Acupuncture for Chemotherapy-induced Peripheral Neuropathy

July 16, 2013 updated by: Pusan National University Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 602-739
        • Recruiting
        • Department of Hematology-Oncology and Center for Integrative Medicine, Pusan National University Hospital
        • Contact:
        • Principal Investigator:
          • Ho-Jin Shin, MD, PhD
        • Sub-Investigator:
          • Chang Woo Han, PhD
        • Sub-Investigator:
          • Eui-Hyoung Hwang, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acupuncture
Acupuncture treatment
Procedure: Acupuncture
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.
No Intervention: Control
No other active treatment or sham acupuncture for this symptoms

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Change of VAS (Visual Analogue Scale) from baseline
Time Frame: At baseline, 1, 2, 3, and 7 wks 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
Time Frame: At baseline, 1, 2, 3, and 7 wks from baseline
At baseline, 1, 2, 3, and 7 wks from baseline
Adverse events
Time Frame: From study enrollment to the last follow-up (up to 7 wks)
From study enrollment to the last follow-up (up to 7 wks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pusan National University Hospital

Investigators

  • Principal Investigator: Ho-Jin Shin, PhD, Pusan National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Anticipated)

April 1, 2014

Study Completion (Anticipated)

April 1, 2014

Study Registration Dates

First Submitted

June 18, 2013

First Submitted That Met QC Criteria

July 1, 2013

First Posted (Estimate)

July 4, 2013

Study Record Updates

Last Update Posted (Estimate)

July 17, 2013

Last Update Submitted That Met QC Criteria

July 16, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AcuCIPN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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