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Photobiomodulation for the Prevention of Radiation Induced Oral Mucositis

Head and Neck Cancer | Radiation Dermatitis | Mucositis Oral

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.

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Conditions de participation

  • Sexe:

    ALL

  • Âges admissibles:

    18 and up

Critères de participation

Inclusion Criteria:

* Age ≥ 18 years of age
* Willing and able to understand and sign informed consent form approved by the institutional review board (IRB)
* 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
* Planned treatment with radiotherapy or chemoradiotherapy to a dose of ≥ 50 Gy
* ECOG Performance Status of 0 or 1
* Intact oral mucosa (no visible ulceration, dehiscence or active infection

Exclusion Criteria:

* Gross macroscopic residual disease post surgery (R2 resection) or gross residual lymphadenopathy in the planned PBM treatment area
* Prior radiotherapy to the Head and Neck including the oral or oropharyngeal mucosa.
* Prior cytotoxic chemotherapy in the last 3 months
* Diagnosis of photosensitive disorder (cutaneous porphyria, xeroderma pigmentosum, etc)
* Concurrent administration of Cetuximab

Lieu de l'étude

The Ottawa Hospital
The Ottawa Hospital
Ottawa, Ontario
Canada

Contactez l'équipe d'étude

Backup Contact

Kristopher Dennis, MD PhD

[email protected]
613-737-7700
Primary Contact

Marc Gaudet, MD MSc MHA

[email protected]
613-737-7700
Étude parrainée par
Ottawa Hospital Research Institute
Participants recherchés
Plus d'informations
ID de l'étude: NCT04671862