3A 1M4|
|Study Director:||Barbara L Shay, PhD||University of Manitoba|
|Principal Investigator:||Elizabeth R Hammond, PT, MSc.||University of Manitoba|