Acupuncture for Chemotherapy-induced Peripheral Neuropathy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate whether acupuncture can be effective for chemotherapy-induced peripheral neuropathy in lymphoma or multiple myeloma patients.

Official Title
-----------------
Acupuncture Therapy for Chemotherapy-induced Peripheral Neuropathy in Lymphoma or Multiple Myeloma Patients: a Pilot Study

Conditions
-----------------
Peripheral Neuropathy, Toxicity Due to Chemotherapy, Lymphoma, Multiple Myeloma

Intervention / Treatment
-----------------
* Procedure: Acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years of age and have diagnosis of a lymphoma or multiple myeloma. Patients must have chemotherapy-induced peripheral neuropathy greater or equal to 2 according to CTCAE (Common Terminology Criteria for Adverse Events) v 3.0 scale (Appendix A) in spite of previous conventional medications, e.g. Neurontin, Cymbalta and/or Lyrica. Patients receiving any of conventional medication for this symptoms must remain on the same medications throughout the study period. Patients, or the legal guardians of patients, must have the ability to understand Korean, and be ble to provide informed consent. ECOG (Eastern Cooperative Oncology Group) Performance Status of 0, 1, or 2. If the patient is a woman of child-bearing potential, she must have a negative urine pregnancy test and agree to use contraception. Exclusion Criteria: Other diseases that, in the opinion of the investigators, can cause peripheral neuropathy, such as alcoholism, diabetes mellitus, and HIV. Current active treatment for lymphoma or multiple myeloma Ongoing local infection at or near the acupuncture point adopted in this trial. Severe immunocompromised patients, leukopenia ( < 4,000/㎣) or neutropenia ( < 1,500/㎣) Known coagulopathy, thrombocytopenia (< 50,000/㎣), and taking heparin (including low molecular weight heparin) or Coumadin at any dose. Serious emotional or mental problems that precludes study entry. Mental and physical disability that precludes accurate acupuncture. Serious systemic diseases such as active infection, severe heart disease, uncontrolled hypertension and diabetes mellitus. Cardiac pacemaker. Pregnant or breastfeeding Acupuncture therapy within the previous 30 days Concurrent other complementary and alternative therapy such as herbal agents, high dose vitamins, and etc.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture<br>Acupuncture treatment | Procedure: Acupuncture<br>* Acupuncture treatment will be performed by licensed doctors in Traditional Korean Medicine using 0.20 mm (diameter) X 0.40 mm (length) sized disposable acupuncture 3 times per week for 3 weeks. Acupuncture points are GV20, GB20 (bilateral), LI11 (bilateral), LI10 (bilateral), EX-UE9 (bilateral), ST36 (bilateral), ST40 (bilateral), and EX-LE10 (bilateral). Each session lasts 20-30 minutes.<br>|
| No Intervention: Control<br>No other active treatment or sham acupuncture for this symptoms | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of NCIC-CTC (National Cancer Institute of Canada - Common Toxicity Criteria) 4.0 scale from baseline |  | At baseline, 1, 2, 3, and 7 wks from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of VAS (Visual Analogue Scale) from baseline |  | At baseline, 1, 2, 3, and 7 wks from baseline | 
| Change of FACT/GOG-Ntx (Functional Assessment of Cancer Therapy/Gynecologic Oncology Group Neurotoxicity) from baseline |  | At baseline, 1, 2, 3, and 7 wks from baseline | 
| Adverse events |  | From study enrollment to the last follow-up (up to 7 wks) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acupuncture, Traditional Korean Medicine