Clinical trial NCT01892852: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Neuropathy
Toxicity Due to Chemotherapy
Lymphoma
Multiple Myeloma
Keywords: Acupuncture
Traditional Korean Medicine
Lead sponsor: Pusan National University Hospital
Sponsor class: OTHER
First posted: 2013-07-04
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change of NCIC-CTC (National Cancer Institute of Canada - Common Toxicity Criteria) 4.0 scale from baseline
timeFrame: At baseline, 1, 2, 3, and 7 wks from baseline
Secondary outcomes:
measure: Change of VAS (Visual Analogue Scale) from baseline
timeFrame: At baseline, 1, 2, 3, and 7 wks from baseline
measure: Change of FACT/GOG-Ntx (Functional Assessment of Cancer Therapy/Gynecologic Oncology Group Neurotoxicity) from baseline
timeFrame: At baseline, 1, 2, 3, and 7 wks from baseline
measure: Adverse events
timeFrame: From study enrollment to the last follow-up (up to 7 wks)
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Department of Hematology-Oncology and Center for Integrative Medicine, Pusan National University Hospital
Study officials:
affiliation: Pusan National University Hospital
name: Ho-Jin Shin, PhD
role: PRINCIPAL_INVESTIGATOR
References: