aser therapy for mouth ulcers caused by cancer treatment

Phase 3

Completed

• Conditions: Health Condition 1: null- Head and Neck Cancer patients receiving Radiation/Concurrent Chemoradiotherapy

• Registration Number: CTRI/2012/05/002674
• Lead Sponsor: Department of Atomic EnergyBoard of Research in Nuclear Sciences Government of India

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 221

Inclusion Criteria

1.Who were newly diagnosed primary Head and Neck Cancer

2.Who were >=18 years of age

3.Eastern Cooperative Oncology Group (ECOG) performance Score <= 2

4.Who were scheduled to undergo concurrent chemoradiotherapy for primary HNC (i.e. oral cavity and oropharyngeal cancers

5.Willing to Participate

Exclusion Criteria

1.Trismus because difficulty in delivering laser beam to the selected sites in oral cavity

2.ECOG performance Score > 2 because of self-care issue in maintaining oral hygiene

3.Any medically compromised conditions which impair wound healing (e.g. diabetes)

4.Any distant metastasis

5.Any history of prior radiation or neo-adjuvant chemotherapy for HNC

6.Patients not receiving high dose radiation to any part of the oral cavity

7.Patients not willing to participate in the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Severity of Mucositis using European Organization for Research and Treatment of Cancer (RTOG/ EORTC) scoring systemTimepoint: Daily, From Baseline till the end of Concurrent Chemoradiotherapy

Secondary Outcome Measures

Name	Time	Method
1.Oral Pain using Visual analog and Verbal Scales <br/ ><br>2.Need for supplemental analgesic using WHO analgesic ladder <br/ ><br>3.Dysphagia using Functional Impairment Scale <br/ ><br>4.Weight Loss <br/ ><br>5.Patients reported measures of Oral Mucositis using Oral Mucositis Weekly Questionnaire-Head and Neck <br/ ><br>6.Treatment Break <br/ ><br>7.Quality of life using Functional Assessment of Cancer Treatment- Head and Neck Questionnaire (Version 4Timepoint: 1,2 and 3 daily,4 and 5 weekly,6 at the end of concurrent chemoradiotherapy,7 at the baseline, at the end and after one month follow up of Concurrent chemoradiotherapy