Radiotherapy With Humidification in Head And Neck Cancer (RadioHum)

Trans Tasman Radiation Oncology Group

Status and phase

Completed

Phase 3

Conditions

Cancer of the Head and Neck

Treatments

Other: Standard of Care

Device: Humidification

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01917942

TROG 07.03

Details and patient eligibility

About

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.

Full 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

Enrollment

210 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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