Acute and Long-term Impact of Cancer Treatment on Quality-of-life, Physical and Cognitive Function of Head and Neck Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Quality of life (long-term)
研究概览
简要总结
Head and Neck Squamous Cell Carcinoma (HNSCC) is the 6th most common cancer. Most cases are diagnosed in locally advanced stages, with treatment involving multimodal approach with combinations of radiotherapy, surgery and chemotherapy. The aggressive nature of HNSCCs and treatment modalities are associated with important acute and late toxicities that often promote temporary or definitive treatment interruption and may compromised the capability to tolerate subsequent treatments. Thus, the aim of this study is to analyze the acute and long-term impact of cancer treatment on quality of life, physical and cognitive function of HNSCC patients diagnosed with a locally advanced disease.
详细描述
Potential cases will be identified at the multidisciplinary head and neck group meeting. If the case meets eligibility an informed consent will be presented to the patient. Interested participants will be scheduled for baseline assessment before the beginning of treatment (M0). At the end of CRT patients will be submitted to a second assessment (M1). Follow-up assessments will occur 16th to 18th weeks after the treatment is completed (M2). Patients proposed to surgery or induction chemotherapy will also be submitted to an additional assessment before the beginning of CRT (Mc / Mic).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 older than 18 years.
- •Diagnosis of locally advanced head and neck cancer (oral cavity, oropharynx, hypopharynx, larynx), stage III-IVB.
- •Proposed for primary treatment with curative intent - surgery or induction chemotherapy before chemoradiotherapy (CRT) or CRT alone.
排除标准
- •Synchronous tumors or other comorbidities with associated uncontrolled symptoms.
- •Inability to provide informed consent.
- •Expected inability to fulfil the propose schedule and follow-up.
结局指标
主要结局
Quality of life (long-term)
时间窗: Change of global quality of life score from baseline to 4 months after the treatment is completed
Global quality of life score evaluated by EORTC QLQ-C30 questionnaire (range in score from 0 to 100, high score represents a high level of functioning)
Quality of life (acute)
时间窗: Change of global quality of life score from baseline to the end of treatment
Global quality of life score evaluated by EORTC QLQ-C30 questionnaire (range in score from 0 to 100, high score represents a high level of functioning)
次要结局
- Fatigue (acute)(Change of fatigue score from baseline to the end of treatment)
- Body composition (long-term)(Change of body mass index from baseline to 4 months after the treatment is completed)
- Cognitive function (acute)(Change of MoCA score from baseline to the end of treatment)
- Fatigue (long-term)(Change of fatigue score from baseline to 4 months after the treatment is completed)
- Dysphagia (long-term)(Change of FOIS score from baseline to 4 months after the treatment is completed)
- Body composition (acute)(Change of body mass index from baseline to the end of treatment)
- Dysphagia (acute)(Change of FOIS score from baseline to the end of treatment)
- Handgrip maximal isometric muscle strength (long-term)(Change of muscle strength from baseline to 4 months after the treatment is completed)
- Physical function (acute)(Change of distance from baseline to the end of treatment)
- Capability of tolerating subsequent treatments(2 years follow-up)
- Social functioning (acute)(Change of body mass index from baseline to the end of treatment)
- Social functioning (long-term)(Change of body mass index from baseline to 4 months after the treatment is completed)
- Nutritional status (acute)(Change of PG-SGA total score from baseline to the end of treatment)
- Nutritional status (long-term)(Change of PG-SGA total score from baseline to 4 months after the treatment is completed)
- Cognitive function (long-term)(Change of MoCA score from baseline to 4 months after the treatment is completed)
- Sit-to-stand test (acute)(Change of repetitions from baseline to the end of treatment)
- Physical function (long-term)(Change of distance from baseline to 4 months after the treatment is completed)
- Quadriceps maximal isometric muscle strength (acute)(Change of muscle strength from baseline to the end of treatment)
- Sit-to-stand test (long-term)(Change of repetitions from baseline to 4 months after the treatment is completed)
- Overall survival(2 years follow-up)
- Handgrip maximal isometric muscle strength (acute)(Change of muscle strength from baseline to the end of treatment)
- Quadriceps maximal isometric muscle strength (long-term)(Change of muscle strength score from baseline to 4 months after the treatment is completed)
- Progression free survival(2 years follow-up)