Radiotherapy With Humidification in Head And Neck Cancer (RadioHum)
July 10, 2017 updated by: Trans Tasman Radiation Oncology Group
A Randomised Phase III Trial of Radiotherapy With Humidification in Head And Neck Cancer
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 of humidification is to moisturise the mucosa.
The rationale for the use of humidification with radiotherapy can be considered an extension of the general principle of moist wound care in wound management.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 intensity of severe acute mucositis as a function of time for CTCAE grade > 1 mucositis (e.g. grade 2 or higher), measured as the area under the time curve (AUC) of the plot expressing grade of acute reactions vs weeks for observed CTCAE mucosal reactions > 1
The additional hypotheses are:
- Humidification will palliate the acute symptoms of mucositis and xerostomia
- Humidification is cost effective through a reduction in hospital bed occupancy
- Humidification will improve the functional outcome, particularly swallowing function, of patients with head and neck cancer treated with radiotherapy
Study Type
Interventional
Enrollment (Anticipated)
210
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Auckland, New Zealand, 1001
- Auckland Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
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 Criteria:
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Standard of Care
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SOC: institutional standard of care for the management of mucositis.
SOC will be defined by each participating institution and be kept consistent at that institution for the duration of the study.
In general, SOC will consist of rinsing with 50:50 salt bicarbonate of soda mouthwash; benzydamine mouthwash; appropriate analgesic, antimicrobial and antifungal protocols etc.
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Experimental: Humidification
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Fisher and Paykel Healthcare MR880 humidifier + HC211 flow source.
37/44 Humidification (37oC at 100% relative humidity, 44 mg of water per litre of air, 25 litres per min initial flow rate).
The patients will be instructed to use humidification from day 1 of the radiotherapy course as much as is practical; the preference is for continuous overnight humidification plus maximal use throughout the day.Humidification will continue throughout treatment until at least week 8 after the commencement of radiotherapy and will cease when the CTCAE mucositis (clinical exam) score becomes less than grade 2, or at the week 16 assessment, whichever is earliest.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Intensity of mucositis as a function of time for CTCAE grade > 1 mucositis (e.g. grade 2 or higher) measured as the area under the time curve (AUC) of the plot expressing grade of acute reactions vs weeks for observed CTCAE mucosal reactions > 1.
Time Frame: week 12
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week 12
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Andrew Macann, Auckland Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2008
Primary Completion (Actual)
November 1, 2011
Study Completion (Actual)
August 1, 2013
Study Registration Dates
First Submitted
August 1, 2013
First Submitted That Met QC Criteria
August 5, 2013
First Posted (Estimate)
August 7, 2013
Study Record Updates
Last Update Posted (Actual)
July 12, 2017
Last Update Submitted That Met QC Criteria
July 10, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TROG 07.03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.