Acupuncture for Chemotherapy-induced Peripheral Neuropathy

NCT01892852 | Unknown

• 1 other identifier: AcuCIPN
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Neuropathy; Toxicity Due to Chemotherapy; Lymphoma; Multiple Myeloma

Keywords

Acupuncture; Traditional Korean Medicine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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)

Study Arms (2)

Acupuncture

EXPERIMENTAL

Acupuncture treatment

Procedure: Acupuncture

Control

NO INTERVENTION

No other active treatment or sham acupuncture for this symptoms

Interventions

Acupuncture PROCEDURE

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.

Acupuncture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pusan National University Hospital: lead

Study Sites (1)

Department of Hematology-Oncology and Center for Integrative Medicine, Pusan National University Hospital

Busan, 602-739, South Korea

RECRUITING

MeSH Terms

Conditions

Peripheral Nervous System Diseases; Lymphoma; Multiple Myeloma

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Ho-Jin Shin, PhD

  Pusan National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chang Woo Han, PhD

CONTACT

+82-51-240-6835; yeast10@hanmail.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2013
• First Posted: July 4, 2013
• Study Start: June 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: July 17, 2013

Record last verified: 2013-07

Locations

KR (1)