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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: Acupuncture
* Device: Sham Acupuncture


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture<br>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<br>* 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<br>|
| Sham Comparator: Sham Acupuncture<br>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<br>* Placebo needles appear to penetrate but do not actually penetrate the skin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| S-Lanss (short- Leads assessment of neuropathic symptoms and signs) | 16 point pain questionnaire that differentiates nociceptive from neuropathic pain | 2 years | 
| VAS (Visual Analogue Scale) | 10 point verbal rating pain scale to measure participants pain in each assessment | 2 years | 
| DASH (Disabilities of the arm, shoulder, hand) | 30 item questionnaire measuring upper limb function | 2 years | 
| LEFS (Lower extremity functional scale) | 20 item questionnaire measuring lower limb function | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electroacupuncture, Neuropathic Pain, Chemotherapy Induced Peripheral Neuropathy