Comparison of the effect of Two Mouthwashes on Radiation induced Mouth Ulcers

Phase 2

Completed

• Conditions: Head and neck cancer patients scheduled to receive radiation therapy

• Registration Number: CTRI/2018/04/013362
• Lead Sponsor: DR SWIKANT SHAH

Brief Summary

The study is being conducted toassess the effectiveness of a conventionally used mouthwash over a newmouthwash in prevention as well as treatment of radiation induced oralmucositis considering that both the mouthwashes have same effect on the oralmucositis induced by radiotherapy. Currently oral mucositis is consideredto be most severe non-haematological complication affecting40% - 80% of oral cancer patients onchemotherapy and every head and neck cancer patients during the course of radiotherapy. It is observed scientifically that curcumin has anti-inflammatory, chemotherapeutic,antiangiogenic, antioxidant, chemo preventive,immunomodulation and wound healing Properties. Variouslaboratory and clinical trials has been conducted to test the effect of curcumin in reducing incidence and severity ofradiation induced oral mucositis (RIOM). The results from these studies have provided encouragingevidence regarding beneficial effect ofcurcumin in reducing RIOM. But a strong data in support of this novel substance is still lacking. In the presentstudy, we found that the use of 0.1%Curcumin not only reduced instantaneous risk of onset of RIOM by 50%, but alsodelayed the onset by 14 days at least for 50% of patients as compared to use of0.15% benzydamine mouthwash.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-26
• Study Completion: 2016-09-15
• Last Update Posted: 2018-04-13

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

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.	baseline, 1st week, 2nd week, 3rd week, 4th week, 5th week, 6th week
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.	baseline, 1st week, 2nd week, 3rd week, 4th week, 5th week, 6th week

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.	1st week, 2nd week, 3rd week, 4th week, 5th week, 6th week

Trial Locations

Locations (1)

Acharya Harihar Regional Cancer Institute; 🇮🇳 Cuttack, ORISSA, India

Acharya Harihar Regional Cancer Institute

🇮🇳Cuttack, ORISSA, India

DR SWIKANT SHAH

Principal investigator

9002579500

swikantshah@gmail.com