Skip to main content
OpenTrials
Completed

NCT Number: NCT01917942

Radiotherapy With Humidification in Head And Neck Cancer

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cancer of the Head and Neck Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Head and Neck Neoplasms Mouth Diseases Mucositis Neoplasms Neoplasms by Site Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Auckland Hospital

Auckland, 1001, New Zealand

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Humidification

Device

Fisher and Paykel Healthcare MR880 humidifier + HC211 flow source. 37/44 Humidification (37oC at 100% relative humidity, 44 mg of water per litre of air, 25 litres per min initial flow rate). 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.Humidification will continue throughout treatment until at least week 8 after the commencement of radiotherapy and will cease when the CTCAE mucositis (clinical exam) score becomes less than grade 2, or at the week 16 assessment, whichever is earliest.

Standard of care

Other

SOC: institutional standard of care for the management of mucositis. SOC will be defined by each participating institution and be kept consistent at that institution for the duration of the study. In general, SOC will consist of rinsing with 50:50 salt bicarbonate of soda mouthwash; benzydamine mouthwash; appropriate analgesic, antimicrobial and antifungal protocols etc.

Primary outcomes

  1. 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.

    Time frame: week 12

Sponsors and collaborators

Lead sponsor

Trans Tasman Radiation Oncology Group

Other

Collaborators

  • Auckland City Hospital
  • Fisher and Paykel Healthcare

Registry information

Official study title

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

Acronym: RadioHum

Important dates

Study start
2008
Primary completion
2011
Study completion
2013
First posted
Aug 7, 2013
Registry last updated
Jul 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.