Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001326280
Ethics application status
Approved
Date submitted
4/08/2018
Date registered
7/08/2018
Date last updated
18/03/2022
Date data sharing statement initially provided
19/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the efficacy of continuous positive airway pressure (CPAP) in patients receiving radiotherapy treatment for centrally located lung cancer.
Scientific title
Investigating the efficacy of continuous positive airway pressure (CPAP) in patients receiving radiotherapy treatment for centrally located lung cancers.
Secondary ID [1] 295725 0
Nil known
Universal Trial Number (UTN)
U1111-1208-2595
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Cancer 309121 0
Condition category
Condition code
Cancer 307997 307997 0 0
Lung - Small cell
Cancer 307998 307998 0 0
Lung - Non small cell
Cancer 308023 308023 0 0
Lung - Mesothelioma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study participants will undergo Computed Tomography (CT) imaging as per standard clinical protocol. Approximately 10minutes later that participant will undergo CT imaging while attached to continuous positive airway pressure therapy (CPAP). The participant may also have Radiotherapy treatment delivered while attached to CPAP.

Prior to imaging, the participant will have a CPAP face-mask fitted and a tolerable pressure for the participant in the range of 10-20cm H20 will be determined. This will occur at the hospital under the instruction of Respiratory Technicians. The participant will then have CT images acquired without CPAP as per standard clinical protocol. The participant will remain in the CT while staff attach CPAP. Approximately 10 minutes later the participant will then have CT images acquired with CPAP. This will be performed in the Radiation Oncology department of the hospital and performed by Radiation Therapists. If CPAP improves the quality of Radiotherapy treatment for the individual participant, the participant will also use CPAP during their Radiotherapy treatment delivery, with each delivery taking approximately half an hour.

Participants will be asked to complete a short questionnaire after the CT imaging and first, middle, and last day of Radiotherapy treatment (if CPAP is used during Radiotherapy treatment) to indicate their comfort and tolerability of using CPAP during CT and Radiotherapy.
Intervention code [1] 302049 0
Treatment: Devices
Comparator / control treatment
This is a pilot study where the participant is their own control. Each participant will undergo CT imaging without CPAP (current standard clinical protocol) and with CPAP. Two Radiotherapy treatments will then be planned for the participant; one where they do not use CPAP during Radiotherapy treatment (current standard clinical protocol) and one where they do use CPAP during Radiotherapy treatment. The quality of the two Radiotherapy treatment plans for the individual participant will be compared by the Radiation Oncologist and Physicist and the best treatment plan will be selected for treatment delivery.
Control group
Active

Outcomes
Primary outcome [1] 307018 0
Geometrical displacement of the lung tumour to surrounding organs at risk (OARs), measured by the displacement distance (mm).
Timepoint [1] 307018 0
After Radiotherapy treatment planning, approximately 2-4 weeks after CT imaging.
Primary outcome [2] 307019 0
Tumour motion, as assessed by largest tumour motion displacement (mm) throughout the respiratory cycle in three anatomical planes (transverse, sagittal, coronal).
Timepoint [2] 307019 0
After Radiotherapy treatment planning, approximately 2-4 weeks after CT imaging.
Primary outcome [3] 307020 0
Quality of Radiotherapy treatment plan, assessed by current clinical departmental dosimetric parameters to the tumour and surrounding organs at risk eg. mean dose, V5, V90, D99, D90.
Timepoint [3] 307020 0
After Radiotherapy treatment planning, approximately 2-4 weeks after CT imaging.
Secondary outcome [1] 350353 0
Patient tolerability of using CPAP during CT imaging, assessed by a study-specific questionnaire given to all study participants that asks about discomfort, symptoms, and patient experience.
Timepoint [1] 350353 0
Immediately after CT imaging.
Secondary outcome [2] 350354 0
Patient tolerability of using CPAP during Radiotherapy treatment, assessed in participants that use CPAP during Radiotherapy treatment by a study-specific questionnaire that assesses discomfort, symptoms, and patient experience.
Timepoint [2] 350354 0
First, middle, and last Radiotherapy treatment delivery; approximately 6 weeks, 6.5-7weeks, and 7-8 weeks after CT imaging respectively.

Eligibility
Key inclusion criteria
Patients who meet the following criteria will be eligible:
-Aged 16 years or older.
- Diagnosed with centrally located lung tumour, defined as within 2cm in all directions of any mediastinal critical structure, including the bronchial tree, esophagus, heart, brachial plexus, major vessels, spinal cord, phrenic nerve and recurrent laryngeal nerve.
- Prescribed (by an Radiation Oncology) a Radiotherapy Treatment of 60Gy in 8 fractions (SABR) or 48Gy in 12 fractions (hypofractionation).
- Meets the current departmental inclusion criteria for a treatment prescription of 60Gy in 8 fractions (SABR) or 48Gy in 12 fractions (hypofractionation).
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients that have significant comorbidities that may result in them not tolerating treatment with CPAP (recent surgery, respiratory conditions, inappropriate age, and disabilities).
Patients who are unable to provide informed consent or who refuse to use CPAP.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analysis shall be conducted using a per protocol analysis.

Change in the magnitude of tumour motion with and without CPAP will be calculated by subtracting the vector of the greatest dimension of the Gross Tumour Volume from the Internal Target Volume in the super-inferior, right-left, and anterior-posterior planes. The relative impact of CPAP on target motion comopared to without CPAP will be expressed as percentage. The statistical significance of the change in tumour motion will be assessed with the Wilcoxon signed-rank test.

Change in organ displacement from the tumour will be quantified in millimeters. The statistical significance of displacement change with and without CPAP will be assessed with Wilcoxon signed-rank test.

Dosimetric comparisons between the Radiotherapy treatment plan without CPAP and with CPAP will be compared. This will include mean doses to all surrounding structures, doses to specified volumes of lung and heart, and target volume dose coverage. The statistical significance will be assessed with the Wilcoxon signed-rank test.

The general tolerance of CPAP by the patients will be analysed by determining the mean level of discomfort experienced by all participants in specific areas, creating a list of symptoms/unease that patients experienced, and by quantifying how the level of tolerance/discomfort with CPAP changed throughout treatment compared to baseline values given after the CT. The compliance will also be assessed by the number of participants that request to no longer use CPAP for their treatments.


Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/08/2018
Actual
10/08/2018
Date of last participant enrolment
Anticipated
1/12/2022
Actual
Date of last data collection
Anticipated
31/12/2022
Actual
Sample size
Target
20
Accrual to date
14
Final
Recruitment outside Australia
Country [1] 20729 0
New Zealand
State/province [1] 20729 0

Funding & Sponsors
Funding source category [1] 300316 0
Hospital
Name [1] 300316 0
Auckland City Hospital
Country [1] 300316 0
New Zealand
Primary sponsor type
Hospital
Name
Auckland City Hospital
Address
2 Park Rd, Grafton, Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 299771 0
None
Name [1] 299771 0
Address [1] 299771 0
Country [1] 299771 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301127 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 301127 0
133 Molesworth Street,
Thorndon,
Wellington 6011
Ethics committee country [1] 301127 0
New Zealand
Date submitted for ethics approval [1] 301127 0
08/02/2018
Approval date [1] 301127 0
29/05/2018
Ethics approval number [1] 301127 0
18/NTA/24

Summary
Brief summary
This is a pilot study investigating whether CPAP improves the quality of Radiotherapy treatment for centralised lung cancers. Respiratory motion is an obstacle in radiotherapy treatments, especially when delivering high radiation doses to lung tumours in stereotactic ablative radiotherapy (SABR) or hypofractionated radiotherapy treatments. It is well known that a reduction in respiratory motion during radiotherapy treatment improves the accuracy of radiation delivery to the tumour and reduces the amount of radiation delivered to surrounding healthy tissues. CPAP is a device that applies positive air pressure to the airways. Recent publications have investigated the use of CPAP for motion management in Lung Radiotherapy treatments with encouraging results. It is suggested that CPAP reduces tumour motion, making it an easier radiotherapy target, and additionally displaces healthy surrounding structures away from the tumour and radiation field, allowing more healthy tissue to be spared.

No study has specifically investigated how CPAP effects the quality of radiotherapy treatments for centralised lung tumours and how CPAP alters the geometric displacement of surrounding structures to centrally located lung tumours. If surrounding critical structures can be further displaced from the tumour by using CPAP, then potentially a higher prescription dose or more optimal treatment delivery regime may be achievable. Data from this study will inform a future larger clinical trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85950 0
Dr Louis Lao
Address 85950 0
Auckland City Hospital,
Cancer & Blood, Radiation Therapy,
Level 4 Building 8,
2 Park Road,
Grafton, Auckland, 1023
Country 85950 0
New Zealand
Phone 85950 0
6421830645
Fax 85950 0
Email 85950 0
LLao@adhb.govt.nz
Contact person for public queries
Name 85951 0
Ms Suzanne Lydiard
Address 85951 0
Auckland City Hospital,
Cancer & Blood, Radiation Therapy,
Level 4 Building 8,
2 Park Road,
Grafton, Auckland, 1023
Country 85951 0
New Zealand
Phone 85951 0
+649 367 0000 ext 22885 or +6421750696
Fax 85951 0
Email 85951 0
slyd6788@uni.sydney.edu.au
Contact person for scientific queries
Name 85952 0
Ms Suzanne Lydiard
Address 85952 0
Auckland City Hospital,
Cancer & Blood, Radiation Therapy,
Level 4 Building 8,
2 Park Road,
Grafton, Auckland, 1023
Country 85952 0
New Zealand
Phone 85952 0
+64 21750696
Fax 85952 0
Email 85952 0
slyd6788@uni.sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.