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Photobiomodulation for the Prevention of Radiation Induced Oral Mucositis

NCT04671862 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2024-02-21

No results posted yet for this study

Summary

Radiotherapy for head and neck cancer can cause severe mucositis (ulcers in the mouth) and pain. Photobiomodulation (Light therapy) will be used before and during radiotherapy to try to reduce the occurence and severity of mucositis in patients treated with radiotherapy for head and neck cancer

Previous studies in head and neck cancer patients have shown that photobiomodulation (light therapy) can prevent mucositis. There are currently no centers in Canada using this technique in routine practice, but this is recommended in International guidelines and widely used in Europe. The investigators therefore wish to implement this technique in Ottawa under the umbrella of a clinical trial to insure its safety and efficacy in a Canadian context.

Conditions

Interventions

DEVICE

Photobiomodulation

Parameters: combined 633nm and 870 nm @1000mW * 1 Treatment 4J continuous prior to RT. (Within 14 days of RT start) * 3 treatments weekly during RT (6 J at 12 Hz, 80% duty cycle)

Sponsors & Collaborators

  • Ottawa Hospital Research Institute

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04671862 on ClinicalTrials.gov