CompletedNot Applicable

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

Canada61 participantsStarted 2014-12-01

Plain-language summary

The cause of Chemotherapy-Induced Peripheral Neuropathy (CIPN) is still unknown. An estimated 55-60% of patients will experience lasting symptoms affecting function for years post-treatment. Physical therapy is an established, effective treatment for entrapped nerves and neuropathic pain. This study sought to identify additional risk factors and provide evidence for the role of physical therapy in the treatment of CIPN.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Percentage of Participants With 'Pain' or 'no Pain' as Measured by the Numeric Pain Rating Scale

Timeframe: Regression models of pain reported over time (mid-docetaxel chemotherapy- 6 months post-chemotherapy). Mid-chemotherapy time frame participants were re-assessed after the 2 round of TC and 4th round of FECD.

Disability of the Arm, Shoulder and Hand (DASH)

Timeframe: administered on each re-assessment (pre-chemotherapy, mid-way through docetaxel chemotherapy, end of chemotherapy, 6 months post-chemotherapy) and mixed models accounted for all time points

Percentage of Participants With Neuropathic Pain Defined by the Self Report Version of Leeds Assessment for Neuropathic Symptoms and Signs (S-LANSS).

Timeframe: administered on each re-assessment (Visit 1 - pre-chemotherapy, Visit 2 - half-way through chemotherapy, Visit 3 - end of chemotherapy, Visit 4 - 3 months post-chemotherapy) and mixed models accounted for all time points

Trial details

NCT IDNCT02239601

SponsorCancerCare Manitoba

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-11-01

Results submitted2018-06-02

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