Acupuncture for Chemotherapy-induced Peripheral Neuropathy

Not Applicable

• Conditions: Peripheral Neuropathy; Toxicity Due to Chemotherapy; Lymphoma; Multiple Myeloma

• Registration Number: NCT01892852
• Lead Sponsor: Pusan National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-18
• Status Verified: 2013-07
• Study First Submitted QC: 2013-07-01
• Study First Posted: 2013-07-04
• Last Update Submitted: 2013-07-16
• Last Update Posted: 2013-07-17
• Primary Completion: 2014-04
• Study Completion: 2014-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

Department of Hematology-Oncology and Center for Integrative Medicine, Pusan National University Hospital; 🇰🇷 Busan, Korea, Republic of