Acupuncture for Chemotherapy-induced Peripheral Neuropathy

NCT ID: NCT01892852

Last Updated: 2013-07-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2014-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Acupuncture

Acupuncture treatment

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: 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.

Control

No other active treatment or sham acupuncture for this symptoms

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pusan National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ho-Jin Shin, PhD

Role: PRINCIPAL_INVESTIGATOR

Pusan National University Hospital

Locations

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

Busan, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Chang Woo Han, PhD

Role: CONTACT

yeast10@hanmail.net

+82-51-240-6835

Facility Contacts

Chang Woo Han, PhD

Role: primary

yeast10@hanmail.net

+82-51-240-6835

Other Identifiers

AcuCIPN

Identifier Type: -

Identifier Source: org_study_id