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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months post radiotherapy

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months post radiotherapy

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of occurence of radiation mucositis

Secondary outcome measures

Brief Pain Inventory

EQ-5D

Head

+1 more

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

2016

Completed Phase 3

~630

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ottawa Hospital Research InstituteLead Sponsor

561 Previous Clinical Trials

2,785,669 Total Patients Enrolled

Media Library

Photobiomodulation (Light Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04671862 — N/A

Head and Neck Cancers Research Study Groups: Photobiomodulation

Head and Neck Cancers 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial still accepting participants?

"Indeed, the clinicaltrials.gov web page clarifies that this medical experiment is still recruiting patients. It was initially posted on June 1st 2021 and has been updated as recently as September 9th 2021. 25 subjects are needed from one medical site to complete the trial."

Answered by AI

To what extent has enrollment progressed in this trial?

"Indeed, according to the clinicaltrials.gov website, this research trial is currently enrolling participants. The protocol was initially published on June 1st 2021 and has recently undergone a modification as of September 9th 2021. 25 patients must be gathered from one medical facility for participation in the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Photobiomodulation for the Prevention of Radiation Induced Oral Mucositis

2021. "Photobiomodulation for the Prevention of Radiation Induced Oral Mucositis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04671862.

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