Acupuncture for Chemotherapy-induced Peripheral Neuropathy

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Pusan National University Hospital
Sponsor:
Information provided by (Responsible Party):
Pusan National University Hospital
ClinicalTrials.gov Identifier:
NCT01892852
First received: June 18, 2013
Last updated: July 16, 2013
Last verified: July 2013
  Purpose

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 Intervention
Peripheral Neuropathy
Toxicity Due to Chemotherapy
Lymphoma
Multiple Myeloma
Procedure: Acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Acupuncture Therapy for Chemotherapy-induced Peripheral Neuropathy in Lymphoma or Multiple Myeloma Patients: a Pilot Study

Resource links provided by NLM:


Further study details as provided by Pusan National University Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change of VAS (Visual Analogue Scale) from baseline [ Time Frame: At baseline, 1, 2, 3, and 7 wks from baseline ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: From study enrollment to the last follow-up (up to 7 wks) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 36
Study Start Date: June 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01892852

Contacts
Contact: Chang Woo Han, PhD +82-51-240-6835 yeast10@hanmail.net

Locations
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    yeast10@hanmail.net   
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
Investigators
Principal Investigator: Ho-Jin Shin, PhD Pusan National University Hospital
  More Information

No publications provided

Responsible Party: Pusan National University Hospital
ClinicalTrials.gov Identifier: NCT01892852     History of Changes
Other Study ID Numbers: AcuCIPN
Study First Received: June 18, 2013
Last Updated: July 16, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by Pusan National University Hospital:
Acupuncture
Traditional Korean Medicine

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Lymphoma
Multiple Myeloma
Neoplasms, Plasma Cell
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Neuromuscular Diseases
Nervous System Diseases
Signs and Symptoms
Poisoning
Substance-Related Disorders

ClinicalTrials.gov processed this record on July 13, 2014