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Trial Title:
Electro-acupuncture for the Prevention and Treatment of Oxaliplatin-induced Neurotoxicity in Colorectal Cancer Patients
NCT ID:
NCT05798884
Condition:
Colorectal Cancer
Oxaliplatin
Electro-acupuncture
Neurotoxicity
Conditions: Official terms:
Colorectal Neoplasms
Neurotoxicity Syndromes
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Masking description:
All patients and the investigators including the research assessors, the statistician,
and the researchers interacting with the patients except the one who conducts the
acupuncture therapy will be blinded.
Intervention:
Intervention type:
Device
Intervention name:
Acupuncture
Description:
Disposable acupuncture needles (0.25 mm in diameter and 25 mm in length) are straightly
into body acupuncture points (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 occur due to Capecitabine (Xeloda). Electrical stimulation will be
delivered with continuous waves at 2 Hz, at an intensity of each patient's minimum
sensation of stimulation through the electrical acupuncture stimulation instrument. The
needles will be retained in position for 25 minutes.
Arm group label:
Electro-acupuncture group
Intervention type:
Device
Intervention name:
Sham-acupuncture
Description:
Streitberger's non-invasive acupuncture needles (Gauge 8 x 1.2"/ 0.30 x 30mm) will be
applied to serve as a sham control at the same acupoints with the same stimulation
modality and then connecting the needle to the incorrect output socket of the electrical
acupuncture stimulation instrument. The sham points are "pseudo stimulation".
Arm group label:
sham-acupuncture group
Summary:
In this study, a 24-week randomized, sham-controlled, single-blind, multicenter clinical
trial will be conducted to explore the effect of electroacupuncture for prevention and
treatment of both acute and chronic neurotoxicity through both clinical and biological
indicators.
Detailed description:
This is a prospective, randomized, sham-controlled, double-blinded and multiple center
trial on electro-acupuncture for preventing and treating symptoms of chemotherapy-induced
neurotoxicity in patients with colorectal cancer. A total of 150 candidates will be
recruited in this study four weeks before chemotherapy for best preventive effect. They
will be assigned randomly into either the electro-acupuncture or the sham-control group
with 1:1 ratio. Both groups will receive a total of 24 sessions of interventions (4 weeks
before chemotherapy and 8 weeks during chemotherapy, with 2 session per week), and will
be followed up regularly for up to 12 weeks after completion of the acupuncture.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- are aged ≥18 years old;
- are newly diagnosed with stage II to IV colorectal cancer;
- going to receive adjuvant oxaliplatin-based chemotherapy within 4 weeks;
- had not received any acupuncture in the previous 3 months and had a life expectancy
≥ of six months.
Exclusion Criteria:
- are not able to comprehend and communicate;
- are not able to read Chinese;
- have prior peripheral neuropathy caused by other diseases including diabetes,
stroke, cardiovascular diseases such as arrhythmia, heart failure, myocardial
infarction, and patients with cardiac pacemakers;
- have a bleeding tendency;
- are pregnant or breastfeeding;
- have impaired hepatic or renal function;
- using any pharmaceutical agents e.g., vitamin B6 and vitamin E, or herbal
medication. All the above medication prescribed by physicians or Chinese medicine
practitioners during the study will be recorded.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Linda Zhong
Address:
City:
Kowloon Tong
Country:
Hong Kong
Start date:
May 2023
Completion date:
April 2025
Lead sponsor:
Agency:
Hong Kong Baptist University
Agency class:
Other
Collaborator:
Agency:
Princess Margaret Hospital, Hong Kong
Agency class:
Other
Collaborator:
Agency:
Queen Mary Hospital, Hong Kong
Agency class:
Other
Source:
Hong Kong Baptist University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05798884
https://www3.ha.org.hk/cancereg/
