Acupuncture for Chemo-Induced Peripheral Neuropathy
Condition: Lymphoma; Myeloma; Peripheral Neuropathy
MeSH terms: Lymphoma; Multiple Myeloma; Neoplasms, Plasma Cell; Peripheral Nervous System Diseases
Intervention: Acupuncture
Intervention description: 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lymphoma; Myeloma; Multiple Myeloma; MM; Non-Hodgkin's Lymphoma; NHL; Acupuncture; Treatment-induced Peripheral Neuropathy; Thalidomide; Bortezomib; Neuropathy; Peripheral Neuropathy

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.
    

Eligibility 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 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.