Radiotherapy With Humidification in Head and Neck Cancer (RadioHum)

• Intensity of mucositis as a function of time for CTCAE grade > 1 mucositis measured as the area under the time curve IAUc) of the plot expressing grade of acute reactions vs weeks for observed CTCAE mucosal reactions > 1 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  

• Mucositis grades, Pain on swallowing, Days narcotic use, Nutritional support data, Nutritional mode, Mean nutritional mode, Hospitalisations, RT dose / duration / prescribed, Loco-regional control, Quality of life data, Survival. [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
  

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.