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The Use of Acupuncture to Reduce Chemotherapy Induced Peripheral Neuropathy in Gynaecological Cancer Patients
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. 1. Electroacupuncture group - patients will receive 6 weeks of electroacupuncture, 2 sessions per week, by a qualified Traditional Chinese Medicine practitioner from the School of Chinese Medicine. 2. Sham acupuncture group - patients will receive 6 weeks of sham acupuncture similar to the above. 3. Waiting-list (usual care) control group - patients will not receive any treatment. Main outcomes: Acupuncture effects will be assessed at baseline and 3, 6,12 weeks post intervention by: 1. Patient reported outcome measures: FACT/GOG-Ntx questionnaire for assessing CIPN symptoms and EORTC-QLQ-C30 and CIPN20 questionnaires for assessing quality of life symptom 2. Clinician reported outcome measures: NCI-CTCAE grading for CIPN by clinicians and Semmes-Weinstein monofilament test as an objective measurement of CIPN. 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-sampl
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