Radiotherapy With Humidification in Head And Neck Cancer — RadioHum  

Cancer of the Head and Neck Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Cancer of the Head and Neck
• Head and Neck Neoplasms

• NCT number: NCT01917942
• Study type: Interventional
• Source: Trans-Tasman Radiation Oncology Group (TROG)
• Status: Completed
• Phase: Phase 3
• Start date: June 2008
• Completion date: August 2013