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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NCIC Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00004234
First received: January 28, 2000
Last updated: November 11, 2013
Last verified: March 2010
  Purpose

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.


Condition Intervention Phase
Head and Neck Cancer
Oral Complications
Procedure: management of therapy complications
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by NCIC Clinical Trials Group:

Study Start Date: August 1999
Study Completion Date: February 2009
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004234

Locations
Canada, British Columbia
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3
Fraser Valley Centre at Surrey Memorial Hospital
Surrey, British Columbia, Canada, V3V 1Z2
British Columbia Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Newfoundland and Labrador
Newfoundland Cancer Treatment and Research Foundation
St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Ontario
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6
Ottawa Regional Cancer Centre
Ottawa, Ontario, Canada, K1H 1C4
Regional Cancer Care at Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, Canada, P7B 6V4
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
CHUS-Hopital Fleurimont
Fleurimont, Quebec, Canada, J1H 5N4
McGill Cancer Centre
Montreal, Quebec, Canada, H2W 1S6
Centre Hospitalier Universitaire de Quebec
Quebec City, Quebec, Canada, G1R 2J6
Canada, Saskatchewan
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada, S7N 4H4
Sponsors and Collaborators
NCIC Clinical Trials Group
Investigators
Study Chair: Georg A. Bjarnason, MD, FRCPC Edmond Odette Cancer Centre at Sunnybrook
  More Information

Additional Information:
Publications:
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. [Abstract] J Clin Oncol 23 (Suppl 16): A-LBA5500, 500s, 2005 .

Responsible Party: NCIC Clinical Trials Group
ClinicalTrials.gov Identifier: NCT00004234     History of Changes
Other Study ID Numbers: HN3, CAN-NCIC-HN3, CDR0000067478
Study First Received: January 28, 2000
Last Updated: November 11, 2013
Health Authority: Canada: NCIC Clinical Trials Group

Keywords provided by NCIC Clinical Trials Group:
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

Additional relevant MeSH terms:
Head and Neck Neoplasms
Mouth Neoplasms
Stomatitis
Mucositis
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 17, 2014