Peripheral Neuropathy Grade 2 or Greater Clinical Trial
Official title:
A Study of Acupuncture for Bortezomib or Thalidomide -Induced Peripheral Neuropathy in Patients With Multiple Myeloma or Lymphoma
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.
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
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment