Acupuncture for Peripheral Neuropathy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Singapore General Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Neuroscience Institute
Information provided by (Responsible Party):
Singapore General Hospital
ClinicalTrials.gov Identifier:
NCT01633281
First received: June 29, 2012
Last updated: July 4, 2012
Last verified: June 2012
  Purpose

A significant proportion (up to 60%) of myeloma patients treated with Bortezomib or thalidomide or both develop significant peripheral neuropathy (PN). Standard of care for this complication include drugs like gabapentin or pregabalin, which relieve symptoms only partially. PN of grade II or above mandates reduction in dose or frequency of Bortezomib or thalidomide, which may compromise treatment outcome. This clinical study explores whether, by intervening early in its course using acupuncture, progression of PN can be reversed, stabilized or retarded thereby allowing continuation of treatment on schedule.


Condition Intervention Phase
Peripheral Neuropathy Grade 2 or Greater
Procedure: acupuncture
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study of Acupuncture for Bortezomib or Thalidomide -Induced Peripheral Neuropathy in Patients With Multiple Myeloma or Lymphoma

Resource links provided by NLM:


Further study details as provided by Singapore General Hospital:

Primary Outcome Measures:
  • Improvement in peripheral neuropathy [ Time Frame: within the 5 weeks of acupuncture treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: June 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: acupuncture treatment Procedure: acupuncture
Ten sessions of acupuncture at 2x per week over 5 weeks will be given to patients. The acupuncture points include a standard set of obligatory points and additional points based on symptoms.

Detailed Description:
  1. The acupuncture treatment will start after patients have received at least 3 weeks of Gabapentin or Pregabalin at adequate dose without improvement in PN
  2. Two sessions of acupuncture per week, each of 30minutes duration, will be administered for a total of 10 sessions over 5 weeks. The needling will be done by the designated acupuncturist for all patients, delivered with electrical stimulation at a defined frequency.
  3. A fixed set of acupoints will be applied which include both local and distant points, based on both symptoms of PN and classification of TCM syndrome. Some degree of flexibility with addition or reduction of acupoints is allowed based on clinical indication. The acupoints needled each session will be recorded.
  4. Assessment of efficacy 4.1 Objective response : A complete neurological examination will be done at commencement of acupuncture and at end of acupuncture.

In addition, a full nerve conduction test will be done at beginning of acupuncture and at the end of 10 sessions of acupuncture.

4.2 Subjective assessment A quality of life questionnaire (FACT/GOG-NTX v4) will be filled in by patients at enrolment, commencement, at the 6th session and at the end of 10 sessions of acupuncture.

4.3 Scoring With both objective and subjective assessment, a Total Neuropathy Score can be calculated at each time point as a quantitative measurement of the severity of PN

5. Statistical considerations The statistical analysis specifies that a lower limit of the two-sided 90 percent confidence interval for the overall positive response that exceeded 10 percent would be considered to be evidence of significant efficacy of acupuncture in retarding Bortezomib or thalidomide induced PN. Allowing a confidence interval width of 30%, the sample size needed will be 34 patients. To allow for a 10% drop-out, we plan to recruit a total of 40 patients

  Eligibility

Ages Eligible for Study:   21 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age > 21 years and have a diagnosis of a plasma cell dyscrasia or lymphoma.
  2. Patients must have neuropathy greater or equal to 2 according to CTCAE v 3.0 scale in spite of adequate duration (at least 3 weeks) of previous treatment with Gabapentin or Pregabalin or are unable to tolerate these drugs. Patients receiving any of these drugs must remain on the same medications throughout the study period; however, minor adjustments in dosage are allowed.

3. The patient's current or previous treatment must include bortezomib or thalidomide

4. ECOG Performance Status of 0, 1, or 2

Exclusion Criteria:

  1. Local infection at or near the acupuncture site. (Although acupuncture is a minimally invasive procedure, patients will be excluded if there is an indication of active infection.)
  2. Thrombocytopenia (platelet counts < 50x 109/L) on the day of acupuncture session
  3. Deformities that could interfere with accurate acupuncture point location or out of energy pathway as defined by traditional acupuncture theory.
  4. Concurrent use of anticoagulation agents.
  5. Known coagulopathy and taking heparin (including low molecular weight heparin) or warfarin at any dose. Patients on aspirin or non-steroidal anti-inflammatories are allowed to participate.
  6. Persistent absolute neutrophil counts of < 1 x 109/L
  7. Active CNS disease.
  8. Patients having a cardiac pacemaker.
  9. Currently pregnant or lactating females.
  10. Severe diabetic neuropathy or neuropathy related to HIV.
  11. Previous acupuncture treatment for any indication within 30 days of enrollment.
  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: NCT01633281

Locations
Singapore
Singapore General Hospital Recruiting
Singapore, Singapore, 169608
Contact: Joanna Huang    63214627    huang.wanyan@sgh.com.sg   
Principal Investigator: Yeh Ching Linn, MBBS, MRCP         
Sub-Investigator: Daryl Tan, MBBS, MRCP         
Sub-Investigator: Xiudi Qin         
Sponsors and Collaborators
Singapore General Hospital
National Neuroscience Institute
Investigators
Principal Investigator: Yeh-Ching Linn, MBBS, MRCP Singapore General Hospital
  More Information

No publications provided

Responsible Party: Singapore General Hospital
ClinicalTrials.gov Identifier: NCT01633281     History of Changes
Other Study ID Numbers: Acupuncture 001
Study First Received: June 29, 2012
Last Updated: July 4, 2012
Health Authority: Singapore: Domain Specific Review Boards

Keywords provided by Singapore General Hospital:
peripheral neuropathy
acupuncture
Bortezomib
Thalidomide

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 18, 2014