Radiotherapy With Humidification in Head And Neck Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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A Randomised Phase III Trial of Radiotherapy With Humidification in Head And Neck Cancer

Conditions
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Cancer of the Head and Neck

Intervention / Treatment
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* Device: Humidification
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care<br>Standard of Care | Other: Standard of Care<br>* 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.<br>|
| Experimental: Humidification<br>Humidification | Device: Humidification<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiotherapy, Humidification, Mucositis