Evaluation of an Active Swallowing Rehabilitation on Quality of Life of Patients Treated by Radiotherapy for Head and Neck Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 183
- 试验地点
- 21
- 主要终点
- Proportion of patients experiencing a clinically relevant improvement defined as a decrease of at least 10 points of the score HNSW ( 6 months after radiotherapy compared with the score before radiotherapy
研究概览
简要总结
Toxicity and mainly dysphagia have increased in head and neck cancers as chemoradiation indications have risen over the last decade, leading to a significant loss of quality of life for patients. Recently, many retrospective studies and two evidence-based and systematic reviews on strategies to reduce radiation-induced dysphagia have suggested a trend toward benefit for a preventive swallowing exercise program.
The main hypothesis of this study is that an early active swallowing therapy can improve the Quality of Life (QoL) of patients treated by radiotherapy for head and neck cancer.
The study will be a randomized controlled, open-label, multicentric phase III clinical trial comparing early active swallowing therapy versus non specific swallowing management (usual care).
详细描述
Patients in both groups will receive dietary and postural advice from the treating physician. Patients in the experimental group will be treated with an early active swallowing therapy including a consultation with a speech and language therapist twice a week and a detailed program of swallowing auto-exercises twice a day, from the start to one month after the end of radiotherapy. All speech therapists will be given precise guidelines based on the current state of the art and knowledge. All patients will be analyzed in intent-to-treat.
Two ancillary studies will complete this global concept of the evaluation and prediction of severe alteration of Quality of Life (QoL) and Dysphagia.
- A first study will evaluate videoradioscopy. Its objectives are to evaluate the ability of videoradioscopy at 3 months to predict poor QoL at 6 and 12 months, to identify videoradioscopic predictors of severe dysphagia, asymptomatic aspirations, cricopharyngeal stenoses and active swallowing rehabilitation efficiency. Each patient of both arms of the main study will undergo a videoradioscopy before the beginning of the radiation delivery (baseline evaluation), and at 3 and at 12 months. Data analysis will be centralized and will concern: APS (Aspiration and Penetration Scale) score, residue, Defective Laryngeal elevation, pharyngoesophageal sphincter dysfunction. Data will be correlated to the parameters of the main study in order to establish predictive models.
- A second ancillary study will evaluate the dose-volume histograms of radiotherapy. The objectives are to identify predictors of dysphagia and of active swallowing rehabilitation efficiency, and to establish "2D" and "3D" predictive models of dysphagia. Imaging and dosimetric data (IMRT (Intensity Modified RadioTherapy) planning) and dose-volume histogram will be collected from the patients of the main clinical trial. Analysis will be centralized. Data will be correlated to the parameters of the main study in order to establish predictive models.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patient treated for histologically proven head and neck cancer (oral cavity, oropharynx, or hypopharynx cancer) of stages I-IV or larynx cancer of stages II-IV, all histologic type, without distant metastasis
- •Indication of curative radiotherapy alone or associated to chemotherapy or targeted therapy, without planned surgery
- •WHO (World Health Organization) Performance Status 0, 1 or 2
- •Sufficient cognitive capacities to complete a QoL questionnaire (evaluation by the physician at inclusion)
- •Written informed consent
- •Patients with health insurance
排除标准
- •Previous radiotherapy or surgery of the upper aerodigestive tract
- •Cancer of paranasal sinuses or nasopharynx or skull base
- •Medical history of nervous system disease associated to significant sequelae in terms of dysphagia
- •Pregnant or breast-feeding woman
- •Patient under guardianship, trusteeship or judicial protection
结局指标
主要结局
Proportion of patients experiencing a clinically relevant improvement defined as a decrease of at least 10 points of the score HNSW ( 6 months after radiotherapy compared with the score before radiotherapy
时间窗: 6 months after radiotherapy
HNSW = Head and Neck Swallowing Questionnaire
次要结局
- Body Mass index (BMI)(Baseline, 3, 6 and 12 months after radiotherapy)
- Number of treatment interruptions(12 months after radiotherapy)
- EORTC QLQ-C30 score(Baseline, 3, 6 and 12 months after radiotherapy)
- EORTC H&N35 score(Baseline, 3, 6 and 12 months after radiotherapy)
- Overall duration of enteral nutrition(12 months after radiotherapy)
- Swallowing specific Quality of Life (SWAL-QOL) score(Baseline, 3, 6 and 12 months after radiotherapy)
- MFI-20 score(Baseline, 3, 6 and 12 months after radiotherapy)
- Functional Oral Intake Scale (FOIS)(Baseline, 3, 6 and 12 months after radiotherapy)
- Number of patients with adverse events(End of radiotherapy (an average of 2 months after baseline), 1, 3, 6 and 12 months after radiotherapy)
- Number of patients with aspiration and penetration determined by APS (Aspiration and Penetration Scale) scoring(Baseline, 3, 6 and 12 months after radiotherapy)
- Rate of survival without recurrence(12 months after radiotherapy)
- Total treatment duration(12 months after radiotherapy)
- Rate of global survival(12 months after radiotherapy)