Oral Mucositis in Patients Receiving Radiation Therapy for Cancer of the Mouth, Pharynx, or Larynx

Head and Neck Cancer Clinical Trial

Official title:

A Comparison of Acute Oral Mucositis Between Morning and Afternoon Radiotherapy in Patients Receiving Radiation Treatment for Cancer of the Head and Neck

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004234
• Other study ID #: HN3
• Secondary ID: CAN-NCIC-HN3CDR0
• Status: Completed
• Phase: Phase 3
• Start date: August 2, 1999
• Est. completion date: February 10, 2009

Study information

• Verified date: April 2020
• Source: Canadian Cancer Trials Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: February 10, 2009
• Est. primary completion date: March 11, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Mucositis
• Oral Complications
• Stomatitis

Intervention

Procedure:
• management of therapy complications

Radiation:
• radiation therapy

Locations

Country	Name	City	State
Canada	CHUS-Hopital Fleurimont	Fleurimont	Quebec
Canada	Margaret and Charles Juravinski Cancer Centre	Hamilton	Ontario
Canada	British Columbia Cancer Agency - Centre for the Southern Interior	Kelowna	British Columbia
Canada	Cancer Care Ontario-London Regional Cancer Centre	London	Ontario
Canada	McGill Cancer Centre	Montreal	Quebec
Canada	Ottawa Regional Cancer Centre	Ottawa	Ontario
Canada	Centre Hospitalier Universitaire de Quebec	Quebec City	Quebec
Canada	Saskatoon Cancer Centre	Saskatoon	Saskatchewan
Canada	Newfoundland Cancer Treatment and Research Foundation	St. Johns	Newfoundland and Labrador
Canada	Fraser Valley Centre at Surrey Memorial Hospital	Surrey	British Columbia
Canada	Regional Cancer Care at Thunder Bay Regional Health Sciences Centre	Thunder Bay	Ontario
Canada	Toronto Sunnybrook Regional Cancer Centre	Toronto	Ontario
Canada	British Columbia Cancer Agency	Vancouver	British Columbia
Canada	CancerCare Manitoba	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
NCIC Clinical Trials Group

Country where clinical trial is conducted

Canada, 

References & Publications (2)

Bjarnason GA, MacKenzie R, Hodson I, et al.: A randomized prospective phase-III study comparing the acute oral mucositis of morning vs. afternoon radiotherapy (RT) in patients (pts) with squamous cell carcinoma of the head and neck (SCCHN): NCIC-CTG HN.3.

Bjarnason GA, Mackenzie RG, Nabid A, Hodson ID, El-Sayed S, Grimard L, Brundage M, Wright J, Hay J, Ganguly P, Leong C, Wilson J, Jordan RC, Walker M, Tu D, Parulekar W; National Cancer Institute of Canada Clinical Trials Group (HN3). Comparison of toxici — View Citation