Cancer of the Head and NeckPhase 3RadioHumNCT01917942
Radiotherapy With Humidification in Head And Neck Cancer
A Phase 3 study testing Humidification in people with Cancer of the Head and Neck, run by Trans Tasman Radiation Oncology Group at 1 site in New Zealand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of the Head and Neck
- What is being tested?
- Humidification
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteNew Zealand
- Study dates
- Jun 2008to Aug 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Phase III Trial of 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.
Read the 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
- Conditions
- Cancer of the Head and Neck
- Being tested
- Humidification, Standard of Care
- Keywords
- Radiotherapy, Humidification, Mucositis
- Medical subject headings
- Head and Neck Neoplasms, Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HumidificationDevice
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 CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Standard of Care Receives: Other: Standard of Care |
| Humidification | Experimental | Humidification Receives: Device: Humidification |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2013 (estimated)
- Study startJun 2008
- Primary completionNov 2011
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of the Head and NeckStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trans Tasman Radiation Oncology Group
- Sponsor type
- University, hospital or other
- Collaborators
- Auckland City Hospital, Fisher and Paykel Healthcare
- Responsible party
- Sponsor
- Investigators
- Andrew Macann, Study chair, Auckland Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01917942
- Sponsor's protocol ID
- TROG 07.03
- Acronym
- RadioHum
- Status last verified
- Jul 2017
- First submitted
- 1 Aug 2013
- Last updated
- 12 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Phase III Trial of Radiotherapy With Humidification in Head And Neck Cancer
- ClinicalTrials.gov ID
- NCT01917942
- Acronym / sponsor ID
- RadioHum / TROG 07.03
- Conditions
- Cancer of the Head and Neck
- Keywords
- Radiotherapy, Humidification, Mucositis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Trans Tasman Radiation Oncology GroupUniversity, hospital or other
- Collaborators
- Auckland City Hospital, Fisher and Paykel Healthcare
- Study start
- Jun 2008
- Primary completion
- Nov 2011 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 7 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Other: Standard of CareStandard of Care |
| Humidification | Experimental | Device: HumidificationHumidification |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HumidificationFisher 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. | Device | Humidification |
| Standard of CareSOC: 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. | Other | Standard of Care |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2017.
- Click here for more information about this study on the TROG official websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Macann study chair
Auckland Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Humidification in people with Cancer of the Head and Neck, run by Trans Tasman Radiation Oncology Group at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2017.