"Electro Acupuncture in the Treatment and Management of Chemotherapy Induced Peripheral Neuropathy"
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Acupuncture
Sham Acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Electroacupuncture, Neuropathic Pain, Chemotherapy Induced Peripheral Neuropathy
Eligibility 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
Sites / Locations
- University of ManitobaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Acupuncture
Sham Acupuncture
Arm Description
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).
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.
Outcomes
Primary Outcome Measures
S-Lanss (short- Leads assessment of neuropathic symptoms and signs)
16 point pain questionnaire that differentiates nociceptive from neuropathic pain
VAS (Visual Analogue Scale)
10 point verbal rating pain scale to measure participants pain in each assessment
DASH (Disabilities of the arm, shoulder, hand)
30 item questionnaire measuring upper limb function
LEFS (Lower extremity functional scale)
20 item questionnaire measuring lower limb function
Secondary Outcome Measures
Full Information
NCT ID
NCT02821442
First Posted
December 8, 2015
Last Updated
January 24, 2018
Sponsor
University of Manitoba
Collaborators
CancerCare Manitoba
1. Study Identification
Unique Protocol Identification Number
NCT02821442
Brief Title
"Electro Acupuncture in the Treatment and Management of Chemotherapy Induced Peripheral Neuropathy"
Official Title
"Electro Acupuncture in the Treatment and Management of Chemotherapy Induced Peripheral Neuropathy"
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
July 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba
Collaborators
CancerCare Manitoba
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Electroacupuncture, Neuropathic Pain, Chemotherapy Induced Peripheral Neuropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acupuncture
Arm Type
Experimental
Arm Description
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).
Arm Title
Sham Acupuncture
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Acupuncture
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Sham Acupuncture
Intervention Description
Placebo needles appear to penetrate but do not actually penetrate the skin
Primary Outcome Measure Information:
Title
S-Lanss (short- Leads assessment of neuropathic symptoms and signs)
Description
16 point pain questionnaire that differentiates nociceptive from neuropathic pain
Time Frame
2 years
Title
VAS (Visual Analogue Scale)
Description
10 point verbal rating pain scale to measure participants pain in each assessment
Time Frame
2 years
Title
DASH (Disabilities of the arm, shoulder, hand)
Description
30 item questionnaire measuring upper limb function
Time Frame
2 years
Title
LEFS (Lower extremity functional scale)
Description
20 item questionnaire measuring lower limb function
Time Frame
2 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth Hammond, M.Sc.
Phone
204-451-5702
Email
umande20@myumanitoba.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Barbara Shay, PhD
Phone
204-977-5636
Email
barbara.shay@med.umanitoba.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Shay, PhD
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0T6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Shay, PhD
Phone
204 977 5636
Email
Barbara.Shay@med.umanitoba.ca
First Name & Middle Initial & Last Name & Degree
Barbara L Shay, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
"Electro Acupuncture in the Treatment and Management of Chemotherapy Induced Peripheral Neuropathy"
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