Chemotherapy Induced Peripheral Neuropathy
Conditions
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.
Interventions
OTHERelectro-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.
Sponsors
Princess Margaret Hospital, Hong Kong
Hong Kong Baptist University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Subjects of both groups will be randomly assigned to receive either electro-acupuncture or control (sham) treatment. For randomization, simple, complete non-sequential random numbers will be generated in advance by a computer program in a block of four, and kept by the principal investigator. After a patient's eligibility is confirmed, a randomization number which corresponds to the group allocation will be provided to the acupuncturist by the PI. This arrangement will ensure that the clinical assessor and participants are blinded to the allocation.
Intervention model description
single-blinded, randomized, sham-acupuncture controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in scores of Functional Assessment of Cancer Therapy/Gynecology Oncology Group/Neurotoxicity (FACT/GOC-Ntx) questionnaire | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| Changes in scores of Body Constitution of Chinese Medicine | 0,12,24 weeks | 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). |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
Countries
Hong Kong
Outcome results
None listed