Effectiveness of Manual Acupuncture as an Adjuvant Therapy for Head and Neck Cancer Patients Undergoing Chemoradiation at the Radiation Oncology Polyclinic of RSUPN DR. Cipto Mangunkusumo
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Absolute Neutrophil Count (ANC)
研究概览
简要总结
The goal of this clinical trial is to assess whether manual acupuncture (MA) is more effective than sham acupuncture in improving leukocyte count and reducing cancer-related fatigue (CRF) in head and neck cancer (HNC) patients undergoing chemoradiation therapy (CRT).
The main questions it aims to answer are:
- Does MA, compared to sham acupuncture, increase leukocyte and absolute neutrophil count (ANC) during CRT?
- Does MA, compared to sham acupuncture, reduce the severity of CRF as measured by the Visual Analogue Scale-Fatigue (VAS-F)?
- Does MA, compared to sham acupuncture, improve quality of life as measured by the EORTC QLQ-C30 questionnaire?
Participants will:
- Be adult patients with head and neck cancer who have completed induction chemotherapy and are undergoing CRT
- Be screened based on inclusion and exclusion criteria, including normal INR and platelet count above 25,000/mm³
- Be randomly assigned to either the MA group or sham group using Park sham needle
- Receive acupuncture at points ST36, SP6, CV4, and CV6 three times per week for seven sessions (total 21 sessions)
- Be evaluated for leukocyte count, ANC, fatigue (VAS-F), and quality of life (EORTC QLQ-C30) at baseline and at weekly intervals during therapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Blinding will be applied to participants and outcome assessors. Group allocation will not be disclosed to them to minimize assessment bias.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects diagnosed with head and neck cancer (HNC) based on histopathological examination, who have completed induction chemotherapy and are scheduled to undergo radiotherapy.
- •Subjects aged ≥18 years.
- •Subjects willing to participate in this study and provide written informed consent.
- •Subjects with a Mini Mental State Examination (MMSE) score ≥
- •Subjects with oxygen saturation ≥95% on room air.
- •Subjects with stage III or IVA cancer.
- •Subjects receiving a radiation dose of 66-70 Gy.
排除标准
- •Subjects with severe comorbidities such as chronic kidney failure, metastatic liver cirrhosis, or heart disease.
- •Subjects currently undergoing other therapies that may affect leukocyte counts, such as immunomodulatory therapy or high-dose corticosteroid use.
- •Subjects who are still smoking or consuming alcohol.
- •Subjects with blood clotting disorders or those currently taking anticoagulants, confirmed by laboratory results: neutrophils <1,000/mm³, platelets <25,000/mm³, INR >2.0, or partial thromboplastin time >20 seconds.
- •Pregnant or breastfeeding women.
研究组 & 干预措施
Intervention Group
Manual Acupuncture
干预措施: Manual Acupuncture (Device)
Control group
Sham Manual Acupuncture
干预措施: Sham Manual Acupuncture (Device)
结局指标
主要结局
Absolute Neutrophil Count (ANC)
时间窗: Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 , Week 7
ANC (cells/µL) will be measured to assess neutrophil recovery and myelosuppression status.
Leukocyte Count
时间窗: Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 , Week 7
Leukocyte count (cells/µL) will be measured through laboratory tests to evaluate changes in white blood cell levels.
Leukocyte Count
时间窗: Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 , Week 7
Leukocyte count (cells/µL) will be measured through laboratory tests to evaluate changes in white blood cell levels.
Absolute Neutrophil Count (ANC)
时间窗: Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 , Week 7
ANC (cells/µL) will be measured to assess neutrophil recovery and myelosuppression status.
次要结局
- Visual Analogue Scale - Fatigue (VAS-F)(Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 , Week 7)
- Visual Analogue Scale - Fatigue (VAS-F)(Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 , Week 7)
- EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire)(Time Frame: Baseline, Week 7)
研究者
Thia Wanudyo Hutami
Medical Doctor
Indonesia University