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Chemotherapy Induced Peripheral Neuropathy. Could Physical Therapy Help Treat Symptoms?

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ClinicalTrials.gov Identifier: NCT02239601
Recruitment Status : Completed
First Posted : September 15, 2014
Last Update Posted : January 26, 2018
Sponsor:
Collaborator:
University of Manitoba
Information provided by (Responsible Party):
Dr. Marshall Pitz, CancerCare Manitoba

Brief Summary:

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.

Hypotheses

  1. Physical therapy will assist in managing symptoms (sensory, pain, edema) compared to the control group during chemotherapy.
  2. Positive tests for mechanical entrapment prior to chemotherapy will result in more severe symptoms of CIPN.
  3. 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. 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 ]
  2. 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. ]
  3. 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. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients diagnosed with stage I-III breast cancer undergoing regular docetaxel treatment either docetaxel-cyclophosphamide (TC) or 5FU-epirubicin-cyclophosphamide-docetaxel (FEC-D).
  • Patients that have not had chemotherapy in the past and do not have identified risk factors (listed below in the exclusion criteria).
  • All patients must be able to communicate in english or be able to have a translator present at all appointments.

Exclusion Criteria:

  • Patients diagnosed with stage IV breast cancer or who have co-morbid conditions that are known to cause peripheral neuropathic symptoms, including previous chemotherapy, exposure to toxins (such as lead), Diabetes, Shingles, B12 deficiency, Alcoholism, Lyme disease, Syphilis, HIV, Hereditary disorders such as Charcot-Marie Tooth.
  • Patients not planned to receive Docetaxel therapy.
  • Patients who cannot communicate in English and unable to bring an interpreter will also be excluded.

Information from the National Library of Medicine

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


Locations
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Canada, Manitoba
Rehabilitation Hospital, Health Sciences Centre, 800 Sherbrook St
Winnipeg, Manitoba, Canada, R3A 1M4
Sponsors and Collaborators
CancerCare Manitoba
University of Manitoba
Investigators
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Study Director: Barbara L Shay, PhD University of Manitoba
Principal Investigator: Elizabeth R Hammond, PT, MSc. University of Manitoba

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Responsible Party: Dr. Marshall Pitz, Medical Oncologist and Assistant Professor , University of Manitoba, CancerCare Manitoba
ClinicalTrials.gov Identifier: NCT02239601     History of Changes
Other Study ID Numbers: H2014:281
First Posted: September 15, 2014    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Dr. Marshall Pitz, CancerCare Manitoba:
Physical Therapy
Physiotherapy
Breast Cancer
Chemotherapy Induced Peripheral Neuropathy (CIPN)
Nerve gliding exercises
Nerve Entrapment

Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Nerve Compression Syndromes
Neuromuscular Diseases
Nervous System Diseases