Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT00891618
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00891618
Study Brief:
Protocol Section:
NCT00891618