Photobiomodulation for the Prevention of Radiation Induced Oral Mucositis

Launched by OTTAWA HOSPITAL RESEARCH INSTITUTE · Dec 11, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the use of a treatment called photobiomodulation, or light therapy, to help prevent and reduce the severity of mouth sores (mucositis) in patients receiving radiation therapy for head and neck cancer. These sores can be very painful and make it difficult to eat and speak. The researchers want to see if using this light therapy before and during radiation can help patients feel better and have fewer complications.

To participate in this trial, you must be at least 18 years old and diagnosed with head and neck cancer. You should not have any visible signs of cancer remaining after surgery and must be planning to receive radiation therapy. The trial is currently looking for volunteers in Ottawa, and if you join, you will receive the light therapy along with your regular cancer treatment. This study is important because, although light therapy has been shown to help in other countries, it is not yet commonly used in Canada, and researchers want to ensure it is safe and effective here.

Gender

ALL

Eligibility criteria

• 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