Trial Information

Radiotherapy With Humidification in Head and Neck Cancer: A Randomised Phase III Trial of the Trans Tasman Radiation Oncology Group in Collaboration With Fisher and Paykel Healthcare

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
in which the target volume encompasses a significant volume of the pharynx +/- oral cavity.
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.

At 37 degrees C at 100% relative humidity, there are 44 mg of water per litre of gas (37/44
humidification) which is the humidification level which will be used in the trial. The
Fisher and Paykel Healthcare MR880 humidifier, in conjunction with the HC211 / HC232 flow
source, heats the gas (air) and water to the appropriate temperature and uses a heated
insulated tube to deliver water vapour via a nasal interface. There is continuous feedback
adjustment from sensors to optimise the humidification delivery and prevent rainout
(condensation within the tube and at the interface). Patients will commence humidification
at a flow rate of 25 litres / min. Domiciliary based humidification using this humidifier
for prolonged periods in head and neck cancer patients receiving radiotherapy has been
demonstrated to be feasible with high levels of patient compliance.

The control arm will receive the institutional standard of care (SOC) for the management of
mucositis: 50:50 salt bicarbonate of soda mouthwash; benzydamine mouthwash; appropriate
analgesic, antimicrobial and antifungal protocols etc.

The experimental arm will receive SOC + 37/44 humidification. 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. This will be domiciliary based. Humidification will continue throughout
treatment until at least week 8 after the commencement of radiotherapy and will cease when
the CTCAE v3.0 mucositis (clinical exam) score becomes less than grade 2, or at the week 16
review, whichever is earliest.

The control arm is not permitted to use a humidifier at any stage from baseline through to
week 20.

The principal objective is to evaluate the impact of humidification on the acute toxicities
experienced by patients treated with radiotherapy for head and neck cancer. The primary
endpoint is the 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.
Secondary objectives will include evaluating the feasibility and compliance of domiciliary
humidification with radiotherapy in head and neck cancer; the effect of humidification on
the patient's experience of acute treatment toxicities; the effect of humidification on
hospitalisation rates and hospital bed occupancy; and the effect of humidification on long
term swallowing function in patients treated with radiotherapy for head and neck cancer.