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.

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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer
• Intervention / Treatment: Other: Verum acupuncture

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: Interventional
• Enrollment (Anticipated): 32
• Phase: Phase 3

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 404
    • Recruiting
    • China Medical University Hospital
    • Contact: Tzu-Liang Chen, M.D., MS.; Phone Number: 1639 +886-4-22052121; Email: d1757@mail.cmuh.org.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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".

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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.

Collaborators and Investigators

• Sponsor: Tzu-Liang Chen
• Collaborators: Research Center For Chinese Medicine and Acupuncture

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: April 13, 2016
• First Submitted That Met QC Criteria: April 15, 2016
• First Posted (Estimate): April 20, 2016

Study Record Updates

• Last Update Posted (Estimate): April 21, 2016
• Last Update Submitted That Met QC Criteria: April 19, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: chemotherapy; peripheral neuropathy; acupuncture; randomized clinical trial; numbness
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases
• Other Study ID Numbers: CMUH104-REC1-076

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED