Acupuncture for Chemotherapy-induced Peripheral Neuropathy

Multiple Myeloma Clinical Trial

Official title:

Acupuncture Therapy for Chemotherapy-induced Peripheral Neuropathy in Lymphoma or Multiple Myeloma Patients: a Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01892852
• Other study ID #: AcuCIPN
• Status: Recruiting
• Phase: N/A
• First received: June 18, 2013
• Last updated: July 16, 2013
• Start date: June 2013
• Est. completion date: April 2014

Study information

• Verified date: July 2013
• Source: Pusan National University Hospital
• Contact: Chang Woo Han, PhD
• Phone: +82-51-240-6835
• Email: yeast10[@]hanmail.net
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Multiple Myeloma
• Neoplasms, Plasma Cell
• Peripheral Nervous System Diseases
• Peripheral Neuropathy
• Toxicity Due to Chemotherapy

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Department of Hematology-Oncology and Center for Integrative Medicine, Pusan National University Hospital	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change of VAS (Visual Analogue Scale) from baseline		At baseline, 1, 2, 3, and 7 wks from baseline	No
Secondary	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	No
Secondary	Adverse events		From study enrollment to the last follow-up (up to 7 wks)	Yes