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

• Register: ClinicalTrials.gov
• Last refreshed on: 2 May 2016
• Main ID: NCT02744274
• Date of registration: 13/04/2016
• Prospective Registration: No
• Primary sponsor: Tzu-Liang Chen
• Public title: Efficacy of Acupuncture in Prevention of Chemotherapy Induced Peripheral Neuropathy - a Pilot Study
• Scientific 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.
• Date of first enrolment: January 2016
• Target sample size: 32
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02744274
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention
• Phase: Phase 3

Countries of recruitment

Taiwan

Contacts

• Name: Tzu-Liang Chen, M.D., MS.

• Name: Tzu-Liang Chen, M.D., MS.

Key inclusion & exclusion 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



Age minimum: 20 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Colorectal Cancer

Intervention(s)

Other: Verum acupuncture

Primary Outcome(s)

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.]

Secondary Outcome(s)

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.]

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.]

Secondary ID(s)

CMUH104-REC1-076

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Research Center For Chinese Medicine and Acupuncture