Status:
UNKNOWN
Acupuncture for Chemotherapy-induced Peripheral Neuropathy
Lead Sponsor:
Pusan National University Hospital
Conditions:
Peripheral Neuropathy
Toxicity Due to Chemotherapy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate whether acupuncture can be effective for chemotherapy-induced peripheral neuropathy in lymphoma or multiple myeloma patients.
Eligibility Criteria
Inclusion
- At least 18 years of age and have diagnosis of a lymphoma or multiple myeloma.
- Patients must have chemotherapy-induced peripheral neuropathy greater or equal to 2 according to CTCAE (Common Terminology Criteria for Adverse Events) v 3.0 scale (Appendix A) in spite of previous conventional medications, e.g. Neurontin, Cymbalta and/or Lyrica. Patients receiving any of conventional medication for this symptoms must remain on the same medications throughout the study period.
- Patients, or the legal guardians of patients, must have the ability to understand Korean, and be ble to provide informed consent.
- ECOG (Eastern Cooperative Oncology Group) 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.
Exclusion
- Other diseases that, in the opinion of the investigators, can cause peripheral neuropathy, such as alcoholism, diabetes mellitus, and HIV.
- Current active treatment for lymphoma or multiple myeloma
- Ongoing local infection at or near the acupuncture point adopted in this trial.
- Severe immunocompromised patients, leukopenia ( \< 4,000/㎣) or neutropenia ( \< 1,500/㎣)
- Known coagulopathy, thrombocytopenia (\< 50,000/㎣), and taking heparin (including low molecular weight heparin) or Coumadin at any dose.
- Serious emotional or mental problems that precludes study entry.
- Mental and physical disability that precludes accurate acupuncture.
- Serious systemic diseases such as active infection, severe heart disease, uncontrolled hypertension and diabetes mellitus.
- Cardiac pacemaker.
- Pregnant or breastfeeding
- Acupuncture therapy within the previous 30 days
- Concurrent other complementary and alternative therapy such as herbal agents, high dose vitamins, and etc.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2014
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01892852
Start Date
June 1 2013
End Date
April 1 2014
Last Update
July 17 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Hematology-Oncology and Center for Integrative Medicine, Pusan National University Hospital
Busan, South Korea, 602-739