NCT01892852UnknownNot Applicable
Acupuncture Therapy for Chemotherapy-induced Peripheral Neuropathy in Lymphoma or Multiple Myeloma Patients: a Pilot Study
Pusan National University Hospital1 site in 1 country36 target enrollmentStarted: June 1, 2013Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Change of NCIC-CTC (National Cancer Institute of Canada - Common Toxicity Criteria) 4.0 scale from baseline
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Arms & Interventions
Acupuncture
Experimental
Acupuncture treatment
Intervention: Acupuncture (Procedure)
Control
No Intervention
No other active treatment or sham acupuncture for this symptoms
Outcomes
Primary Outcomes
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 Outcomes
- 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))
Investigators
Study Sites (1)
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