Bioadhesive herbal mouthwashes for management of radiation induced oral mucositis in Head & Neck cancer patients.

Phase 2

• Conditions: Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx

• Registration Number: CTRI/2023/06/054012
• Lead Sponsor: Dr Jayapriya T

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Patients with histologically confirmed diagnosis of carcinoma of the oral cavity undergoing radiotherapy 5 times/week for 6-7 weeks.

2. Mucositis affecting any oral anatomical structures diagnosed according to WHO criteria.

Exclusion Criteria

1. Patients with oral mucositis and undergoing radiotherapy for cancers other than head and neck. 2. Patients receiving other prophylactic interventions for oral mucositis.

3. Patients who does not give consent for participation or refuse to follow up

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1) Reduction in severity of oral mucositis assessed using the WHO grading system <br/ ><br>2) Reduction in pain associated with oral mucositis assessed using the VAS scale.Timepoint: Visit 1- At the end of the 2nd week/ Day 1 (±1day) <br/ ><br>Visit 2- At the end of the 3rd week/ Day 8 (±1day) <br/ ><br>Visit 3- At the end of the 4th week/ Day 15 (±1day) <br/ ><br>Visit 4- At the end of the 5th week/ Day 22 (±1day) <br/ ><br>Visit 5- At the end of the 6th week/ completion of radiotherapy Day 29 (±1day) <br/ ><br>Visit 6- 1 week Post radiotherapy Day 36 <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
Adverse effects if any.Timepoint: Visit 1- At the end of the 2nd week/ Day 1 (±1day) <br/ ><br>Visit 2- At the end of the 3rd week/ Day 8 (±1day) <br/ ><br>Visit 3- At the end of the 4th week/ Day 15 (±1day) <br/ ><br>Visit 4- At the end of the 5th week/ Day 22 (±1day) <br/ ><br>Visit 5- At the end of the 6th week/ completion of radiotherapy Day 29 (±1day) <br/ ><br>Visit 6- 1 week Post radiotherapy Day 36 (±1day) <br/ ><br>