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

NCT02239601 | Completed Results

• 1 other identifier: H2014:281
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; Peripheral Neuropathy, Secondary to Drugs or Chemicals

Keywords

Physical Therapy; Physiotherapy; Breast Cancer; Chemotherapy Induced Peripheral Neuropathy (CIPN); Nerve gliding exercises; Nerve Entrapment

Outcome Measures

Primary Outcomes (3)

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

  Numeric Pain Rating Scale - pain rating scale 0-10 (0= no pain to 10= most pain imaginable). Reported as percentages of participants with pain (1-10) vs no pain (0)

  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)

  A 30 item participant reported questionnaire commonly used to gauge upper limb function. Each item is scored 1-5 with 1 being 'no difficulty' and 5 being 'unable'. Overall score calculated as: \[average response (sum of responses divided by number of responses) -1\] x 25 to give a score out of 100. Minimum score is 30 with a maximum score of 150. The DASH was chosen because of high test-retest reliability and the responsiveness and construct validity in patients with breast cancer over other quality of life measures. A minimal clinical important difference is a change score of 15. Higher score indicates more impairment to the upper limb

  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).

  a 7 item patient reported questionnaire and was used to confirm the presence of neuropathic pain. The score ranges from 0-19 (no symptoms=0, sever symptoms=19) with a score above 12 indicative of neuropathic pain/symptoms. S-LANSS was chosen because of its' specificity and accuracy in a cancer population. Participants were requested to answer specifically for the hands, not feet.

  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

Secondary Outcomes (3)

• Vibration Sensory Analysis

  administered on each re-assessment (Visit 1 - pre-chemotherapy, Visit 2 - half-way through chemotherapy, Visit 3 - end of chemotherapy, Visit 4 - 6 months post-chemotherapy) and mixed models accounted for all time points

• Pain Pressure Thresholds

  administered on each re-assessment (Visit 1 - pre-chemotherapy, Visit 2 - half-way through chemotherapy, Visit 3 - end of chemotherapy, Visit 4 - 6 months post-chemotherapy) and mixed models accounted for all time points

• Grip Strength

  administered on each re-assessment (Visit 1 - pre-chemotherapy, Visit 2 - half-way through chemotherapy, Visit 3 - end of chemotherapy, Visit 4 - 6 months post-chemotherapy) and mixed models accounted for all time points

Study Arms (1)

Physical Therapy

EXPERIMENTAL

4 Physical therapy treatment sessions provided prior to chemotherapy and a home program to continue throughout the trial.

Other: Physical Therapy

Interventions

Physical Therapy OTHER

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 was provided and continued throughout chemotherapy treatment

Also known as: physiotherapy

Physical Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with stage I-III breast cancer undergoing regular docetaxel treatment either docetaxel-cyclophosphamide (TC) or 5FU-epirubicin-cyclophosphamide-docetaxel (FEC-D).

You may not qualify if:

• All patients must be able to communicate in english or be able to have a translator present at all appointments.
• 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.

Sponsors & Collaborators

• CancerCare Manitoba: lead
• University of Manitoba: collaborator

Study Sites (1)

Rehabilitation Hospital, Health Sciences Centre, 800 Sherbrook St

Winnipeg, Manitoba, R3A 1M4, Canada

Location

Related Publications (1)

• Andersen Hammond E, Pitz M, Steinfeld K, Lambert P, Shay B. An Exploratory Randomized Trial of Physical Therapy for the Treatment of Chemotherapy-Induced Peripheral Neuropathy. Neurorehabil Neural Repair. 2020 Mar;34(3):235-246. doi: 10.1177/1545968319899918. Epub 2020 Jan 24.

  PMID: 31976819 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Peripheral Nervous System Diseases; Nerve Compression Syndromes

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Results Point of Contact

• Title: Marshall Pitz
• Organization: CancerCare Manitoba

Mpitz@cc.umanitoba.ca

2044751431

Study Officials

• Barbara L Shay, PhD

  University of Manitoba

  STUDY DIRECTOR

• Elizabeth R Hammond, PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Oncologist and Associate Professor , University of Manitoba

Study Record Dates

• First Submitted: September 10, 2014
• First Posted: September 15, 2014
• Study Start: December 1, 2014
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: October 9, 2019
• Results First Posted: October 9, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)