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Efficacy of Acupuncture in Prevention of Chemotherapy Induced Peripheral Neuropathy - a Pilot Study

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ClinicalTrials.gov Identifier: NCT02744274
Recruitment Status : Unknown
Verified April 2016 by Tzu-Liang Chen, China Medical University Hospital.
Recruitment status was:  Recruiting
First Posted : April 20, 2016
Last Update Posted : April 21, 2016
Sponsor:
Collaborator:
Research Center For Chinese Medicine and Acupuncture
Information provided by (Responsible Party):
Tzu-Liang Chen, China Medical University Hospital

Brief Summary:
The aim of this pilot study is to investigate the efficacy of acupuncture in prevention of chemotherapy induced peripheral neuropathy. The study adapted a single center, randomized, assessor- and participant-blinded, controlled, and parallel-design approach to investigate whether acupuncture can prevent or postpone the occurrence of peripheral neuropathy and improve quality of life.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Other: Verum acupuncture Phase 3

Detailed Description:

Background and purpose:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized, Assessor- and Participant-blinded, Controlled, and Parallel-design Approach to Investigate Whether Acupuncture Can Prevent or Postpone the Occurrence of Peripheral Neuropathy and Improve Quality of Life.
Study Start Date : January 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Other: 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".

Placebo Comparator: 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.
Other: 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".




Primary Outcome Measures :
  1. Change from Baseline in NCV at 48weeks. [ Time Frame: Baseline, 12 and 24 weeks after initiation of intervention, 12 and 24 weeks after completion of acupuncture completion. ]
  2. Change from Baseline in Von frey filament test at 48weeks. [ Time Frame: Baseline, 12 and 24 weeks after initiation of intervention, 12 and 24 weeks after completion of acupuncture completion. ]

Secondary Outcome Measures :
  1. Change from Baseline in questionnaire - FACT/GOG-Ntx Subscale at 48weeks. [ Time Frame: Baseline, 12 and 24 weeks after initiation of intervention, 12 and 24 weeks after completion of acupuncture completion. ]
  2. Change from Baseline in questionnaire - FACT-G at 48weeks. [ Time Frame: Baseline, 12 and 24 weeks after initiation of intervention, 12 and 24 weeks after completion of acupuncture completion. ]
  3. Change from Baseline in questionnaire - Brief Pain Inventory Short Form at 48weeks. [ Time Frame: Baseline, 12 and 24 weeks after initiation of intervention, 12 and 24 weeks after completion of acupuncture completion. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients were diagnosed as stage 3 colorectal cancer.
  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:

  1. Current active treatments with chemotherapy, radiotherapy or tumor resection surgery in the past one month.
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02744274


Contacts
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Contact: Tzu-Liang Chen, M.D., MS. +886-4-22052121 ext 1639 d1757@mail.cmuh.org.tw
Contact: Ming-Cheng Huang, M.D +886-4-22052121 ext 1670 mchuang1128@gmail.com

Locations
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Taiwan
China Medical University Hospital Recruiting
Taichung, Taiwan, 404
Contact: Tzu-Liang Chen, M.D., MS.    +886-4-22052121 ext 1639    d1757@mail.cmuh.org.tw   
Sponsors and Collaborators
Tzu-Liang Chen
Research Center For Chinese Medicine and Acupuncture

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Responsible Party: Tzu-Liang Chen, Deputy Superintendent of the Surgery department, China Medical University Hospital
ClinicalTrials.gov Identifier: NCT02744274     History of Changes
Other Study ID Numbers: CMUH104-REC1-076
First Posted: April 20, 2016    Key Record Dates
Last Update Posted: April 21, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Tzu-Liang Chen, China Medical University Hospital:
acupuncture
chemotherapy
peripheral neuropathy
randomized clinical trial
numbness

Additional relevant MeSH terms:
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Colorectal Neoplasms
Peripheral Nervous System Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neuromuscular Diseases
Nervous System Diseases