Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
27 participants
INTERVENTIONAL
2009-04-30
2013-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Acupuncture involves the insertion of small, solid, sterile needles into specific points on the skin. In this study, the needles are placed in areas that are intended to help relieve numbness and tingling of the feet and hands. Weak electrical stimulation is also applied to the needles to try to improve the treatment effects of the acupuncture.
Acupuncture Sessions:
Your first acupuncture session will be on the same day as the tests described above, if possible. (If not, it will be scheduled for another day that will be no more than about 10 days after the screening visit.)
You will have an acupuncture session 3 times per week for 4 weeks (Weeks 1-4). You will then have 1 week off (Week 5). After that, you will have an acupuncture session twice per week for 4 more weeks (Weeks 6-10). This is a total of 20 sessions. In addition to the 20 planned sessions, you may also choose to receive an optional 21st acupuncture session at the end-of-study visit that is scheduled for Week 13.
For each session, you will be placed in a comfortable position and the study doctor/acupuncturist will find points on your body where the needles will be placed. All study participants will have the needles placed at the same points on the body (the hands, feet, legs, abdomen, and scalp).
Very thin, solid, sterile, stainless steel needles will be used. All of the needles are specially made for acupuncture. The depth of the needle in the skin and the number of needles used is based on standard acupuncture procedures. The needles will remain in place for about 20-30 minutes.
Electrical stimulation will be added to some of the needles on the feet and hands. This involves placing wires on the needles, which are connected to a machine that delivers a weak electrical current through the wires. The strength of the electrical current will be changed slowly until it is at a comfortable level for you.
Study Procedures:
At each session, before you receive the acupuncture, the following procedures will be performed:
* Your vital signs will be measured.
* You will be asked about any drugs you may be taking and any side effects you may be experiencing.
* The color and coating of your tongue and the quality of your pulse will be recorded.
Once a week, you will also be asked to complete the same 3 questionnaires as you did at the beginning of the study.
Most study visits will last about 1 hour. On the weeks that you complete the questionnaires, it may add about 15-20 minutes.
During the study, you may still receive your regular pain treatments. If you are receiving Neurontin (gabapentin), Cymbalta (duloxetine), and/or Lyrica (pregabalin), you must stay on the same drug(s) until you go off this study. Minor changes in the doses of your pain treatments are allowed, but if there is a large change, you will be taken off study early.
Length of Study Participation:
You may receive up to 21 acupuncture sessions over 13 weeks. If intolerable side effects or symptoms occur, you will be taken off study early.
End-of-Study Visit:
At Week 13, or if you go off study early for any reason, you will have an end-of-study visit. If the doctor thinks it is necessary, the following procedures will be performed:
* Your medical history will be recorded.
* Your vital signs will be measured.
* You will be asked about any drugs you may be taking and any side effects you may have experienced.
* You will complete the same 3 questionnaires as before.
* The 4 nerve tests will be repeated in order to learn if there have been any changes in your nerve function.
* Your tongue and pulse will be evaluated.
After the end-of-study visit, your participation in this study will be over.
This is an investigational study. The acupuncture needles used in this study are commercially available and FDA approved. It is considered experimental, however, to use acupuncture to treat numbness and/or tingling in the feet and/or hands that is related to chemotherapy.
Up to 30 patients will take part in this study. All will be enrolled at The University of Texas (UT) MD Anderson Cancer Center.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Millennium Pharmaceuticals, Inc.
INDUSTRY
M.D. Anderson Cancer Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michael Wang, MD, BS
Role: PRINCIPAL_INVESTIGATOR
UT MD Anderson Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UT MD Anderson Cancer Center
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Related Links
Access external resources that provide additional context or updates about the study.
UT MD Anderson Cancer Center website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2006-0679
Identifier Type: -
Identifier Source: org_study_id