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Acupuncture for Chemotherapy-induced Peripheral Neuropathy

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ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
Pusan National University Hospital

Tracking Information
First Submitted Date  ICMJE June 18, 2013
First Posted Date  ICMJE July 4, 2013
Last Update Posted Date July 17, 2013
Study Start Date  ICMJE June 2013
Estimated Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2013)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 1, 2013)
Change of NCIC-CTC (National Cancer Institute Common Toxicity Criteria) 4.0 scale from baseline [ Time Frame: At baseline, 1, 2, 3, and 7 wks from baseline ]
Change History Complete list of historical versions of study NCT01892852 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2013)
  • Change of VAS (Visual Analogue Scale) from baseline [ Time Frame: 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 ]
  • Adverse events [ Time Frame: From study enrollment to the last follow-up (up to 7 wks) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acupuncture for Chemotherapy-induced Peripheral Neuropathy
Official Title  ICMJE Acupuncture Therapy for Chemotherapy-induced Peripheral Neuropathy in Lymphoma or Multiple Myeloma Patients: a Pilot Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Peripheral Neuropathy
  • Toxicity Due to Chemotherapy
  • Lymphoma
  • Multiple Myeloma
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Acupuncture
    Acupuncture treatment
    Intervention: Procedure: Acupuncture
  • No Intervention: Control
    No other active treatment or sham acupuncture for this symptoms
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 1, 2013)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2014
Estimated Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01892852
Other Study ID Numbers  ICMJE AcuCIPN
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pusan National University Hospital
Study Sponsor  ICMJE Pusan National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ho-Jin Shin, PhD Pusan National University Hospital
PRS Account Pusan National University Hospital
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP