A comparative, randomized single blind prospective study to find out the impact of early dysphagia intervention on swallowing function in head and neck cancer patients treated with intensity modulated radiation therapy (IMRT) or image guided radiation therapy (IGRT)with or without chemotherapy.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Head and neck cancer patients with or without dysphagia .
研究概览
简要总结
StudyTitle
Title of the study: Randomized prospective study to find out the impact ofearly dysphagia intervention on swallowing function in head and neck cancerpatients treated with intensity modulated radiation therapy (IMRT) or image guided radiation therapy(IGRT)with or without chemotherapy
Objectives
To find out the impact of early dysphagia intervention onswallowing function
Design and Outcome
Thisstudy is a randomized Prospective study where Head and neck cancer patients willbe randomly allocated to either of the groups with or without dysphagia intervention.
Interventions and duration
GROUP A-Dysphagiaassessment (clinical evaluation + FEES) with the intervention will be providedfrom the day of the onset of radiation therapy.
GROUPB – Dysphagia assessment (clinical evaluation + FEES) without the interventionwill be provided from the day of the onset of radiation therapy.
Swallowingassessment will be done three times for each patient, in the 1stweek, after 3 & 6 months of radiation. Patient will come for routine followup as per departmental policy at 2 weeks, 1, 3 & 6 months after completionof radiation. Patients will be reinforced to continue regular dysphagiaexercises, at least twice a day and 4 days in a week.
Radiationwill be delivered with IMRT or IGRT, 5 days a week for 6-7 weeks along with orwithout concurrent chemotherapy.
Sample size and Population
50 Head and neck cancer patients, 25 patients group A &25 patients in group B.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 19.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion Criteria 1.Patients 19 to 85 years of age, either sex.
- •2.Head & Neck sites (Nasopharynx, Oral Cavity, Oropharynx, Hypopharynx, Larynx) 3.Confirmed histopathological diagnosis 4.Must undergo pre-treatment evaluation of tumor extent and tumor measurement.
- •5.Nutritional and general physical condition must be considered compatible with treatment 6.No prior radiotherapy to the head and neck; no previous chemotherapy 7.No prophylactic use of amifostine or pilocarpine 8.No other malignancy in the rest of the body 9.No evidence of distant metastasis 10.No major medical or psychiatric illness.
排除标准
- •1.Patients having tracheostomy tube 2.Second malignancy of head and neck region 3.Previously radiated patients 4.Psychiatric and neurological conditions involving brain and cervical spine 5.Unable to comprehend the function and use of the rehabilitation exercises 6.Patient not agreeing for follow up.
- •7.Swallowing problem other than due to malignancy.
- •8.Age > 65 and < 18 Years.
结局指标
主要结局
Head and neck cancer patients with or without dysphagia .
时间窗: Head and neck cancer patients with or without dysphagia.
次要结局
- Not Applicable(Not Applicable)