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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01917942




Registration number
NCT01917942
Ethics application status
Date submitted
1/08/2013
Date registered
7/08/2013
Date last updated
12/07/2017

Titles & IDs
Public title
Radiotherapy With Humidification in Head And Neck Cancer
Scientific title
A Randomised Phase III Trial of Radiotherapy With Humidification in Head And Neck Cancer
Secondary ID [1] 0 0
TROG 07.03
Universal Trial Number (UTN)
Trial acronym
RadioHum
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer of the Head and Neck 0 0
Condition category
Condition code
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Humidification
Other interventions - Standard of Care

Active comparator: Standard of Care - Standard of Care

Experimental: Humidification - Humidification


Treatment: Devices: 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.

Other interventions: 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.
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
week 12

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2013
Sample size
Target
210
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
Trans Tasman Radiation Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Auckland City Hospital
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Fisher and Paykel Healthcare
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01917942
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew Macann
Address 0 0
Auckland Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01917942