Clinical trial · Interventional
Oral Mucositis in Patients Receiving Radiation Therapy for Cancer of the Mouth, Pharynx, or Larynx
A Comparison of Acute Oral Mucositis Between Morning and Afternoon Radiotherapy in Patients Receiving Radiation Treatment for Cancer of the Head and Neck
NCT00004234CI-TRIAL-00044500completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Oral Complications | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| management of therapy complications | Procedure | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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 therapyReferences
Publications (2)
- RESULTBjarnason 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 toxicity associated with early morning versus late afternoon radiotherapy in patients with head-and-neck cancer: a prospective randomized trial of the National Cancer Institute of Canada Clinical Trials Group (HN3). Int J Radiat Oncol Biol Phys. 2009 Jan 1;73(1):166-72. doi: 10.1016/j.ijrobp.2008.07.009. Epub 2008 Sep 19. PMID 18805649
- RESULTBjarnason 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 .