Radiotherapy With Humidification in Head And Neck Cancer (RadioHum)
Primary Purpose
Cancer of the Head and Neck
Status
Completed
Phase
Phase 3
Locations
New Zealand
Study Type
Interventional
Intervention
Humidification
Standard of Care
Sponsored by
About this trial
This is an interventional supportive care trial for Cancer of the Head and Neck focused on measuring Radiotherapy, Humidification, Mucositis
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
Sites / Locations
- Auckland Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard of Care
Humidification
Arm Description
Standard of Care
Humidification
Outcomes
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01917942
First Posted
August 1, 2013
Last Updated
July 10, 2017
Sponsor
Trans Tasman Radiation Oncology Group
Collaborators
Auckland City Hospital, Fisher and Paykel Healthcare
1. Study Identification
Unique Protocol Identification Number
NCT01917942
Brief Title
Radiotherapy With Humidification in Head And Neck Cancer
Acronym
RadioHum
Official Title
A Randomised Phase III Trial of Radiotherapy With Humidification in Head And Neck Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Trans Tasman Radiation Oncology Group
Collaborators
Auckland City Hospital, Fisher and Paykel Healthcare
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of the Head and Neck
Keywords
Radiotherapy, Humidification, Mucositis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
210 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Standard of Care
Arm Title
Humidification
Arm Type
Experimental
Arm Description
Humidification
Intervention Type
Device
Intervention Name(s)
Humidification
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
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 Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Macann
Organizational Affiliation
Auckland Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Auckland Hospital
City
Auckland
ZIP/Postal Code
1001
Country
New Zealand
12. IPD Sharing Statement
Links:
URL
http://www.trog.com.au
Description
Click here for more information about this study on the TROG official website
Learn more about this trial
Radiotherapy With Humidification in Head And Neck Cancer
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