Acupuncture for Chemotherapy-induced Peripheral Neuropathy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Acupuncture Acupuncture treatment |
Procedure: Acupuncture
Acupuncture treatment will be performed by licensed doctors in Traditional Korean Medicine using 0.20 mm (diameter) X 0.40 mm (length) sized disposable acupuncture 3 times per week for 3 weeks. Acupuncture points are GV20, GB20 (bilateral), LI11 (bilateral), LI10 (bilateral), EX-UE9 (bilateral), ST36 (bilateral), ST40 (bilateral), and EX-LE10 (bilateral). Each session lasts 20-30 minutes.
|
| No Intervention: Control No other active treatment or sham acupuncture for this symptoms |
Outcome Measures
Primary Outcome Measures
- Change of NCIC-CTC (National Cancer Institute of Canada - Common Toxicity Criteria) 4.0 scale from baseline [At baseline, 1, 2, 3, and 7 wks from baseline]
Secondary Outcome Measures
- Change of VAS (Visual Analogue Scale) from baseline [At baseline, 1, 2, 3, and 7 wks from baseline]
- Change of FACT/GOG-Ntx (Functional Assessment of Cancer Therapy/Gynecologic Oncology Group Neurotoxicity) from baseline [At baseline, 1, 2, 3, and 7 wks from baseline]
- Adverse events [From study enrollment to the last follow-up (up to 7 wks)]
Eligibility Criteria
Criteria
Inclusion Criteria:
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At least 18 years of age and have diagnosis of a lymphoma or multiple myeloma.
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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.
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Patients, or the legal guardians of patients, must have the ability to understand Korean, and be ble to provide informed consent.
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ECOG (Eastern Cooperative Oncology Group) Performance Status of 0, 1, or 2.
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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:
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Other diseases that, in the opinion of the investigators, can cause peripheral neuropathy, such as alcoholism, diabetes mellitus, and HIV.
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Current active treatment for lymphoma or multiple myeloma
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Ongoing local infection at or near the acupuncture point adopted in this trial.
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Severe immunocompromised patients, leukopenia ( < 4,000/㎣) or neutropenia ( < 1,500/㎣)
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Known coagulopathy, thrombocytopenia (< 50,000/㎣), and taking heparin (including low molecular weight heparin) or Coumadin at any dose.
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Serious emotional or mental problems that precludes study entry.
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Mental and physical disability that precludes accurate acupuncture.
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Serious systemic diseases such as active infection, severe heart disease, uncontrolled hypertension and diabetes mellitus.
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Cardiac pacemaker.
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Pregnant or breastfeeding
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Acupuncture therapy within the previous 30 days
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Concurrent other complementary and alternative therapy such as herbal agents, high dose vitamins, and etc.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Hematology-Oncology and Center for Integrative Medicine, Pusan National University Hospital | Busan | Korea, Republic of | 602-739 |
Sponsors and Collaborators
- Pusan National University Hospital
Investigators
- Principal Investigator: Ho-Jin Shin, PhD, Pusan National University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AcuCIPN