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"Electro Acupuncture in the Treatment and Management of Chemotherapy Induced Peripheral Neuropathy"

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ClinicalTrials.gov Identifier: NCT02821442
Recruitment Status : Recruiting
First Posted : July 1, 2016
Last Update Posted : January 26, 2018
Sponsor:
Collaborator:
CancerCare Manitoba
Information provided by (Responsible Party):
Barbara Shay, University of Manitoba

Brief Summary:
To evaluate the effectiveness of Electro acupuncture (EA) for treatment of persistent painful CIPN symptoms in patients with stages 1-3 breast cancer treated with docetaxel chemotherapy 6 months prior

Condition or disease Intervention/treatment Phase
Breast Cancer Device: Acupuncture Device: Sham Acupuncture Not Applicable

Detailed Description:

A double blind prospective randomized controlled pilot study with cross over.

To assess the effectiveness of EA in improving pain and function for chronic chemotherapy Induced Peripheral Neuropathy (CIPN) 30 participants will be recruited 6 months post-completion of chemotherapy. Fifteen participants will be randomized to the true EA group and 15 to the sham EA group. Those participants randomized to the sham group will cross over to receive true EA after the trial is complete.

Treatment consists of EA or sham EA 1 x per week x 6 weeks. Re-assessment visits occur after the 6 week intervention and again 2 months post trial.

Each assessment visit quantifies the sensory experience of CIPN at that moment in time using Quantitative Sensory Testing (QST) which includes; thermal detection and thermal pain thresholds, light touch detection using nylon monofilament hairs (Semmes Weinstein Monofilaments (SWMF)), static 2-point discrimination, pressure algometry and vibration thresholds. Patient reported outcome measures including the Disabilities of the Arm, Shoulder and Hand (DASH), Lower extremity functional score (LEFS), the Self report Leeds Assessment of Neuropathic signs and symptoms (S-LANSS) pain questionaire will also be used.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: "Electro Acupuncture in the Treatment and Management of Chemotherapy Induced Peripheral Neuropathy"
Study Start Date : February 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Acupuncture
Acupuncture will consist of acupuncture points ST36, LR3, LI4 bilaterally x 30 minutes, once a week over 6 weeks. ST36 will have EA with 2Hz at the maximum tolerated intensity (ES-130 Portable Japanese Electro-Acupuncture Device, UPC Medical Supplies Inc. South El Monte, CA, USA).
Device: Acupuncture
Acupuncture points selected on the arms and legs using both acupuncture and electroacupuncture to assess effectiveness in alleviating neuropathic pain caused by chemotherapy in breast cancer patients

Sham Comparator: Sham Acupuncture
Sham acupuncture (Streitberger Placebo Needles, Asiamed) uses the same points and treatment parameters but the placebo needle does not penetrate the skin and the current for EA is not turned on.
Device: Sham Acupuncture
Placebo needles appear to penetrate but do not actually penetrate the skin




Primary Outcome Measures :
  1. S-Lanss (short- Leads assessment of neuropathic symptoms and signs) [ Time Frame: 2 years ]
    16 point pain questionnaire that differentiates nociceptive from neuropathic pain

  2. VAS (Visual Analogue Scale) [ Time Frame: 2 years ]
    10 point verbal rating pain scale to measure participants pain in each assessment

  3. DASH (Disabilities of the arm, shoulder, hand) [ Time Frame: 2 years ]
    30 item questionnaire measuring upper limb function

  4. LEFS (Lower extremity functional scale) [ Time Frame: 2 years ]
    20 item questionnaire measuring lower limb function



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any patient diagnosed with stage 1-3 breast cancer who has finished chemotherapy 6 months prior and has residual CIPN symptoms graded as a 3/10 or higher on the numeric rating pain scale.

Exclusion Criteria:

  • Patients who have co-morbid conditions that cause peripheral neuropathic symptoms
  • patients with heart valve replacements
  • patients on prophylactic antibiotics
  • patients with severe coagulopathy
  • patients who did not receive regular taxane therapy

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): NCT02821442


Contacts
Contact: Elizabeth Hammond, M.Sc. 204-451-5702 umande20@myumanitoba.ca
Contact: Barbara Shay, PhD 204-977-5636 barbara.shay@med.umanitoba.ca

Locations
Canada, Manitoba
University of Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 0T6
Contact: Barbara Shay, PhD    204 977 5636    Barbara.Shay@med.umanitoba.ca   
Principal Investigator: Barbara L Shay, PhD         
Sponsors and Collaborators
University of Manitoba
CancerCare Manitoba
Investigators
Principal Investigator: Barbara Shay, PhD University of Manitoba

Responsible Party: Barbara Shay, Associate Professor, Department head, College of Rehabilitation Sciences, University of Manitoba
ClinicalTrials.gov Identifier: NCT02821442     History of Changes
Other Study ID Numbers: H2015:282
First Posted: July 1, 2016    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Barbara Shay, University of Manitoba:
Electroacupuncture
Neuropathic Pain
Chemotherapy Induced Peripheral Neuropathy

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases