NCT01633281

Brief Summary

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

June 29, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 4, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

November 20, 2015

Status Verified

November 1, 2015

Enrollment Period

2 years

First QC Date

June 29, 2012

Last Update Submit

November 18, 2015

Conditions

Peripheral Neuropathy Grade 2 or Greater

Keywords

peripheral neuropathyacupunctureBortezomibThalidomide

Outcome Measures

Primary Outcomes (1)

  • Improvement in peripheral neuropathy

    within the 5 weeks of acupuncture treatment

Study Arms (1)

acupuncture treatment

EXPERIMENTAL
Procedure: acupuncture

Interventions

acupuncturePROCEDURE

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.

acupuncture treatment

Eligibility Criteria

Age21 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 21 years and have a diagnosis of a plasma cell dyscrasia or lymphoma.
  • 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.
  • \. The patient's current or previous treatment must include bortezomib or thalidomide
  • \. ECOG Performance Status of 0, 1, or 2

You may not qualify if:

  • 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.)
  • Thrombocytopenia (platelet counts \< 50x 109/L) on the day of acupuncture session
  • Deformities that could interfere with accurate acupuncture point location or out of energy pathway as defined by traditional acupuncture theory.
  • Concurrent use of anticoagulation agents.
  • 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.
  • Persistent absolute neutrophil counts of \< 1 x 109/L
  • Active CNS disease.
  • Patients having a cardiac pacemaker.
  • Currently pregnant or lactating females.
  • Severe diabetic neuropathy or neuropathy related to HIV.
  • Previous acupuncture treatment for any indication within 30 days of enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore General Hospital

Singapore, 169608, Singapore

Location

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Neuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Yeh-Ching Linn, MBBS, MRCP

    Singapore General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2012

First Posted

July 4, 2012

Study Start

June 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

November 20, 2015

Record last verified: 2015-11

Locations

SG(1)