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Acupuncture for Chemotherapy-induced Peripheral Neuropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01892852
Recruitment Status : Unknown
Verified July 2013 by Pusan National University Hospital.
Recruitment status was:  Recruiting
First Posted : July 4, 2013
Last Update Posted : July 17, 2013
Information provided by (Responsible Party):
Pusan National University Hospital

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.

Condition or disease Intervention/treatment Phase
Peripheral Neuropathy Toxicity Due to Chemotherapy Lymphoma Multiple Myeloma Procedure: Acupuncture Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acupuncture Therapy for Chemotherapy-induced Peripheral Neuropathy in Lymphoma or Multiple Myeloma Patients: a Pilot Study
Study Start Date : June 2013
Estimated Primary Completion Date : April 2014
Estimated Study Completion Date : April 2014

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

Primary Outcome Measures :
  1. 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 ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT01892852

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Contact: Chang Woo Han, PhD +82-51-240-6835

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Korea, Republic of
Department of Hematology-Oncology and Center for Integrative Medicine, Pusan National University Hospital Recruiting
Busan, Korea, Republic of, 602-739
Contact: Chang Woo Han, PhD    +82-51-240-6835   
Principal Investigator: Ho-Jin Shin, MD, PhD         
Sub-Investigator: Chang Woo Han, PhD         
Sub-Investigator: Eui-Hyoung Hwang, PhD         
Sponsors and Collaborators
Pusan National University Hospital
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Principal Investigator: Ho-Jin Shin, PhD Pusan National University Hospital
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Responsible Party: Pusan National University Hospital Identifier: NCT01892852    
Other Study ID Numbers: AcuCIPN
First Posted: July 4, 2013    Key Record Dates
Last Update Posted: July 17, 2013
Last Verified: July 2013
Keywords provided by Pusan National University Hospital:
Traditional Korean Medicine
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Peripheral Nervous System Diseases
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Neuromuscular Diseases
Nervous System Diseases