Using light therapy to prevent mouth ulcers in head and neck cancer patients undergoing radiation
Photobiomodulation for the Prevention of Oral Mucositis in Patients Treated With Radiotherapy for Head and Neck Cancer
This study is testing whether light therapy can help prevent painful mouth sores in head and neck cancer patients who are getting radiation treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ottawa Hospital Research Institute Academic / other |
| Drugs / interventions | Cetuximab, chemotherapy, radiation |
| Locations | 1 site (Ottawa, Ontario) |
| Trial ID | NCT04671862 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of photobiomodulation, or light therapy, to prevent severe oral mucositis in patients receiving radiotherapy for head and neck cancer. The study aims to assess the incidence of mucositis and other related symptoms during and after treatment. It is a single-arm prospective cohort study conducted at The Ottawa Hospital, where patients will receive light therapy before and during their radiation treatment. The trial seeks to establish the safety and efficacy of this technique in a Canadian context, as it is already recommended in international guidelines and widely used in Europe.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a histological diagnosis of head and neck cancer who are scheduled to receive radiotherapy.
Not a fit: Patients with gross macroscopic residual disease post-surgery or those who have had prior radiotherapy to the head and neck will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the occurrence and severity of painful mouth ulcers in patients undergoing radiation therapy for head and neck cancer.
How similar studies have performed: Previous studies have shown success with photobiomodulation in preventing mucositis in head and neck cancer patients, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ottawa, Ontario
- The Ottawa Hospital — Ottawa, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Ottawa Health Sciences Research Ethics Board
- Email: REBAdministration@toh.ca
- Phone: 613-798-5555
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.