Oral Mucositis in Patients Receiving Radiation Therapy for Cancer of the Mouth, Pharynx, or Larynx
Condition: Head and Neck Cancer; Oral Complications
MeSH terms: Mucositis; Stomatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation
      therapy at different times of the day may affect the chance of developing side effects such
      as mucositis.

      PURPOSE: Randomized phase III trial to compare the incidence of mucositis in patients who
      have cancer of the mouth, pharynx, or larynx, who are receiving radiation therapy in either
      the morning or afternoon.
    

Detailed description: 
      OBJECTIVES:

        -  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
      study.
    

Intervention name(s): management of therapy complications; radiation therapy
Intervention type(s): Procedure; Radiation
Allocation: Randomized
Primary purpose: Supportive Care
Keywords: oral complications; stage I squamous cell carcinoma of the lip and oral cavity; stage II squamous cell carcinoma of the lip and oral cavity; stage III squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the lip and oral cavity; recurrent squamous cell carcinoma of the lip and oral cavity; stage I squamous cell carcinoma of the oropharynx; stage II squamous cell carcinoma of the oropharynx; stage III squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the oropharynx; recurrent squamous cell carcinoma of the oropharynx; stage I squamous cell carcinoma of the nasopharynx; stage II squamous cell carcinoma of the nasopharynx; stage III squamous cell carcinoma of the nasopharynx; stage IV squamous cell carcinoma of the nasopharynx; recurrent squamous cell carcinoma of the nasopharynx; stage I squamous cell carcinoma of the hypopharynx; stage II squamous cell carcinoma of the hypopharynx; stage III squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the hypopharynx; recurrent squamous cell carcinoma of the hypopharynx; stage I squamous cell carcinoma of the larynx; stage II squamous cell carcinoma of the larynx; stage III squamous cell carcinoma of the larynx; stage IV squamous cell carcinoma of the larynx; recurrent squamous cell carcinoma of the larynx