Acupuncture for Peripheral Neuropathy
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.
Peripheral Neuropathy Grade 2 or Greater
|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|
- Improvement in peripheral neuropathy [ Time Frame: within the 5 weeks of acupuncture treatment ] [ Designated as safety issue: No ]
|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)|
|Experimental: acupuncture treatment||
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.
- The acupuncture treatment will start after patients have received at least 3 weeks of Gabapentin or Pregabalin at adequate dose without improvement in PN
- 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.
- 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.
- 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
|Singapore General Hospital||Recruiting|
|Singapore, Singapore, 169608|
|Contact: Joanna Huang 63214627 firstname.lastname@example.org|
|Principal Investigator: Yeh Ching Linn, MBBS, MRCP|
|Sub-Investigator: Daryl Tan, MBBS, MRCP|
|Sub-Investigator: Xiudi Qin|
|Principal Investigator:||Yeh-Ching Linn, MBBS, MRCP||Singapore General Hospital|