Acupuncture for Chemo-induced Peripheral Neuropathy in Multiple Myeloma and Lymphoma Patients
18 Years
N/A
Both
Lymphoma, Myeloma, Peripheral Neuropathy
Trial Information
Acupuncture for Chemo-induced Peripheral Neuropathy in Multiple Myeloma and Lymphoma Patients
Acupuncture:
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 M. D. Anderson.
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Neuropathy Severity (FACT-GOG-Ntx Total Score Assessment)
Outcome Time Frame:
At baseline, once per week during two treatment phases of study, and one month (week 13) after last acupuncture treatment.
Safety Issue:
Yes
Principal Investigator
Michael Wang, MD, BS
Investigator Role:
Principal Investigator
Investigator Affiliation:
UT MD Anderson Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
2006-0679
NCT ID:
NCT00891618
Start Date:
April 2009
Completion Date:
Related Keywords:
- Lymphoma
- Myeloma
- Peripheral Neuropathy
- Lymphoma
- Myeloma
- Multiple Myeloma
- MM
- Non-Hodgkin's Lymphoma
- NHL
- Acupuncture
- Treatment-induced Peripheral Neuropathy
- Thalidomide
- Bortezomib
- Neuropathy
- Peripheral Neuropathy
- Lymphoma
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Peripheral Nervous System Diseases
- Demyelinating Diseases
- Polyneuropathies
- Nerve Compression Syndromes
- Neurologic Manifestations
- Neurotoxicity Syndromes
Name | Location |
|---|---|
| UT MD Anderson Cancer Center | Houston, Texas 77030 |
