Effect of Post-Operative Structured Oral Exercise therapy on swallowing function in oral cavity cancer patients: a Randomized Controlled Trial(POSE-SWALLOW)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To study the effect of post-operative Structured Oral Exercise Therapy (POSE) on swallowing function as assessed by Fiberoptic Endoscopic Evaluation of Swallowing (FEES) in oral cavity cancer patients compared to those who receive standard care (SC) at 4-6 weeks and 4-6 months post-surgery
研究概览
简要总结
This study aims to study the effect of postoperative oral exercises on swallowing function in terms of dysphagia, aspiration and oropharyngeal residues.The primary objective of the study remains to assess the effect of post-operative Structured Oral Exercise Therapy (POSE) on swallowing function as assessed by Fiberoptic Endoscopic Evaluation of Swallowing (FEES) in oral cavity cancer patients compared to those who receive standard care (SC) at 4-6 weeks and 4-6 months post-surgery. Secondary objectives include assessment of effect of POSE on functional outcomes and quality of life. All patients aged 18-75 years with ECOG PS 1-2and histopathologically proven operable squamous cell carcinoma of oral cavity patients with stage (cT1-4b N1-3 M0) undergoing resection of primary tumor with or without reconstructive procedures with curative intent and patients who can tolerate atleast a thin liquid diet by postoperative day 10 of surgery will be included in the study whereas patients with recurrent oral cavity cancers,previous history of pharyngeal or esophageal malignancy or existing difficulty in swallowing due to causes other than current malignancy eg.hemiparesis, neuromuscular disorder etc. and patients not giving informed consentwill be excluded from the study. Post-operative Structured Oral Exercise Therapy (POSE) is expected to improve swallowing function in oral cavity cancer patients compared to patients who receive standard care (SC) in post-operative period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)(—)
- 性别
- All
入选标准
- •All histopathologically proven operable SCC of oral cavity with stage (cT1-4b N1-3 M0) undergoing resection of primary tumor +/-reconstructive procedures with curative intent.
- •Patients who can tolerate atleast a thin liquid diet by postoperative day 10 of surgery.
- •ECOG PS 1-2.
排除标准
- •Recurrent oral cavity cancers.
- •Previous history of pharyngeal or esophageal malignancy.
- •Existing difficulty in swallowing due to causes other than current malignancy eg.hemiparesis, neuromuscular disorder etc.
- •Not giving informed consent.
结局指标
主要结局
To study the effect of post-operative Structured Oral Exercise Therapy (POSE) on swallowing function as assessed by Fiberoptic Endoscopic Evaluation of Swallowing (FEES) in oral cavity cancer patients compared to those who receive standard care (SC) at 4-6 weeks and 4-6 months post-surgery
时间窗: 4-6 weeks and 4-6 months post-surgery
次要结局
- 1. To study the effect of POSE on other swallowing outcomes like Eating Assessment tool (EAT-10), tube dependency, mouth opening, gargle, whistle, pain at 4-6 weeks and 4-6 months post-surgery.(2. To assess the relationship between patient-reported symptoms of oropharyngeal dysphagia (OD) using EAT-10 and objective assessment of swallowing function like aspiration-penetration score and pharyngeal residue score using FEES.)
研究者
Dr Kirti Pundir
AIIMS Jodhpur
