Effect of speech and swallow therapy on quality of life and speech intelligibility in patients with squamous cell carcinoma of tongue – A randomized control study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- To assess the effect of speech and swallow therapy on quality of life and speech intelligibility in patients undergoing wide local excision for squamous cell carcinoma of tongue with or without flap reconstruction.
研究概览
简要总结
Head and neck cancer is a major health problem in
the Indian subcontinent. Cancer outcomes are usually measured in terms of disease free survival, overall survival rate and other similar variables. Studies have shown that it is also vital to include the impact of the cancer and its treatment on patient’s quality of life as they have a role in survival. The European Organisation for Research & Treatment of Cancer questionnaire will serve as a tool to assess the multidimensional aspects of quality of life in these patients.
Intelligibility and articulation play a major role in determining the quality of speech. Impairments in pronunciation and speech are common in people with oral cavity and oropharyngeal cancers before and after surgery. Speech and swallow therapy in the post-op period may help to improve the intelligibility and thereby achieve a better quality of life in these patients. But the role of speech therapy is debatable. Hence, the study is being carried out to assess the impact of speech and swallow therapy on the quality of life and voice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with biopsy showing squamous cell carcinoma of tongue belonging to cT1 – 4a, N0 – 3, M0 receiving glossectomy as primary treatment, with or without flap reconstruction, belonging to both genders and age groups between 18 and 70 yrs will be included.
排除标准
- •1.Patients with advanced lesions cT4a with total tongue involvement 2.Recurrent disease 3.Prior history of surgery / chemoradiotherapy 4.Patients not willing for surgery 5.Not fit for surgery 6.Patients with distant metastasis.
结局指标
主要结局
To assess the effect of speech and swallow therapy on quality of life and speech intelligibility in patients undergoing wide local excision for squamous cell carcinoma of tongue with or without flap reconstruction.
时间窗: 15 days, 1 month, 3 months, 6 months
次要结局
未报告次要终点