The Use of Acupuncture to Reduce Chemotherapy Induced Peripheral Neuropathy in Gynaecological Cancer Patients

Официальное название

The Use of Acupuncture to Reduce Chemotherapy Induced Peripheral Neuropathy (CIPN) in Gynaecological Cancer Patients - A Pilot Randomised Controlled Trial

Обзор

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-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.

Подробное описание

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.

Вмешательства

• Процедура Acupuncture
  Patients will receive 6 weeks of electroacupuncture, 2 sessions per week, 30 min per session Stainless steel, single-use, sterile, and disposable needles will be used. We will use the bilateral acupoints LI4 (He-Gu), TE5 (Wai-Guan), LI11 (Qu-Chi), and LU5 (Chi-Ze) for upper limbs. For lower limb numbness, we will use the bilateral acupoints of LV3 (Tai-Chong), ST41 (Jie-Xi), SP6 (San-Yin-Jiao), and GB34 (Yang-Ling-Quan) for the numbness of back of feet, or the bilateral acupoints of KI1 (Yong-Qu
• Устройство sham acupuncture
  Patients will receive 6 weeks of sham acupuncture, 2 sessions per week, 30 min per session. The Streitberger sham acupuncture needle designed specifically for sham acupuncture trials will be used. Patients will feel the needle on the skin, but the needle actually will not puncture the skin. These 4 acupoints (He-Gu, Qu-Chi, San-Yin-Jiao, Yang-Ling-Quan) will be connected to the electrical stimulation device KWD-808I MULTI-PURPOSE Health device (Great Wall Company), but not stimulated. The needle

Первичные конечные точки

• 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 [Срок оценки: 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]

Вторичные конечные точки (8)

• The changes in quality of life assessed by European Organisation For Research And Treatment Of Cancer-Quality of Life-C30 (EORTC-QLQ-C30) questionnaires [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: At week 3 (after receiving treatment for 3 weeks)]
• Changes in inflammatory biomarkers [Срок оценки: From enrollment to end of treatment including: baseline at enrollment, after 6 weeks of treatment (end of treatment)/ enrollment]

Критерии участия

Критерии включения

• Age 18 or above
• Diagnosis of uterine (endometrial) cancer, ovarian cancer and cervical cancer
• ECOG=0-2
• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Гонконг · 1 центр

• Department of Obstetrics and Gynaecology — Гонконг

Идентификаторы

NCT: NCT06769061 · AcuCIN

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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