Clinical trial NCT01917942: Radiotherapy With Humidification in Head And Neck Cancer
Official title: A Randomised Phase III Trial of Radiotherapy With Humidification in Head And Neck Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cancer of the Head and Neck
Keywords: Radiotherapy
Humidification
Mucositis
Lead sponsor: Trans Tasman Radiation Oncology Group
Sponsor class: OTHER
Collaborators: name: Auckland City Hospital
name: Fisher and Paykel Healthcare
First posted: 2013-08-07
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: Auckland Hospital
Study officials:
affiliation: Auckland Hospital
name: Andrew Macann
role: STUDY_CHAIR
References: