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Trial registered on ANZCTR


Registration number
ACTRN12616000725460
Ethics application status
Approved
Date submitted
30/05/2016
Date registered
1/06/2016
Date last updated
23/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Does Mepitel Film decrease skin reactions caused by radiation therapy in head and neck cancer patients?
Scientific title
Is Mepitel Film superior to a moisturing control cream in decreasing acute radiation-induced skin reactions in head and neck cancer patients?
Secondary ID [1] 289328 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute radiation-induced skin reactions 298929 0
Head and Neck Cancer 298930 0
Condition category
Condition code
Cancer 299006 299006 0 0
Head and neck
Skin 299007 299007 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mepitel Film is applied from day one of radiation therapy until the end of the trial (4 weeks after completion of radiation therapy) or until moist desquamation occurs. If moist desquamation occurs then these skin areas will be covered by the standard dressing that is used in each department.
The skin area of interest will be identified from the treatment plans and comprise of a skin area of at least 5 by 10 cm with a uniformly high dose (>30Gy). This area will be divided into two similar halves, one half will be randomized to Mepitel Film and the other to a moisturising control cream.

Mepitel Film will be applied by the researcher (a radiation therapist or radiation oncologist) and replaced only when necessary (when the film curls up too much).
Intervention code [1] 294883 0
Prevention
Intervention code [2] 294920 0
Treatment: Devices
Comparator / control treatment
The control cream is a common moisturising cream that does not contain sodium lauryl sulphate, for instance Sorbolene or Trolamine.

The control cream will be applied by the patients twice a day from the start of radiation treatment till the end of the trial (4 weeks after completion of radiation therapy) or until moist desquamation occurs. If moist desquamation occurs then these skin areas will be covered by the standard dressing that is used in each department.

The skin area of interest will be identified from the treatment plans and comprise of a skin area of at least 5 by 10 cm with a uniformly high dose (>30Gy). This area will be divided into two similar halves, one half will be randomized to Mepitel Film and the other to a moisturising control cream.
Control group
Active

Outcomes
Primary outcome [1] 298473 0
Skin reaction severity as determined by Radiation Induced Skin Reaction Assessment Scale (RISRAS) or Radiation Therapy Oncology Group (RTOG) score.
Timepoint [1] 298473 0
RISRAS and RTOG scores will be determined 3x a week from the moment of faint erythema till the end of radiation treatment and once a week for 4 weeks after completion of radiation therapy.
Secondary outcome [1] 324254 0
Time to development of moist desquamation. Moist desquamation is assessed by the research radiation therapist/oncologist 3x a week using RISRAS and RTOG grades.
Timepoint [1] 324254 0
The number of days after the start of radiation therapy until moist desquamation develops.
Moist desquamation is assessed by the research radiation therapist/oncologist 3x a week using RISRAS and RTOG grades.
Secondary outcome [2] 324255 0
Time to healing of moist desquamation. Moist desquamation is assessed by the research radiation therapist/oncologist 3x a week using RISRAS and RTOG grades.
Timepoint [2] 324255 0
Number of days that moist desquamation is present. Moist desquamation is assessed by the research radiation therapist/oncologist 3x a week using RISRAS and RTOG grades.

Eligibility
Key inclusion criteria
Patients receiving radiation and chemoradiation for squamous cell carcinoma of the oropharynx, nasopharynx and oral cavity.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Radiation or chemoradiation <30Gy
Distant metastatic disease
Previous radiation to the head and neck area
Skin consitions that may aggrevate radiation-induced skin reactions
Karnofski score<70%
Patients with facial hair on the treatment site

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Based on the RT plan, an area of high dose (>30Gy) of at least 5 by 10 cm will be selected and divided into 2 equal halves. One half will be randomized to Mepitel Film, the other to control cream.

Randomization of which half will be covered in Mepitel Film and which half in control cream is done centrally based on computer-generated random numbers, provided by a biostatistician at the University of Otago, Wellington. The research radiation therapist/radiation oncologist sends a randomization request to the PI, Dr Herst who will allocate the superior/lateral or the inferior/medial to either film of cream based on the computer-generated numbers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random numbers produced by the University's biostatistician, Dr Dalice Sim
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Participants will act as their own controls. The treatment plan will be used to identify a skin area of at least 5 by 10 cm that has the highest uniform skin dose. This area will be divided into two equal parts. One part will be randomly assigned to the Mepitel Film arm and the other half will be treated with control cream. Randomization will be based on computer generated random numbers. The trial cannot be blinded because of the obvious differences between film and cream.
Phase
Phase 2 / Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Based on preliminary analysis of our current pilot study, in order to see a difference of 30% in total RISRAS score (or 15% in researcher component of RISRAS) and power the trial to 90% and p value of 0.05 to see a difference of 30% in total RISRAS score (or 15% in researcher component of RISRAS), we need 72 patients, with attrition of 20% that would be 86 patients.

The statistical significance between differences in Mepitel Film and control cream RISRAS scores will be determined by non-parametric Wilcoxon signed ranks test, as previous trials have shown that the scores are not all normally distributed. Averages, standard deviations and unpaired two tailed student T tests will be used to determine dose measurements.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
After the feasibility study in NZ and China was completed (n=36), recruitment continued in Nanjing with another 32 patients enrolled (total 68) using the exact same protocol. Based on publication of the feasibility study. the hospital in Nanjing started providing the intervention, Mepitel Film, to patients at a reduced price in April 2018. No more patients were recruited after that time.
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7923 0
New Zealand
State/province [1] 7923 0
Christchurch
Country [2] 7924 0
China
State/province [2] 7924 0
Nanjing

Funding & Sponsors
Funding source category [1] 293700 0
University
Name [1] 293700 0
University of Otago
Address [1] 293700 0
PO Box 56
Dunedin, 9054
New Zealand
Country [1] 293700 0
New Zealand
Funding source category [2] 293701 0
Hospital
Name [2] 293701 0
Christchurch Hospital
Address [2] 293701 0
2 Riccarton Avenue
Christchurch 8140
Country [2] 293701 0
New Zealand
Funding source category [3] 293702 0
Hospital
Name [3] 293702 0
Drum Tower Hospital
Address [3] 293702 0
321 Zhongshan Road
Gulou (Drum Tower) District
Nanjing, Jiangsu 210008
Country [3] 293702 0
China
Funding source category [4] 293724 0
Commercial sector/Industry
Name [4] 293724 0
Molnlycke Healtcare LTD
Address [4] 293724 0
Box 130 80
Gamlestadsvägen 3C
SE-402 52 Gothenburg
Country [4] 293724 0
Sweden
Primary sponsor type
University
Name
Otago University
Address
PO Box 56
Dunedin, 9054
New Zealand
Country
New Zealand
Secondary sponsor category [1] 292556 0
None
Name [1] 292556 0
Address [1] 292556 0
Country [1] 292556 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295139 0
Drum Tower Hospital Ethics Committee
Ethics committee address [1] 295139 0
321 Zhongshan Road
Gulou (Drum Tower) District
Nanjing, Jiangsu 210008
Ethics committee country [1] 295139 0
China
Date submitted for ethics approval [1] 295139 0
31/12/2015
Approval date [1] 295139 0
25/03/2016
Ethics approval number [1] 295139 0
protocol number 2016-019-12

Summary
Brief summary
External beam irradiation is a common treatment option for most solid cancers. Although the skin of all patients receives a certain amount of radiation, the skin dose in patients with tumours close to the skin, such as 40-60% of breast and head and neck cancer patients is high enough to cause severe reactions. Severe skin reactions can be very painful and affect patient quality of life as well as increasing the chance of developing infections.

Our previous three skin trials in breast cancer patients in New Zealand showed that soft silicone dressings decreased skin reaction severity (1–4). The skin dose received by breast cancer patients was less than 40Gy. However, a small pilot study in NZ head and neck cancer patients receiving a higher skin dose (>45Gy) suggested that Mepitel Film was less effective.

The aim of this trial is to determine in a larger cohort how effective Mepitel Film is in preventing and managing acute skin reactions caused by radiation therapy to cancer in the head and neck region. We used the preliminary results from the head and neck pilot study to recruit enough patients to be able to see a statistically significant decrease of 30% in skin reaction severity as measured by RISRAS trial.

References
1. Diggelmann K, Zytkovicz A, Tuaine J, Bennett N, Kelly L, Herst P. Brit J Radiol [Internet]. 2010 Nov [cited 2012 May 9];83(995):971–8.
2. Paterson D, Poonam P, Bennett N, Peszynski R, Van Beekhuizen M, Jasperse M, et al. J Cancer Sci Ther [Internet]. 2012 [cited 2013 Jul 3];04(11):347–56.
3. Herst P, Bennet N, Sutherland A, Peszynski R, Paterson D, Jasperse M. Radiother Oncol., 2014 Jan;110(1):137-43. doi: 10.1016/j.radonc.2014.01.005.
4. Herst P. J Med Radiat Sci [Internet]. 2014 Jun 28 [cited 2014 Jul 4];61(2):119–25.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2905 2905 0 0

Contacts
Principal investigator
Name 66266 0
A/Prof Patries Herst
Address 66266 0
Department of Radiation Therapy University of Otago, Wellington POBox 7343 Wellington South 6242
Country 66266 0
New Zealand
Phone 66266 0
+64-4-3855475
Fax 66266 0
+64-4-3855375
Email 66266 0
patries.herst@otago.ac.nz
Contact person for public queries
Name 66267 0
A/Prof Patries Herst
Address 66267 0
Department of Radiation Therapy University of Otago, Wellington POBox 7343 Wellington South 6242
Country 66267 0
New Zealand
Phone 66267 0
+64-4-3855475
Fax 66267 0
+64-4-3855375
Email 66267 0
patries.herst@otago.ac.nz
Contact person for scientific queries
Name 66268 0
A/Prof Patries Herst
Address 66268 0
Department of Radiation Therapy University of Otago, Wellington POBox 7343 Wellington South 6242
Country 66268 0
New Zealand
Phone 66268 0
+64-4-3855475
Fax 66268 0
+64-4-3855375
Email 66268 0
patries.herst@otago.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary