NCT01917942

Radiotherapy With Humidification in Head And Neck Cancer

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: Trans Tasman Radiation Oncology Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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

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

Conditions

• Cancer of the Head and Neck

Interventions

Type	Name	Description
DEVICE	Humidification	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.
OTHER	Standard of Care	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.

Timeline

• Start date: 2008-06-01
• Primary completion: 2011-11-01
• Completion: 2013-08-01
• First posted: 2013-08-07
• Last updated: 2017-07-12

Locations

1 site across 1 country: New Zealand