A Comparison of Acute Oral Mucositis Between Morning and Afternoon Radiotherapy in Patients Receiving Radiation Treatment for Cancer of the Head and Neck
management of therapy complications
+ radiation therapy
Carcinoma+5
+ Carcinoma, Squamous Cell
+ Neoplasms
Supportive Care Study
Summary
Study start date: August 2, 1999
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Supportive Care Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 16 to 120 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed squamous cell carcinoma of the oral cavity, pharynx (oropharynx, hypopharynx, or nasopharynx), or larynx eligible for radical radiotherapy TX, T1-4, NX, N0-3, M0 Directly visible area of mucosa including 2 or more protocol specified anatomical locations in the radical target volume At least 6 cm^2 in area irrespective of shape No M1 disease Intention to deliver radiotherapy to a radical dose without chemotherapy May have had surgical resection of the primary or neck nodes Postoperative macroscopic or microscopic residual disease that is eligible for radical radiotherapy is allowed Patients with completely resected disease who are judged to be at high risk of relapse and who are eligible for radical radiotherapy are allowed PATIENT CHARACTERISTICS: Age: 16 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Hemoglobin ≥ 10 g/dL Granulocyte count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing Fertile patients must use effective contraception HIV negative Must have normal sleeping habits (i.e., normal circadian rhythm) Must have had dental assessment and necessary prophylactic dental extractions carried out No connective tissue diseases (e.g., systemic lupus, scleroderma, mixed connective tissue disease, rheumatoid arthritis) No organic brain syndrome related to chronic alcohol excess or other cause of sufficient severity that would preclude cooperation with treatment No active uncontrolled infection No history of psychiatric or neurological disorder that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 6 months since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No prior radiotherapy to the head and neck region Surgery: See Disease Characteristics Other: No other concurrent oral hygiene regimen other than that described in the protocol No concurrent radioprotective drugs or therapy
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 14 locations
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna, CanadaOpen British Columbia Cancer Agency - Centre for the Southern Interior in Google MapsFraser Valley Centre at Surrey Memorial Hospital
Surrey, CanadaBritish Columbia Cancer Agency
Vancouver, CanadaCancerCare Manitoba
Winnipeg, Canada