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Light Therapy

Light Therapy for Oral Mucositis

N/A
Recruiting
Research Sponsored by Ottawa Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Intact oral mucosa (no visible ulceration, dehiscence or active infection)
Histological diagnosis of head and neck cancer of the oral cavity with no evidence of macroscopic residual disease post-surgery (R0 or R1 resection) and no gross residual lymphadenopathy in the planned PBM treatment area
Must not have
Diagnosis of photosensitive disorder (cutaneous porphyria, xeroderma pigmentosum, etc)
Prior radiotherapy to the Head and Neck including the oral or oropharyngeal mucosa.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months post radiotherapy
Awards & highlights
No Placebo-Only Group

Summary

This trial will use light therapy to try to reduce the occurrence and severity of mucositis in patients treated with radiotherapy for head and neck cancer.

Who is the study for?
This trial is for adults over 18 with head and neck cancer who've had surgery without major remaining disease, can sign a consent form, and are in good physical condition. They're planning to receive radiotherapy or chemoradiotherapy. It's not for those with prior radiation in the area, visible mouth ulcers/infections, recent chemo within 3 months, photosensitivity disorders, or use of Cetuximab.
What is being tested?
The trial tests Photobiomodulation (light therapy) as a preventive treatment against mucositis—painful mouth ulcers caused by radiotherapy—in patients with head and neck cancer. The light therapy will be applied before and during their standard radiotherapy treatments.
What are the potential side effects?
Photobiomodulation is generally considered safe but may cause some discomfort at the site of application. Since it's non-invasive there are typically no systemic side effects; however individual reactions can vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My mouth is healthy without sores or infections.
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My oral cancer surgery removed all visible cancer, and there's no large lymph node cancer in the treatment area.
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I am 18 years old or older.
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I am fully active or can carry out light work.
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I am scheduled for radiation treatment of 50 Gy or more.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a skin condition that worsens with sunlight exposure.
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I have had radiation therapy to my head or neck area.
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I still have visible cancer after surgery in the area to be treated.
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I am currently being treated with Cetuximab.
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I have not had chemotherapy in the last 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months post radiotherapy
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months post radiotherapy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Rate of occurence of radiation mucositis
Secondary study objectives
Brief Pain Inventory
EQ-5D
Head
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: PhotobiomodulationExperimental Treatment1 Intervention
Parameters: combined 633nm and 870 nm @1000mW * 1 Treatment pre radiotherapy * 3 treatments weekly during radiotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Photobiomodulation
2022
Completed Phase 3
~810

Find a Location

Who is running the clinical trial?

Ottawa Hospital Research InstituteLead Sponsor
577 Previous Clinical Trials
3,139,923 Total Patients Enrolled

Media Library

Photobiomodulation (Light Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04671862 — N/A
Oral Mucositis Research Study Groups: Photobiomodulation
Oral Mucositis Clinical Trial 2023: Photobiomodulation Highlights & Side Effects. Trial Name: NCT04671862 — N/A
Photobiomodulation (Light Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04671862 — N/A
~6 spots leftby Dec 2025
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