The Use of Acupuncture to Reduce Chemotherapy Induced Peripheral Neuropathy (CIPN) in Gynaecological Cancer Patients - A Pilot Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Chemotherapy Induced Peripheral Neuropathy associated quality of life measured by Functional Assessment of Cancer Therapy / Gynecologic Oncology Group - Neurotoxicity subscale (FACT/GOG-NTX) total score
研究概览
简要总结
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.
- 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.
- Sham acupuncture group - patients will receive 6 weeks of sham acupuncture similar to the above.
- 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:
- 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
- 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-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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Patients will be randomised into three groups. 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. There is no blinding for waiting-list control group.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18 or above
- •Diagnosis of uterine (endometrial) cancer, ovarian cancer and cervical cancer
- •Life expectancy of > 6 months
- •Completed at least 6 cycles of carboplatin or cisplatin chemotherapy together with paclitaxel at least 3 months before joining the study
- •Able to read and understand the questionnaires
- •PNQ score of C or above
排除标准
- •Bleeding tendency
- •Abnormal clotting profile
- •Platelet lower than 50
- •Received acupuncture in the past
- •Currently receiving chemotherapy treatment
- •Known neurological disorders or pre-existing neuropathy unrelated to chemotherapy
- •Routinely take aspirin or any anticoagulant drugs
- •Having active skin infection
- •With pacemaker
研究组 & 干预措施
Acupuncture
Patients randomised to this arm will receive intervention of electroacupuncture. They will receive 6 weeks of electroacupuncture, 2 sessions per week, 30 min per session.
干预措施: Acupuncture (Procedure)
Sham acupuncture
Patients randomised to this arm will receive sham comparator, sham acupuncture. They will receive 6 weeks of sham acupuncture, 2 sessions per week, 30 min per session.
干预措施: sham acupuncture (Device)
Waiting-list (usual care) control
Patients randomised to the waiting-list control group will receive standard of care managementf for CIPN.
结局指标
主要结局
Chemotherapy Induced Peripheral Neuropathy associated quality of life measured by Functional Assessment of Cancer Therapy / Gynecologic Oncology Group - Neurotoxicity subscale (FACT/GOG-NTX) total score
时间窗: From enrollment to 6 weeks after end of treatment including: baseline at enrollment, after 3 weeks of treatment/enrollment, after 6 weeks of treatment (end of treatment)/ enrollment, and 6 weeks after end of treatment /12 weeks after enrollment
This questionnaire provides a targeted assessment of peripheral neuropathy symptoms. It consists of a total of 38 items on physical, social, emotional and functioning well-being with 11 questions focusing on neurotoxicity. This instrument is validated and has been used in Phase 3 clinical trials. The higher the score, the better the quality of life.
次要结局
- The changes in quality of life assessed by European Organisation For Research And Treatment Of Cancer-Quality of Life-C30 (EORTC-QLQ-C30) questionnaires(From enrollment to 6 weeks after end of treatment including: baseline at enrollment, after 3 weeks of treatment/enrollment, after 6 weeks of treatment (end of treatment)/ enrollment, and 6 weeks after end of treatment /12 weeks after enrollment)
- The changes in quality of life assessed by European Organisation For Research And Treatment Of Cancer-Quality of Life-Chemotherapy Induced Peripheral Neuropathy 20 (EORTC-QLQ-CIPN20) questionnaires(From enrollment to 6 weeks after end of treatment including: baseline at enrollment, after 3 weeks of treatment/enrollment, after 6 weeks of treatment (end of treatment)/ enrollment, and 6 weeks after end of treatment /12 weeks after enrollment)
- assess the changes in light touch sensation by Semmes-Weinstein filaments test(From enrollment to 6 weeks after end of treatment including: baseline at enrollment, after 3 weeks of treatment/enrollment, after 6 weeks of treatment (end of treatment)/ enrollment, and 6 weeks after end of treatment /12 weeks after enrollment)
- assess the safety by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) grading(From enrollment to 6 weeks after end of treatment including: baseline at enrollment, after 3 weeks of treatment/enrollment, after 6 weeks of treatment (end of treatment)/ enrollment, and 6 weeks after end of treatment /12 weeks after enrollment)
- assess the chemotherapy induced peripheral pain in numeric rating scale(From enrollment to 6 weeks after end of treatment including: baseline at enrollment, after 3 weeks of treatment/enrollment, after 6 weeks of treatment (end of treatment)/ enrollment, and 6 weeks after end of treatment /12 weeks after enrollment)
- Explore the acupuncture expectancy by Acupuncture expectancy scale (for acupuncture and sham acupuncture group)(At baseline and week 3 (after receiving treatment for 3 weeks))
- Explore the acupuncture credibility by Acupuncture credibility questionnaire (for acupuncture and sham acupuncture group)(At week 3 (after receiving treatment for 3 weeks))
- Changes in inflammatory biomarkers(From enrollment to end of treatment including: baseline at enrollment, after 6 weeks of treatment (end of treatment)/ enrollment)
研究者
Karen Kar Loen CHAN
Department Chairperson and Clinical Professor
The University of Hong Kong