Acupuncture for Chemo-Induced Peripheral Neuropathy

This study has been completed.
Sponsor:
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00891618
First received: April 30, 2009
Last updated: April 9, 2013
Last verified: April 2013
  Purpose

The goal of this clinical research study is to learn if giving acupuncture to patients with lymphoma or a plasma cell dyscrasia can help to relieve numbness and/or tingling of the feet and/or hands that is related to chemotherapy.


Condition Intervention Phase
Lymphoma
Myeloma
Peripheral Neuropathy
Other: 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: Acupuncture for Chemo-induced Peripheral Neuropathy in Multiple Myeloma and Lymphoma Patients

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

Enrollment: 27
Study Start Date: April 2009
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acupuncture
3 acupuncture sessions per week for 4 weeks (Weeks 1-4), 1 week off (Week 5), then 2 per week for 4 more weeks (Weeks 6-10), total of 20 sessions. Each session lasts 20-30 minutes.
Other: Acupuncture
3 acupuncture sessions per week for 4 weeks (Weeks 1-4), 1 week off (Week 5), then 2 per week for 4 more weeks (Weeks 6-10), total of 20 sessions. Each session lasts 20-30 minutes.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00891618

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Millennium Pharmaceuticals, Inc.
Investigators
Principal Investigator: Michael Wang, MD, BS UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00891618     History of Changes
Other Study ID Numbers: 2006-0679
Study First Received: April 30, 2009
Last Updated: April 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Lymphoma
Myeloma
Multiple Myeloma
MM
Non-Hodgkin's Lymphoma
NHL
Acupuncture
Treatment-induced Peripheral Neuropathy
Thalidomide
Bortezomib
Neuropathy
Peripheral Neuropathy

Additional relevant MeSH terms:
Lymphoma
Multiple Myeloma
Neoplasms, Plasma Cell
Peripheral Nervous System Diseases
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Neuromuscular Diseases
Nervous System Diseases
Signs and Symptoms
Poisoning
Substance-Related Disorders

ClinicalTrials.gov processed this record on April 15, 2014