Acupuncture for Chemotherapy-induced Peripheral Neuropathy

Chemotherapy Induced Peripheral Neuropathy Clinical Trial

Official title:

The Efficacy and Safety of Acupuncture for Alleviating Chemotherapy-induced Peripheral Neuropathy in Colorectal Cancer Patients: a Pilot Single-blinded, Randomized Sham-controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03582423
• Other study ID #: HKBU-YCH
• Status: Completed
• Phase: N/A
• Start date: October 22, 2018
• Est. completion date: September 30, 2020

Study information

• Verified date: October 2020
• Source: Hong Kong Baptist University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, a 24-week, single blinded, randomized controlled clinical trial will be conducted to examine the efficacy and safety of acupuncture for Chemotherapy Induced Peripheral Neuropathy (CIPN) in colorectal cancer patients in Hong Kong.

Description:

This is a pilot single-blind, randomized, sham-controlled trial. 84 colorectal cancer patients will be randomly assigned to acupuncture group or control group. The duration of the treatment will be 12 weeks with 1 session per week and the follow-up period will be 12 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 30, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• aged =18 years old

• newly diagnosed with stage ?to ?colorectal cancer

• who plan to receive 8 cycles of adjuvant oxaliplatin-based chemotherapy

• who have not received any acupuncture

• life expectancy of = six months.

Exclusion Criteria:

• uncooperative subjects

• not be able to comprehend and communicate

• non-Chinese reading people

• having peripheral neuropathy caused by other diseases, for example, diabetes, stroke

• heart disease, for example, arrhythmia, heart failure, myocardial infarction or patients with pacemakers

• having a bleeding tendency

• be pregnant or lactating women

• having impaired hepatic or renal function

• using any pharmaceutical agents (for example, gabapentin, pregabalin), nutraceutical agents (for example, vitamin B6, vitamin E) and herbal medication for CIPN treatment.

Related Conditions & MeSH terms

• Chemotherapy Induced Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

Other:
• electro-acupuncture
Eight acupoints are chosen: he gu (LI4), nei guan (PC6), qu chi (LI12), ba xie (EX-UE9), zu san li (ST36), san yin jiao (SP6), tai chung (LV3) and ba feng (EX-LE10). The use of ba xie (EX-UE9) and ba feng (EX-LE10) will be optional if skin lesions of hands and feet occurs due to Capecitabine (Xeloda).Disposable acupuncture needles will be inserted at a depth of 10-25mm into the points. We will deliver electrical stimulation with continuous waves at 2 Hz, at an intensity of each patient's minimum sensation of stimulation through the electrical acupuncture stimulation instrument to the points. The needles will be retained in position for 25 minutes.

Locations

Country	Name	City	State
Hong Kong	Linda Zhong	Kowloon Tong	Kowloon

Sponsors (2)

Lead Sponsor	Collaborator
Hong Kong Baptist University	Princess Margaret Hospital, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in scores of Functional Assessment of Cancer Therapy/Gynecology Oncology Group/Neurotoxicity (FACT/GOC-Ntx) questionnaire	FACT/GOC-Ntx includes 11 questions covering sensory neuropathy, motor neuropathy, hearing neuropathy, and dysfunction associated with neuropathy. It results in a cumulative score ranging from 0 to 44, with the higher scores reflecting worse neuropathy symptoms. It will be assessed every week during 12-week treatment and the post-trial access will be performed at 15th, 18th, 21st and 24th week.	0,1,2,3,4,5,6,7,8,9,10,11,12,15,18,21,24 weeks
Secondary	Changes in scores of numerical rating scale (NRS) of numbness/pain score in hands and feet	patients will be asked to rate their average neuropathy symptoms within one week, on an 0 to 10 scale (0 = no symptoms; 10 = worst possible symptoms), those <4 of 10 NRS will be considered as mild CIPN while =4 of 10 NRS will be considered as moderate to severe CIPN. It will be assessed every week during 12-week treatment and the post-trial access will be performed at 15th, 18th, 21st and 24th week.	0,1,2,3,4,5,6,7,8,9,10,11,12,15,18,21,24 weeks
Secondary	Changes in scores of European Organization for Research and Treatment of Cancer (EORCTC) Quality of Life Questionnaire (QLQ-C30)	It is a 30-items questionnaire assessing five functional scales (physical, role, cognitive, emotional and social), three symptoms scales (fatigue, pain, nausea and vomiting), and other symptoms and problem in cancer patients (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulties).It will be assessed every 3 weeks during 12-week treatment and the post-trial access will be performed at 15th, 18th, 21st and 24th week.	0,3,6,9,12,15,18,21,24 weeks
Secondary	Changes in scores of Body Constitution of Chinese Medicine	Constitution of Chinese Medicine Questionnaire has 60 items measuring the 9 body constitution types: gentleness, Qi-deficiency, Yang-deficiency, Yin-deficiency, phlegm-wetness, wetness- heat, blood-stasis, Qi-depression, and special diathesis. It will be assessed at the end of treatment (12th week) and at the end of follow-up (24th week).	0,12,24 weeks
Secondary	Changes in response of vibration sense test	It is assessed by using the graduated Rydel-Seiffer tuning fork. It will be assessed every week during 12-week treatment and the post-trial access will be performed at 15th, 18th, 21st and 24th week.	0,1,2,3,4,5,6,7,8,9,10,11,12,15,18,21,24 weeks
Secondary	Changes in response of light touch test	It is assessed with standard 10g monofilaments, contained within the Neuropen. It will be assessed every week during 12-week treatment and the post-trial access will be performed at 15th, 18th, 21st and 24th week.	0,1,2,3,4,5,6,7,8,9,10,11,12,15,18,21,24 weeks
Secondary	Adverse events after treatment and follow up	Adverse events after treatment will be recorded and compared among the two groups. It will be assessed every week during 12-week treatment and the post-trial access will be performed at 15th, 18th, 21st and 24th week.	0,1,2,3,4,5,6,7,8,9,10,11,12,15,18,21,24 weeks