Laser therapy for mouth ulcers caused by cancer treatment

"The effect of Low level Helium-Neon LASER therapy in the prevention and treatment of radiation induced mucositis in head and neck cancer patient

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/05/002674

Enrollment

221

Registered

2012-05-21

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Low Level Laser Therapy: Helium Neon wavelength 632.8nm power output 24mW beam spot diameter 0.6mm noncontact method Energy Density 3.0Joules per cm2 at each point of 1cm2 for 125 secon

Eligibility

Inclusion criteria

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 4.Who were scheduled to undergo concurrent chemoradiotherapy for primary HNC (i.e. oral cavity and oropharyngeal cancers 5.Willing to Participate

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
1.Oral Pain using Visual analog and Verbal Scales 2.Need for supplemental analgesic using WHO analgesic ladder 3.Dysphagia using Functional Impairment Scale 4.Weight Loss 5.Patients reported measures of Oral Mucositis using Oral Mucositis Weekly Questionnaire-Head and Neck 6.Treatment Break 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	—

Measure

Time frame

1.Oral Pain using Visual analog and Verbal Scales 2.Need for supplemental analgesic using WHO analgesic ladder 3.Dysphagia using Functional Impairment Scale 4.Weight Loss 5.Patients reported measures of Oral Mucositis using Oral Mucositis Weekly Questionnaire-Head and Neck 6.Treatment Break 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

—

Countries

India

Contacts

Public ContactAjay Prashad Gautam

Kasturba Medical College and Hospital, Manipal University

ajayphysio@gmail.com09035145083

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026