Feasibility of Surface Optical Guidance to Replace the Restraint Mask for External Radiotherapy of Head and Neck Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 3
- 主要终点
- Measurement patient displacement during surface-guided radiotherapy sessions
研究概览
简要总结
The goal of this clinical trial is to test the use of surface repositioning alone, without a restraint mask, during radiotherapy sessions for patients with head and neck cancer.
详细描述
In radiotherapy treatments for head and neck cancer, the use of a mask is recommended for patient immobilization. The mask completely covers the head and shoulders, ensuring reproducible positioning at every session. However, using a mask can be oppressive and anxiety-provoking for patients.
At the same time, technological developments have led us to use optical surface camera systems to position and monitor patients in the treatment room. In this way, if a movement exceeding the threshold is detected during a session, the treatment is automatically interrupted.
However, despite the use of the mask, movements are still possible underneath, and are not detected by the surface cameras.
The study's hypothesis is that the use of surface repositioning alone could guarantee reproducible treatment, as in combination with a thermoformed mask. In addition, eliminating the mask would mean greater comfort and improved quality of life for patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Patients over 18 years of age
- •Patients undergoing palliative or curative treatment for oro-rhino-laryngeal cancer
- •Patients with an indication for radiotherapy treatment, with or without complementary treatment (chemotherapy, immunotherapy), with a number of sessions between 10 and 35
- •Patients who have dated and signed an informed consent form
排除标准
- •Patients with uncontrollable movements
- •Patients under psychiatric care
- •Patients who do not understand or read French
- •Patients participating in an interventional study testing another medical intervention
- •Patients under guardianship, curatorship, safeguard of justice or deprived of liberty
- •Pregnant or breast-feeding women
- •Patients without social security coverage
研究组 & 干预措施
Surface Guided RadioTherapy without face mask
Radiotherapy sessions will be carried out using the surface camera system, replacing the restraint mask.
Self-assessment questionnaires will also be completed by healthcare professionals concerning the level of difficulty encountered during each SGRT session without mask.
Skin side effects are recorded by the radiotherapist during weekly follow-up consultations.
At the end of treatment, patients complete a patient experience questionnaire.
干预措施: Surface Guided RadioTherapy (SGRT) without mask (Procedure)
结局指标
主要结局
Measurement patient displacement during surface-guided radiotherapy sessions
时间窗: Through study completion, an average of 1 year
Average length of linear translation vector during session (measured by surface cameras) over all sessions performed
次要结局
未报告次要终点