Acupuncture for Chemotherapy-induced Peripheral Neuropathy

P

Pusan National University

Status

Unknown

Conditions

Peripheral Neuropathy
Multiple Myeloma
Lymphoma
Toxicity Due to Chemotherapy

Treatments

Procedure: Acupuncture

Study type

Interventional

Funder types

Other

Identifiers

NCT01892852
AcuCIPN

Details and patient eligibility

About

The purpose of this study is to evaluate whether acupuncture can be effective for chemotherapy-induced peripheral neuropathy in lymphoma or multiple myeloma patients.

Enrollment

36 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

36 participants in 2 patient groups

Acupuncture
Experimental group
Description:
Acupuncture treatment
Treatment:
Procedure: Acupuncture
Control
No Intervention group
Description:
No other active treatment or sham acupuncture for this symptoms

Trial contacts and locations

1

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Central trial contact

Chang Woo Han, PhD

Data sourced from clinicaltrials.gov

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