Efficacy of Acupuncture in Prevention of Chemotherapy Induced Peripheral Neuropathy - a Pilot Study
NCT ID: NCT02744274
Last Updated: 2016-04-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
32 participants
INTERVENTIONAL
2016-01-31
2017-12-31
Brief Summary
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Detailed Description
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Chemotherapy-induced peripheral neuropathy (CIPN) is a disabling side effect of several commonly used antineoplastic agents. CIPN prevalence was 68.1% within the first month of the end of chemotherapy, 60% at 3 months, and 30.0% at 6 months or later. Oxaliplatin as a chemotherapeutic drug for colorectal cancer has neurotoxicity on peripheral nerve system. A definite portion of patients suffered neurologic symptoms including paresthesia, dysesthesia over limbs and perioral area accompanied with muscles cramps or spasm sometimes; however, had impact on quality of life, daily functions, quality of sleep and lead to distress and depression. There is no drug to prevent peripheral neuropathy. Clinical observations reveal that acupuncture could decrease peripheral neuropathy, improve quality of life, and promote motivation of complete chemotherapy course.
Material and methods:
A total of 32 volunteers of patients with colorectal cancer will be recruited from the Chinese medicine or Western medicine clinics in China Medical University Hospital. These patients will be randomized to receive verum acupuncture or sham acupuncture treatment two times biweekly, prior to beginning chemotherapy and the weeks that drugs administered, for 26 treatments in total.
Questionnaires, neurological examination and Von Frey Filament Test will be completed at baseline, 12 and 24 weeks after initiation of intervention, 12 and 24 weeks after completion of acupuncture completion.
Predict results:
Investigators expect that the efficacy of verum acupuncture is superior to sham acupuncture in prevent or postpone occurrence of chemotherapy induced peripheral neuropathy and able to improve numbness, paresthesia, quality of life. The effectiveness of acupuncture can be detected by questionnaires, Von Frey Filament Test and neurological testing.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Verum acupuncture
16 patients will be randomized to receive verum acupuncture two times biweekly, prior to beginning chemotherapy and the weeks that drugs administered, for 26 treatments in total.
Verum acupuncture
Patients will lay supine. The acupuncture physicians will disinfect the selected acupuncture points with alcohol and then needle them (30 gauze, 1.5-inch, Yuguang, Taiwan) with a plastic device is fixed needle body, so that the patient achieves a "de qi" sensation, which is often described as a pressure or achiness feeling. The acupuncture point will be bilateral Quchi, Waiguan, hegu, baxie, Zusanli, Yanglingquan, Sanyinjiao, Taichong, bafeng. Acupuncture needles will be left in place for approximately 30 minutes, and every 10 minutes twisting stainless steel needle to get a "de qi".
Sham acupuncture
16 patients will be randomized to receive sham acupuncture two times biweekly, prior to beginning chemotherapy and the weeks that drugs administered, for 26 treatments in total.
Verum acupuncture
Patients will lay supine. The acupuncture physicians will disinfect the selected acupuncture points with alcohol and then needle them (30 gauze, 1.5-inch, Yuguang, Taiwan) with a plastic device is fixed needle body, so that the patient achieves a "de qi" sensation, which is often described as a pressure or achiness feeling. The acupuncture point will be bilateral Quchi, Waiguan, hegu, baxie, Zusanli, Yanglingquan, Sanyinjiao, Taichong, bafeng. Acupuncture needles will be left in place for approximately 30 minutes, and every 10 minutes twisting stainless steel needle to get a "de qi".
Interventions
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Verum acupuncture
Patients will lay supine. The acupuncture physicians will disinfect the selected acupuncture points with alcohol and then needle them (30 gauze, 1.5-inch, Yuguang, Taiwan) with a plastic device is fixed needle body, so that the patient achieves a "de qi" sensation, which is often described as a pressure or achiness feeling. The acupuncture point will be bilateral Quchi, Waiguan, hegu, baxie, Zusanli, Yanglingquan, Sanyinjiao, Taichong, bafeng. Acupuncture needles will be left in place for approximately 30 minutes, and every 10 minutes twisting stainless steel needle to get a "de qi".
Eligibility Criteria
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Inclusion Criteria
2. Patients are going to receive Oxaliplatin based chemotherapy.
3. Patients are willing to cooperate with physicians and completely receive chemotherapy.
4. Patients are willing to receive acupuncture treatments and follow-up assessments.
5. Adult volunteers with the ages of 20-70 years old.
6. ECOG Performance Status of 0, 1, or 2
Exclusion Criteria
2. Having chemotherapy with neuropathic agents including taxane, platinum, vinca alkaloid, bortezimab, or thalidomide in the past six months.
3. Local infection at or near the acupuncture site is not suitable for acupuncture after physician examination.
4. Concurrent use of other alternative medicines such as herbal agents, high dose vitamins and minerals.
5. Known coagulopathy or taking anticoagulants.
6. Platelets \< 50000/ul.
7. WBCs \< 3000/ul.
8. Active CNS disease
9. Cardiac pacemaker.
10. Psychological or behavior disorder such as Schizophrenia.
11. Currently pregnant or breastfeeding women.
12. History of diabetic neuropathy or neuropathy related to HIV.
13. Previous acupuncture treatment for any indication within 30 days of enrollment.
14. Current medications that could affect symptoms related to CIPN.
15. Grade III lymphedema or more severe situation
20 Years
70 Years
ALL
No
Sponsors
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Research Center For Chinese Medicine and Acupuncture
UNKNOWN
Tzu-Liang Chen
OTHER
Responsible Party
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Tzu-Liang Chen
Deputy Superintendent of the Surgery department
Locations
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China Medical University Hospital
Taichung, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CMUH104-REC1-076
Identifier Type: -
Identifier Source: org_study_id
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