Back to results

Acupuncture for Chemotherapy-induced Peripheral Neuropathy

Primary Purpose

Peripheral Neuropathy, Toxicity Due to Chemotherapy, Lymphoma

Status

Unknown status

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Acupuncture

About this trial

This is an interventional treatment trial for Peripheral Neuropathy focused on measuring Acupuncture, Traditional Korean Medicine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Acupuncture

Control

Arm Description

Acupuncture treatment

No other active treatment or sham acupuncture for this symptoms

Outcomes

Primary Outcome Measures

Change of NCIC-CTC (National Cancer Institute of Canada - Common Toxicity Criteria) 4.0 scale from baseline

Secondary Outcome Measures

Change of VAS (Visual Analogue Scale) from baseline

Change of FACT/GOG-Ntx (Functional Assessment of Cancer Therapy/Gynecologic Oncology Group Neurotoxicity) from baseline

Adverse events

Full Information

NCT ID

NCT01892852

First Posted

June 18, 2013

Last Updated

July 16, 2013

Sponsor

Pusan National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01892852

Brief Title

Acupuncture for Chemotherapy-induced Peripheral Neuropathy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2013

Overall Recruitment Status

Unknown status

Study Start Date

June 2013 (undefined)

Primary Completion Date

April 2014 (Anticipated)

Study Completion Date

April 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pusan National University Hospital

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Acupuncture, Traditional Korean Medicine

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Acupuncture

Arm Type

Experimental

Arm Description

Acupuncture treatment

Arm Title

Control

Arm Type

No Intervention

Arm Description

No other active treatment or sham acupuncture for this symptoms

Intervention Type

Procedure

Intervention Name(s)

Acupuncture

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change of NCIC-CTC (National Cancer Institute of Canada - Common Toxicity Criteria) 4.0 scale from baseline

Time Frame

At baseline, 1, 2, 3, and 7 wks from baseline

Secondary Outcome Measure Information:

Title

Change of VAS (Visual Analogue Scale) from baseline

Time Frame

At baseline, 1, 2, 3, and 7 wks from baseline

Title

Change of FACT/GOG-Ntx (Functional Assessment of Cancer Therapy/Gynecologic Oncology Group Neurotoxicity) from baseline

Time Frame

At baseline, 1, 2, 3, and 7 wks from baseline

Title

Adverse events

Time Frame

From study enrollment to the last follow-up (up to 7 wks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chang Woo Han, PhD

Phone

+82-51-240-6835

yeast10@hanmail.net

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ho-Jin Shin, PhD

Organizational Affiliation

Pusan National University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Busan

ZIP/Postal Code

602-739

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chang Woo Han, PhD

Phone

+82-51-240-6835

yeast10@hanmail.net

First Name & Middle Initial & Last Name & Degree

Ho-Jin Shin, MD, PhD

First Name & Middle Initial & Last Name & Degree

Chang Woo Han, PhD

First Name & Middle Initial & Last Name & Degree

Eui-Hyoung Hwang, PhD

12. IPD Sharing Statement

Learn more about this trial

Acupuncture for Chemotherapy-induced Peripheral Neuropathy

We'll reach out to this number within 24 hrs