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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

Tracking Information
First Submitted Date  ICMJE April 13, 2016
First Posted Date  ICMJE April 20, 2016
Last Update Posted Date April 21, 2016
Study Start Date  ICMJE January 2016
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2016)
  • 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. ]
  • 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. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02744274 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2016)
  • 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. ]
  • 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. ]
  • 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. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Acupuncture in Prevention of Chemotherapy Induced Peripheral Neuropathy - a Pilot Study
Official Title  ICMJE 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.
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE 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".
Study Arms  ICMJE
  • 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.
    Intervention: Other: Verum acupuncture
  • 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.
    Intervention: Other: Verum acupuncture
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 15, 2016)
32
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02744274
Other Study ID Numbers  ICMJE CMUH104-REC1-076
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Tzu-Liang Chen, China Medical University Hospital
Study Sponsor  ICMJE Tzu-Liang Chen
Collaborators  ICMJE Research Center For Chinese Medicine and Acupuncture
Investigators  ICMJE Not Provided
PRS Account China Medical University Hospital
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP