The Effectiveness of Laserpuncture on Chemotherapy-induced Leucopenia and Quality of Life in Head and Neck Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Leukocyte Count
研究概览
简要总结
The goal of this clinical trial is to evaluate if laserpuncture (laser acupuncture) can reduce leucopenia caused by chemotherapy and improve the quality of life in patients with head and neck cancer. The main questions it aims to answer are:
- Does laserpuncture reduce the incidence of chemotherapy-induced Leucopenia ?
- Does laserpuncture improve quality of life in these patients?
Researchers will compare patients receiving laserpuncture therapy to a control group receiving sham laserpuncture to see if the intervention has a beneficial effect.
Participants will:
- Undergo six sessions of laserpunktur or sham laserpuncture during chemotherapy
- Have leukocyte counts and absolute neutrophil counts measured before and 7-14 days after chemotherapy
- Complete quality of life assessments using EORTC QLQ-C30 and EORTC QLQ-H&N35 questionnaires
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The participants and the outcome assessors will be blinded to group allocation
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients with head and neck cancer, aged 18-60 years.
- •Head and neck cancer patients diagnosed through histopathological examination, with cancer stages II to IV.
- •Head and neck cancer patients undergoing chemotherapy with platinum-based chemotherapy drugs combined with 5-Fluorouracil, in the first treatment cycle.
- •Leukocyte count greater than 5000/mm³.
- •Patients who have signed informed consent and are willing to participate in the study until completion.
- •Normal Mini-Mental State Examination (MMSE) score (27-31).
排除标准
- •Patients with cancer lesions, ulcers, acute dermatitis, or exacerbation of chronic skin diseases at the selected acupuncture points.
- •Patients with deformities or anatomical abnormalities of the ear.
- •Patients with fever (body temperature >38ºC).
- •Patients with hemodynamic instability (patient vital signs outside the normal limits. Normal vital signs include axillary temperature of 36.5 - 37.5ºC, systolic blood pressure 102 - 131 mmHg, diastolic blood pressure 61 - 83 mmHg, pulse rate 60 - 100 beats/minute. Unstable if respiratory rate is above 25 breaths/minute or SpO2 < 90%).
- •Patients with a history of allergy to laser irradiation (skin hypersensitivity due to exposure to specific light).
- •- Patients with a history of uncontrolled seizures or epilepsy.
研究组 & 干预措施
Investigation Group
The laser acupuncture
干预措施: The laser acupuncture (Device)
Control Group
The sham laser acupuncture
干预措施: Sham Laser acupuncture (Device)
结局指标
主要结局
Leukocyte Count
时间窗: Before therapy, between 7-14 day after chemoterapy
Leukocyte count is the measure of the number of white blood cells (leukocytes) present in the blood
Absolute Neutrophil Count
时间窗: Before therapy, between 7-14 day after chemoterapy
The Absolute Neutrophil Count (ANC) is a laboratory measure of the number of neutrophils, a type of white blood cell that plays a critical role in fighting infection, present in the blood.
European Organization of Research and Treatment of Cancer Quality of Life Questionnaire- Core 30 questionnaire
时间窗: Before therapy, between 7-14 day after chemoterapy
Self-reported questionnaire to assess the quality of life of cancer patients.
European Organization of Research and Treatment of Cancer Quality of Life Questionnaire Heand &Neck 35 questionnaire
时间窗: Before therapy, between 7-14 day after chemoterapy
Self-reported questionnaire to assess quality of life specific to patients with head and neck cancer.
次要结局
未报告次要终点
研究者
Resti Victoria Fanggidae
Principal Investigator
Indonesia University