Comparison of the effect of Two Mouthwashes on Radiation induced Mouth Ulcers
Phase 2
Completed
- Conditions
- Health Condition 1: null- Head and neck cancer patients scheduled to receive radiation therapy
- Registration Number
- CTRI/2018/04/013362
- Lead Sponsor
- DR SWIKANT SHAH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 74
Inclusion Criteria
1.Patient histo-pathologically confirmed to have head and neck cancer scheduled for Radio therapy.
2.Minimum period of radiotherapy - 4-6 weeks with radiation dose 0f >=50Gy
3.Patients who are able to use mouthwash.
4.Patient with KARNOFSKY PERFORMANCE STATUS SCALE more than 60%
Exclusion Criteria
1.Any physically handicapped condition which can affect the use of mouthwash
2.Patients who are on any other oral related medicine/mouthwash
3.Pregnant patients
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To assess the oral mucosal status prior to the onset of Radiotherapy using various scales for assessing Oral Mucositis. <br/ ><br> <br/ ><br>2.To assess the change in Oral Mucositis in both study groups at 1st week, 2nd week, 3rd week,4th week, 5th week and 6th week of radiotherapy after using the mouthwash. <br/ ><br> <br/ ><br> <br/ ><br>Timepoint: baseline, 1st week, 2nd week, 3rd week, 4th week, 5th week, 6th week <br/ ><br>
- Secondary Outcome Measures
Name Time Method To check patient compliance with the mouthwashes for both the study groups at 1st week, 2nd week, 3rd week,4th week,5th week and 6th week.Timepoint: 1st week, 2nd week, 3rd week, 4th week, 5th week, 6th week