Status:
COMPLETED
Radiotherapy With Humidification in Head And Neck Cancer
Lead Sponsor:
Trans Tasman Radiation Oncology Group
Collaborating Sponsors:
Auckland City Hospital
Fisher and Paykel Healthcare
Conditions:
Cancer of the Head and Neck
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a two arm randomised phase III trial which will evaluate prospectively the benefits of humidification in patients receiving radiotherapy / chemoradiation for head and neck cancer. The intent o...
Detailed Description
This phase III trial will address four hypotheses. The primary hypothesis is: Humidification will modulate the natural history of mucositis resulting in a clinically significant reduction in the inte...
Eligibility Criteria
Inclusion
- Patients who meet the following criteria will be eligible:
- Pathologically confirmed diagnosis of cancer involving the Nasopharynx, Oropharynx, Oral Cavity, Larynx, or Hypopharynx
- Regional nodal irradiation included in PTV1 (as a minimum ipsilateral levels II-III)
- Prescribed dose of radiotherapy is at least 60 Gy
- Receiving definitive or post-operative adjuvant Radiotherapy
- Receiving Radiotherapy as sole modality or Chemoradiation
- Patient \> 18 years old
- Available for follow-up for up to 2 years
- Life expectancy greater than 6 months
- Written informed consent
- Participation of patients on other clinical trial protocols permitted
Exclusion
- Patients who meet the following criteria will be excluded:
- Presence of tracheostomy or stoma
- Diagnosis of T1 / T2 glottic carcinoma
- Undergoing CPAP therapy -Treatment with Amifostine or Palifermin (keratinocyte growth factor) during radiotherapy
- History of previous radiotherapy to the head and neck region, excluding superficial radiotherapy to cutaneous squamous cell carcinoma or basal cell carcinoma
- High risk for poor compliance with radiotherapy, humidification, or follow-up as assessed by the investigator
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2013
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT01917942
Start Date
June 1 2008
End Date
August 1 2013
Last Update
July 12 2017
Active Locations (1)
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1
Auckland Hospital
Auckland, New Zealand, 1001