Status:
RECRUITING
Photobiomodulation for the Prevention of Radiation Induced Oral Mucositis
Lead Sponsor:
Ottawa Hospital Research Institute
Conditions:
Mucositis Oral
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 occ...
Detailed Description
Introduction: 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04671862
Start Date
June 1 2021
End Date
December 31 2025
Last Update
February 21 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6