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Acupuncture for Chemo-Induced Peripheral Neuropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00891618
Recruitment Status : Completed
First Posted : May 1, 2009
Results First Posted : October 31, 2016
Last Update Posted : October 31, 2016
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
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 or disease Intervention/treatment Phase
Lymphoma Myeloma Peripheral Neuropathy Other: Acupuncture Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acupuncture for Chemo-induced Peripheral Neuropathy in Multiple Myeloma and Lymphoma Patients
Study Start Date : April 2009
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Mean Neuropathy Severity Score (FACT-GOG-Ntx Total Score Assessment) [ Time Frame: Baseline to Week 13. Assessments at baseline, once per week during the two treatment phases of the study, and one month (week 13) after the last acupuncture treatment. ]
    Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Neurotoxicity Scale (FACT/GOG-Ntx) Version 4 used to assess efficacy of acupuncture for treatment-induced peripheral neuropathy among multiple myeloma and/or lymphoma patients. Severity of neuropathy measured by FACT-GOG-Ntx total score assessment where 11-item questionnaire 5 point rating scale (0="not at all" and 4=equals "very much"). FACT/GOG-Ntx Total Score ranges from 0 (best possible outcome) to 44 (worst possible outcome).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 scale 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.)
  4. The patient's previous chemotherapy treatment must have included thalidomide and/or bortezomib and/or any derivatives.
  5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2.
  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. White Blood Counts (WBCs) < 3.0 K/UL.
  8. Active central nervous system (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 peripheral neuropathy (PN). Note: Minor adjustments in current medications at the time of enrollment is allowed.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00891618

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United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Millennium Pharmaceuticals, Inc.
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Principal Investigator: Michael Wang, MD, BS UT MD Anderson Cancer Center
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00891618    
Other Study ID Numbers: 2006-0679
First Posted: May 1, 2009    Key Record Dates
Results First Posted: October 31, 2016
Last Update Posted: October 31, 2016
Last Verified: September 2016
Keywords provided by M.D. Anderson Cancer Center:
Multiple Myeloma
Non-Hodgkin's Lymphoma
Treatment-induced Peripheral Neuropathy
Peripheral Neuropathy
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Peripheral Nervous System Diseases
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Neuromuscular Diseases
Nervous System Diseases