The Efficacy and Safety of Acupuncture for Alleviating Chemotherapy-induced Peripheral Neuropathy in Colorectal Cancer Patients: a Pilot Single-blinded, Randomized Sham-controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chemotherapy Induced Peripheral Neuropathy
- Sponsor
- Hong Kong Baptist University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Changes in scores of Functional Assessment of Cancer Therapy/Gynecology Oncology Group/Neurotoxicity (FACT/GOC-Ntx) questionnaire
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief 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.
Detailed 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.
Investigators
Zhong Lidan
Research Assistant Professor
Hong Kong Baptist University
Eligibility Criteria
Inclusion Criteria
- •aged ≥18 years old
- •newly diagnosed with stage Ⅱto Ⅲcolorectal 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.
Outcomes
Primary Outcomes
Changes in scores of Functional Assessment of Cancer Therapy/Gynecology Oncology Group/Neurotoxicity (FACT/GOC-Ntx) questionnaire
Time Frame: 0,1,2,3,4,5,6,7,8,9,10,11,12,15,18,21,24 weeks
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.
Secondary Outcomes
- Changes in scores of numerical rating scale (NRS) of numbness/pain score in hands and feet(0,1,2,3,4,5,6,7,8,9,10,11,12,15,18,21,24 weeks)
- Changes in scores of European Organization for Research and Treatment of Cancer (EORCTC) Quality of Life Questionnaire (QLQ-C30)(0,3,6,9,12,15,18,21,24 weeks)
- Changes in scores of Body Constitution of Chinese Medicine(0,12,24 weeks)
- Adverse events after treatment and follow up(0,1,2,3,4,5,6,7,8,9,10,11,12,15,18,21,24 weeks)
- Changes in response of vibration sense test(0,1,2,3,4,5,6,7,8,9,10,11,12,15,18,21,24 weeks)
- Changes in response of light touch test(0,1,2,3,4,5,6,7,8,9,10,11,12,15,18,21,24 weeks)