The Use of Acupuncture to Reduce Chemotherapy Induced Peripheral Neuropathy (CIPN) in Gynaecological Cancer Patients - A Pilot Randomised Controlled Trial
The Use of Acupuncture to Reduce Chemotherapy Induced Peripheral Neuropathy (CIPN) in Gynaecological Cancer Patients - A Pilot Randomised Controlled Trial
Objectives:
To explore the feasibility and effectiveness of acupuncture on reducing Chemotherapy Induced Peripheral Neuropathy (CIPN) in gynaecological cancer patients who have received carboplatin and paclitaxel chemotherapy combination. Results of this pilot trial will provide preliminary information for a potential a larger scale multicentre study.
Hypothesis:
Acupuncture can significantly reduce CIPN in gynaecological cancer patients treated with chemotherapy
Design and subjects:
This is a pilot, prospective randomised controlled trial. This is an exploratory trial to evaluate the feasibility and effectiveness of acupuncture in reducing CIPN in gynaecological cancer patients. Eligible patients will be 1:1:1 randomised to three groups: electroacupuncture group, sham acupuncture group and waiting-list (usual care) control group. For electroacupuncture and sham acupuncture groups, the assessors and the patients will be blinded to the treatment given.
Main outcomes:
Acupuncture effects will be assessed at baseline and 3, 6,12 weeks post intervention by:
Data analysis:
Intention to treat analysis will be carried out. Baseline demographics will be compared between the 3 groups. Change from baseline total score will be calculated and analysed using 2-sample t-test. 95% CI will be reported for treatment differences. Score for different subcategories will be analysed in a similar manner. Data collected at week 6 will be used for outcome analysis. P<0.05 will be considered as statistically significant. Acupuncture efficacy, effectiveness and placebo effect will be indicated by comparison of acupuncture vs. sham acupuncture, acupuncture vs. waiting-list, and sham acupuncture vs. waiting-list, respectively.
Expected results: Patients in the acupuncture arm will have reduced numbness and peripheral neuropathy and improved quality of life without any adverse event.
Subjects will be recruited by research assistant at the gynaecological oncology clinics at Queen Mary Hospital. All potential subjects will be required to fill in a screening questionnaire to assess the degree of neuropathy. Screening blood test (Complete blood picture) will be taken within 1 month of starting acupuncture. Eligible subjects will be enrolled into the study according to the inclusion and exclusion criteria. Any type of acupuncture or message in daily Traditional Chinese Medicine clinic will be prohibited during the trial once the subject is enrolled.
Subjects will be allocated to the 3 groups through computer generated randomization: acupuncture, sham acupuncture or the waiting-list (usual care) control group on a 1:1:1 ratio. Allocations will be kept within sealed opaque envelopes. Once a patient has been enrolled, an envelope is opened and the patient is then offered the allocated treatment regimen. Both the subjects (acupuncture and sham acupuncture group) and the gynaecological clinical research team responsible for the clinical care and neuropathy assessments will be blinded to the results.
Patients who are randomised to sham acupuncture or waiting-list control group will be offered the option of receiving 12 acupuncture treatments when they finish all study procedures.
Inclusion Criteria:
Exclusion Criteria:
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