Head and Neck Cancer Clinical Trial
Official title:
Photobiomodulation for the Prevention of Oral Mucositis in Patients Treated With Radiotherapy for Head and Neck Cancer
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.
Status | Recruiting |
Enrollment | 25 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | The Ottawa Hospital | Ottawa | Ontario |
Lead Sponsor | Collaborator |
---|---|
Ottawa Hospital Research Institute |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of occurence of radiation mucositis | CTCAE version 2.0 | 7-14 days post radiotherapy | |
Primary | Rate of occurence of radiation mucositis | CTCAE version 2.0 | 1 month post radiotherapy | |
Primary | Rate of occurence of radiation mucositis | CTCAE version 2.0 | 3 months post radiotherapy | |
Primary | Rate of occurence of radiation mucositis | CTCAE version 2.0 | 6 months post radiotherapy | |
Primary | Rate of occurence of radiation mucositis | CTCAE version 2.0 | 12 months post radiotherapy | |
Primary | Rate of occurence of radiation mucositis | CTCAE version 2.0 | 24 months post radiotherapy | |
Secondary | Brief Pain Inventory | Pain questionnaire | 7-14 days post radiotherapy | |
Secondary | Brief Pain Inventory | Pain questionnaire | 1 month post radiotherapy | |
Secondary | Brief Pain Inventory | Pain questionnaire | 3 months post radiotherapy | |
Secondary | Brief Pain Inventory | Pain questionnaire | 6 months post radiotherapy | |
Secondary | Brief Pain Inventory | Pain questionnaire | 12 months post radiotherapy | |
Secondary | Brief Pain Inventory | Pain questionnaire | 24 months post radiotherapy | |
Secondary | Functional Assessment of Cancer Therapy - Head & Neck (FACT-HN) | Swallowing related quality of life | 7-14 days post-radiotherapy | |
Secondary | Functional Assessment of Cancer Therapy - Head & Neck (FACT-HN) | Swallowing related quality of life | 1 month post-radiotherapy | |
Secondary | Functional Assessment of Cancer Therapy - Head & Neck (FACT-HN) | Swallowing related quality of life | 3 months post-radiotherapy | |
Secondary | Functional Assessment of Cancer Therapy - Head & Neck (FACT-HN) | Swallowing related quality of life | 12 months post-radiotherapy | |
Secondary | Functional Assessment of Cancer Therapy - Head & Neck (FACT-HN) | Swallowing related quality of life | 24 months post-radiotherapy | |
Secondary | EQ-5D | General Quality of life questionnaire | 7-14 days post radiotherapy | |
Secondary | EQ-5D | General Quality of life questionnaire | 1 month post radiotherapy | |
Secondary | EQ-5D | General Quality of life questionnaire | 3 months post radiotherapy | |
Secondary | EQ-5D | General Quality of life questionnaire | 6 months post radiotherapy | |
Secondary | EQ-5D | General Quality of life questionnaire | 12 months post radiotherapy | |
Secondary | EQ-5D | General Quality of life questionnaire | 24 months post radiotherapy | |
Secondary | Radiation dermatitis | CTCAE version 5.0 | 7-14 days post radiotherapy | |
Secondary | Radiation dermatitis | CTCAE version 5.0 | 1 month post radiotherapy | |
Secondary | Radiation dermatitis | CTCAE version 5.0 | 3 months post radiotherapy | |
Secondary | Radiation dermatitis | CTCAE version 5.0 | 6 months post radiotherapy | |
Secondary | Radiation dermatitis | CTCAE version 5.0 | 12 months post radiotherapy | |
Secondary | Radiation dermatitis | CTCAE version 5.0 | 24 months post radiotherapy |
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