Acupuncture for Chemo-Induced Peripheral Neuropathy

NCT00891618 | Completed Phase 2 Results

• 1 other identifier: 2006-0679
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoma; Myeloma; Peripheral Neuropathy

Keywords

Lymphoma; Myeloma; Multiple Myeloma; MM; Non-Hodgkin's Lymphoma; NHL; Acupuncture; Treatment-induced Peripheral Neuropathy; Thalidomide; Bortezomib; Neuropathy; Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• Mean Neuropathy Severity Score (FACT-GOG-Ntx Total Score Assessment)

  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).

  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.

Study Arms (1)

Acupuncture

EXPERIMENTAL

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

Interventions

Acupuncture OTHER

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.

Acupuncture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Age \> 18 years and have a diagnosis of a plasma cell dyscrasia or lymphoma.
• 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.)
• The patient's previous chemotherapy treatment must have included thalidomide and/or bortezomib and/or any derivatives.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2.
• If the patient is a woman of child-bearing potential, she must have a negative urine pregnancy test and agree to use contraception.

You may not qualify if:

• Current active treatment with thalidomide and/or bortezomib.
• 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.)
• Deformities that could interfere with accurate acupuncture point location or out of energy pathway as defined by traditional acupuncture theory.
• Concurrent use of other alternative medicines such as herbal agents, high dose vitamins and anticoagulation agents.
• 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.
• Platelets \< 50 H K/UL.
• White Blood Counts (WBCs) \< 3.0 K/UL.
• 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.)
• Cardiac pacemaker.
• 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.)
• Currently pregnant or lactating females. (Certain acupuncture applications have been reported to stimulate uterine contractions and may alter lactation.)
• Chronic alcohol use as clinically estimated by the patient's physician.
• History of diabetic neuropathy or neuropathy related to HIV.
• Previous acupuncture treatment for any indication within 30 days of enrollment.
• Active treatment for lymphoma, non-Hodgkin's lymphoma or multiple myeloma.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Millennium Pharmaceuticals, Inc.: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Garcia MK, Cohen L, Guo Y, Zhou Y, You B, Chiang J, Orlowski RZ, Weber D, Shah J, Alexanian R, Thomas S, Romaguera J, Zhang L, Badillo M, Chen Y, Wei Q, Lee R, Delasalle K, Green V, Wang M. Electroacupuncture for thalidomide/bortezomib-induced peripheral neuropathy in multiple myeloma: a feasibility study. J Hematol Oncol. 2014 May 9;7:41. doi: 10.1186/1756-8722-7-41.

  PMID: 24886772 DERIVED

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Lymphoma; Neoplasms, Plasma Cell; Peripheral Nervous System Diseases; Multiple Myeloma; Lymphoma, Non-Hodgkin

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neuromuscular Diseases; Nervous System Diseases; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Results Point of Contact

• Title: Michael Wang, MD / Professor, Lymphoma/Myeloma
• Organization: University of Texas MD Anderson Cancer

CR_Study_Registration@mdanderson.org

713-792-2860

Study Officials

• Michael Wang, MD, BS

  UT MD Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

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: April 30, 2009
• First Posted: May 1, 2009
• Study Start: April 1, 2009
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: October 31, 2016
• Results First Posted: October 31, 2016

Record last verified: 2016-09

Locations

US (1)