A study to understand the effectiveness of carrying out swallowing exercises during radiation therapy for head and neck cancer
- Registration Number
- CTRI/2020/09/028037
- Lead Sponsor
- Ms Janet Jaison Varghese
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1)An existing diagnosis of stage I, II, III or IVA non-metastatic squamous cell carcinoma of the head & neck region.
2)CRT/RT with a curative intent as the expected mode of intervention
3)Karnofsky Performance Status of >70.
4)Intermediate reading and writing proficiency in Kannada/Malayalam.
5)Able to be cognitively, mentally, and legally capable of making independent decisions regarding personal medical care
Exclusion criteria for Intervention Group and Control Group:
1)Patients who are planned for surgical resection of the malignancy.
2)An existing diagnosis of dysphagia unrelated to his/her current diagnosis of cancer
3)Cancer related dysphagia of moderate to higher severity at baseline
4)Metastatic patients, and those receiving treatment with a non-curative intent.
5)Prior treatment for any cancers, including cancers of the head & neck region.
6)Patients with a history of spine surgery or any other neurosurgical procedures
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Swallowing outcome as assessed by Mann Assessment of swallowing abilities- Cancer (MASA-C) <br/ ><br>Timepoint: oBaseline Assessment <br/ ><br>oAt the end of CRT/RT <br/ ><br>o1 month after conclusion of CRT/RT <br/ ><br>o3 months after conclusion of CRT/RT <br/ ><br>o6 months after conclusion of CRT/RT <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method