Efficacy of Acupuncture in Prevention of Chemotherapy Induced Peripheral Neuropathy - a Pilot Study
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.
1 other identifier
interventional
32
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 colorectal-cancer
Started Jan 2016
Shorter than P25 for phase_3 colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 13, 2016
CompletedFirst Posted
Study publicly available on registry
April 20, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedApril 21, 2016
April 1, 2016
1.9 years
April 13, 2016
April 19, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change from Baseline in NCV at 48weeks.
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.
Baseline, 12 and 24 weeks after initiation of intervention, 12 and 24 weeks after completion of acupuncture completion.
Secondary Outcomes (3)
Change from Baseline in questionnaire - FACT/GOG-Ntx Subscale at 48weeks.
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.
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.
Baseline, 12 and 24 weeks after initiation of intervention, 12 and 24 weeks after completion of acupuncture completion.
Study Arms (2)
Verum acupuncture
EXPERIMENTAL16 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.
Sham acupuncture
PLACEBO COMPARATOR16 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.
Interventions
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
You may qualify if:
- Patients were diagnosed as stage 3 colorectal cancer.
- Patients are going to receive Oxaliplatin based chemotherapy.
- Patients are willing to cooperate with physicians and completely receive chemotherapy.
- Patients are willing to receive acupuncture treatments and follow-up assessments.
- Adult volunteers with the ages of 20-70 years old.
- ECOG Performance Status of 0, 1, or 2
You may not qualify if:
- Current active treatments with chemotherapy, radiotherapy or tumor resection surgery in the past one month.
- Having chemotherapy with neuropathic agents including taxane, platinum, vinca alkaloid, bortezimab, or thalidomide in the past six months.
- Local infection at or near the acupuncture site is not suitable for acupuncture after physician examination.
- Concurrent use of other alternative medicines such as herbal agents, high dose vitamins and minerals.
- Known coagulopathy or taking anticoagulants.
- Platelets \< 50000/ul.
- WBCs \< 3000/ul.
- Active CNS disease
- Cardiac pacemaker.
- Psychological or behavior disorder such as Schizophrenia.
- Currently pregnant or breastfeeding women.
- History of diabetic neuropathy or neuropathy related to HIV.
- Previous acupuncture treatment for any indication within 30 days of enrollment.
- Current medications that could affect symptoms related to CIPN.
- Grade III lymphedema or more severe situation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
China Medical University Hospital
Taichung, 404, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Deputy Superintendent of the Surgery department
Study Record Dates
First Submitted
April 13, 2016
First Posted
April 20, 2016
Study Start
January 1, 2016
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
April 21, 2016
Record last verified: 2016-04