Radiotherapy With Humidification in Head And Neck Cancer (RadioHum)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Auckland City Hospital, New Zealand
Fisher and Paykel Healthcare
Information provided by (Responsible Party):
Trans-Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov Identifier:
NCT01917942
First received: August 1, 2013
Last updated: August 5, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Cancer of the Head and Neck
Device: Humidification
Other: Standard of Care
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Randomised Phase III Trial of Radiotherapy With Humidification in Head And Neck Cancer

Resource links provided by NLM:


Further study details as provided by Trans-Tasman Radiation Oncology Group (TROG):

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 210
Study Start Date: June 2008
Estimated Study Completion Date: August 2013
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard of Care
Standard of Care
Other: Standard of Care
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.
Experimental: Humidification
Humidification
Device: Humidification
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01917942

Locations
New Zealand
Auckland Hospital
Auckland, New Zealand, 1001
Sponsors and Collaborators
Trans-Tasman Radiation Oncology Group (TROG)
Auckland City Hospital, New Zealand
Fisher and Paykel Healthcare
Investigators
Study Chair: Andrew Macann Auckland Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Trans-Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov Identifier: NCT01917942     History of Changes
Obsolete Identifiers: NCT00598520
Other Study ID Numbers: TROG 07.03
Study First Received: August 1, 2013
Last Updated: August 5, 2013
Health Authority: New Zealand: Health and Disability Ethics Committees
Australia: Human Research Ethics Committee

Keywords provided by Trans-Tasman Radiation Oncology Group (TROG):
Radiotherapy
Humidification
Mucositis

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on April 17, 2014