Acupuncture for Chemo-Induced Peripheral Neuropathy

• Register: ClinicalTrials.gov
• Last refreshed on: 15 April 2013
• Main ID: NCT00891618
• Date of registration: 30/04/2009
• Primary sponsor: M.D. Anderson Cancer Center
• Public title: Acupuncture for Chemo-Induced Peripheral Neuropathy
• Scientific title: Acupuncture for Chemo-induced Peripheral Neuropathy in Multiple Myeloma and Lymphoma Patients
• Date of first enrolment: April 2009
• Target sample size: 27
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00891618
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Michael Wang, MD, BS
• Affiliation: UT MD Anderson Cancer Center

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Patients, or the legal guardians of patients, must have the ability to understand
English, sign a written informed consent document, and be willing to follow protocol
requirements.

2. Age > 18 years and have a diagnosis of a plasma cell dyscrasia or lymphoma.

3. Patients must have neuropathy greater or equal to 2 according to CTCAE v 3.0 scale
(Appendix A) in spite of previous treatment with Neurontin, Cymbalta and/or Lyrica.
Patients receiving any of these drugs must remain on the same medications throughout
the study period; however, minor adjustments in dosage are allowed. Patients will be
removed from the study if a change in type of medication is necessary. All patients
will receive treatment to both upper and lower extremities, regardless of whether or
not they are experiencing symptoms in all four extremities - see Section 7.0
Treatment Plan.)

4. The patient's previous chemotherapy treatment must have included thalidomide and/or
bortezomib and/or any derivatives.

5. ECOG Performance Status of 0, 1, or 2 (Appendix B).

6. 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:

1. Current active treatment with thalidomide and/or bortezomib.

2. 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
infection.)

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 other alternative medicines such as herbal agents, high dose
vitamins and anticoagulation agents.

5. Known coagulopathy and taking heparin (including low molecular weight heparin) or
Coumadin at any dose. Patients on aspirin or non-steroidal anti-inflammatories will
be allowed to participate.

6. Platelets < 50 H K/UL.

7. WBCs < 3.0 K/UL.

8. Active CNS disease. (The action for acupuncture may be associated with central
nervous system activity, and patients with CNS pathology may respond differently to
treatment than the general population.)

9. Cardiac pacemaker.

10. Mental incapacitation or significant emotional or psychological disorder that, in the
opinion of the investigators, precludes study entry. (These patients may not be able
to cooperate with this slightly invasive procedure or with the data collection
process.)

11. Currently pregnant or lactating females. (Certain acupuncture applications have been
reported to stimulate uterine contractions and may alter lactation.)

12. Chronic alcohol use as clinically estimated by the patient's physician.

13. History of diabetic neuropathy or neuropathy related to HIV.

14. Previous acupuncture treatment for any indication within 30 days of enrollment.

15. Active treatment for lymphoma, non-Hodgkin's lymphoma or multiple myeloma.

16. Planned or actual changes in type of medications that could affect symptoms related
to PN. Note: Minor adjustments in current medications at the time of enrollment is
allowed.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Lymphoma

Myeloma

Peripheral Neuropathy

Intervention(s)

Other: Acupuncture

Primary Outcome(s)

Neuropathy Severity (FACT-GOG-Ntx Total Score Assessment) [Time Frame: At baseline, once per week during two treatment phases of study, and one month (week 13) after last acupuncture treatment.]

Secondary ID(s)

2006-0679

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Millennium Pharmaceuticals, Inc.