MDACC Study Summary 2006-0679

Study Summary
No. 2006-0679:.......Lymphoma; Myeloma......Michael Wang......Lymphoma/Myeloma

Study Summary Title



Study Summary Number:	2006-0679

Study Title:	Acupuncture for chemo-induced peripheral neuropathy in multiple myeloma and lymphoma patients

Physician

New Patient Referral



Name:	Michael Wang	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Lymphoma/Myeloma	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-2860 Contact us about clinical trials

General Information



Disease Group:	Lymphoma Myeloma	Supported By:	Millennium Pharmaceuticals, Inc

Phase of Study:	Phase II	Return Visit:	Patients must come to MDACC 3 times per week for 4 weeks, skip one week, then 2 times per week for 4 weeks, then for the one-month follow-up at week 13.

Treatment Agents:	Acupuncture	Home Care:	n/a

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	n/a


Description/ Intervention:	Unavailable

Study Objectives / Outcomes

The purpose of this phase II non-randomized pilot study is to determine if treatment-induced peripheral neuropathy can be reversed using acupuncture. We will also evaluate the safety and feasibility of providing acupuncture to multiple myeloma and lymphoma patients at M. D. Anderson Cancer Center (MDACC) and evaluate if the cumulative dosage of thalidomide and/or bortezomib is related to the severity and frequency of peripheral neuropathy in this patient population.

1.1 Primary Objective: To assess the efficacy of acupuncture on the subjective evaluation of symptoms related to treatment-induced peripheral neuropathy among multiple myeloma and/or lymphoma patients at MDACC.

1.2 Secondary Objectives:

a. To assess the effects of acupuncture on nerve conduction / function among multiple myeloma and/or lymphoma patients at MDACC who are experiencing treatment-induced peripheral neuropathy.
b. To determine the feasibility of providing acupuncture to multiple myeloma and lymphoma patients at M.D. Anderson Cancer Center.
c. To determine if the cumulative dosage of thalidomide and/or bortezomib is related to the severity and frequency of peripheral neuropathy.

Study Status Information



Study Activation / Registration Date:	04/30/2009

IRB Review and Approval Date:	01/10/2008

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Open

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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.

Links

Registration Number: NCT00891618
Study Information on Clinical Trials Registry (clinicaltrials.gov)