A Comparison of Acute Oral Mucositis Between Morning and Afternoon Radiotherapy in Patients Receiving Radiation Treatment for Cancer of the Head and Neck
- Compare the toxicity of radiotherapy to the oral mucosa delivered in the morning or in
the late afternoon in patients with squamous cell carcinoma of the oral cavity, pharynx
(oro/hypo/naso), or larynx who will receive radiation treatment to a significant part
of the oral and/or oropharyngeal mucosa.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center, intended smoking behavior during therapy (smoking vs nonsmoking), and
planned total radiotherapy dose.
Patients are randomized to receive radiotherapy once daily, 5 days a week, at one of two of
the following times of the day:
- Arm I: Patients receive radiotherapy between 8 and 10 AM (local time).
- Arm II: Patients receive radiotherapy between 4 and 6 PM (local time). Treatment
continues for 5-8 weeks, depending on planned total radiotherapy dose, in the absence
of unacceptable toxicity or disease progression.
Toxicity is assessed at baseline, at the first fraction of radiotherapy, weekly during
treatment, weekly until mucositis has peaked and is improving, and then every 2 weeks until
mucositis has improved to less than grade 2.
Quality of life is assessed at baseline, weekly during treatment and until toxicity has
peaked and is improving, every 2 weeks until toxicity is less than grade 2 mucositis, and
then at each follow-up visit until week 24.
Patients are followed at weeks 2-3, 6-8, 12, and 24 and then annually for 3 years.
PROJECTED ACCRUAL: A total of 216 patients (108 per treatment arm) will be accrued for this
Allocation: Randomized, Primary Purpose: Supportive Care
Georg A. Bjarnason, MD, FRCPC
Edmond Odette Cancer Centre at Sunnybrook
United States: Federal Government