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Trial registered on ANZCTR


Registration number
ACTRN12614000932662
Ethics application status
Approved
Date submitted
26/08/2014
Date registered
1/09/2014
Date last updated
3/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of Mepitel Film on skin reaction severity and moist desquamation rates in patients undergoing radiation therapy for head and neck cancer: a pilot study
Scientific title
The effect of Mepitel Film compared with sorbolene cream on acute radiation-induced skin reaction severity and moist desquamation rates in patients undergoing radiation therapy for head and neck cancer: a randomized intra-patient controlled pilot study
Secondary ID [1] 285232 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 292862 0
Cancer of the Head and Neck region 292897 0
Condition category
Condition code
Cancer 293160 293160 0 0
Head and neck
Skin 293161 293161 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We changed the intervention from a management. to a prophylactic trial. The film is now applied from day one of radiation therapy until the end of the trial or until moist desquamation occurs. If moist desquamation occurs then these patches 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 cm2 with a uniform high dose (>40Gy). Thi sarea will be divided into two similar halves, one half will be randomized to film and the other to cream.


Intervention code [1] 290107 0
Treatment: Devices
Intervention code [2] 290135 0
Prevention
Comparator / control treatment
Sorbolene will be applied twice a day from day one of radiation therapyuntil the end of the trial or until moist desquamation occurs. If moist desquamation occurs then these patches will be covered by the standard dressing that is used in each department.
Control group
Active

Outcomes
Primary outcome [1] 293017 0
Skin reaction severity as determined by Radiation Induced Skin Reaction Assessment Scale (RISRAS) or Radiation Therapy Oncology Group (RTOG) score.
Timepoint [1] 293017 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] 310158 0
Percentage of patients who develop moist desquamation either in the control area and/or in the treatment area and the time it takes for moist desquamation to develop.
Timepoint [1] 310158 0
Time to development of moist desquamation.
Secondary outcome [2] 310159 0
Effect of psychosocial stress on skin reaction severity as determined by validated Distress Thermometer.
Timepoint [2] 310159 0
This measures will be used at baseline and weekly after that.
Secondary outcome [3] 310253 0
Time to healing of moist desquamation
Timepoint [3] 310253 0
Number of days it takes for the moist desquamation to heal

Eligibility
Key inclusion criteria
patients receiving radiation and chemoradiation
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)
Protocol has changed from a management to a preventative trial. 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 sorbolene cream.

Randomization of which half will be covered in film and which half in cream is done centrally based on computer-generated random numbers, provided by a biostatistician at the University of Otago, Wellington. The research radiation therapist 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 James Stanley
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 >5cm2 that has the highest 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 sorbolene 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
Type of endpoint(s)
Efficacy
Statistical methods / analysis
This is a pilot study to determine the percentage of moist desquamation in the skin treated with sorbolene cream and that treated with Mepitel Film. Based on the results of this study we will be able to determine the number of participants needed to power a larger international study to 80% with an alpha of 0.05.

Recruitment
Recruitment status
Completed
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] 6310 0
New Zealand
State/province [1] 6310 0
Christchurch
Country [2] 7374 0
China
State/province [2] 7374 0

Funding & Sponsors
Funding source category [1] 289842 0
University
Name [1] 289842 0
University of Otago
Address [1] 289842 0
23A Mein Street
PO BOX 7343
Wellington South
Wellington 6242
Country [1] 289842 0
New Zealand
Funding source category [2] 289843 0
Hospital
Name [2] 289843 0
Christchurch Hospital
Address [2] 289843 0
Private Bag 4710
Christchurch 8140
Country [2] 289843 0
New Zealand
Funding source category [3] 289845 0
Hospital
Name [3] 289845 0
Dunedin Hospital
Address [3] 289845 0
Private Bag 1921

Dunedin 9054
Country [3] 289845 0
New Zealand
Funding source category [4] 289847 0
Commercial sector/Industry
Name [4] 289847 0
Molnlycke Healthcare
Address [4] 289847 0
Box 130 80
Gamlestadsvägen 3C
SE-402 52 Gothenburg
Country [4] 289847 0
Sweden
Primary sponsor type
University
Name
University of Otago
Address
23A Mein Street
PO BOX 7343
Wellington South
Wellington 6242
Country
New Zealand
Secondary sponsor category [1] 288532 0
None
Name [1] 288532 0
Address [1] 288532 0
Country [1] 288532 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291574 0
University of Otago Human Ethics Committee
Ethics committee address [1] 291574 0
PO Box 56

Dunedin 9054
Ethics committee country [1] 291574 0
New Zealand
Date submitted for ethics approval [1] 291574 0
27/08/2014
Approval date [1] 291574 0
29/09/2014
Ethics approval number [1] 291574 0
H14/111
Ethics committee name [2] 297576 0
Drum Tower Hospital Ethics Committee
Ethics committee address [2] 297576 0
Drum tower hospital,
No. 321 Zhongshan Avenue
Nanjing
China
zip code: 210008.
Ethics committee country [2] 297576 0
China
Date submitted for ethics approval [2] 297576 0
Approval date [2] 297576 0
25/03/2016
Ethics approval number [2] 297576 0
protocol number 2016-019-12

Summary
Brief summary
Background

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 is high enough to cause severe reactions (moist desquamation). This is the case for 40-60% of breast and head and neck cancer patients. 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 showed that soft silicone dressings decreased skin reaction severity in breast cancer patients in New Zealand (1–3). The dressings adhere closely to the folds and creases of the skin and prevent friction damage (due to items of clothing or other skin parts) to the radiation damaged skin (4).

Damage protection by the dressings is best when they are used from the start of radiation treatment, resulting in a 90% reduction of skin reaction severity and a complete lack of moist desquamation (3). However, using dressings from the start of radiation treatment is not always practical. If started when the skin shows faint erythema (redness), the dressings decrease skin reaction severity up to 40% but do not affect moist desquamation rates (1,2). Mepitel Film has so far only been used in the preventative setting in breast cancer patients who received a skin dose of less than 40Gy.

In addition to investigating the effect of Mepitel Film, we also want to measure the effect of patient stress levels on skin reaction severity. Our previous trial showed that breast cancer patients who are highly stressed during their course of radiation therapy have a much higher chance of developing moist desquamation. We wish to confirm these findings in a cohort of head and neck cancer patients.

References
1. Diggelmann K, Zytkovicz A, Tuaine J, Bennett N, Kelly L, Herst P. Mepilex Lite dressings for the management of radiation-induced erythema: a systematic inpatient controlled clinical trial. Brit J Radiol [Internet]. 2010 Nov [cited 2012 May 9];83(995):971–8. Available from: http://www.ncbi.nlm.nih.gov/pubmed/20647511
2. Paterson D, Poonam P, Bennett N, Peszynski R, Van Beekhuizen M, Jasperse M, et al. Randomized Intra-patient Controlled Trial of Mepilex Lite Dressings versus Aqueous Cream in Managing Radiation-Induced Skin Reactions Postmastectomy. J Cancer Sci Ther [Internet]. 2012 [cited 2013 Jul 3];04(11):347–56. Available from: http://www.omicsonline.org/1948-5956/JCST-04-347.digital/JCST-04-347.html
3. Herst P, Bennet N, Sutherland A, Peszynski R, Paterson D, Jasperse M. Prophylactic use of Mepitel Film completely prevents radiation-induced moist desquamation in an intra-patient controlled RCT of 78 breast cancer patients in New Zealand. Radiother Oncol. 2014;in press.
4. Herst P. Protecting the radiation-damaged skin from friction: a mini review. J Med Radiat Sci [Internet]. 2014 Jun 28 [cited 2014 Jul 4];61(2):119–25. Available from: http://doi.wiley.com/10.1002/jmrs.46




Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50966 0
Dr Patries Herst
Address 50966 0
Department of Radiation Therapy University of Otago, Wellington POBox 7343 Wellington South 6242
Country 50966 0
New Zealand
Phone 50966 0
+64-4-3855475
Fax 50966 0
+64-4-3855375
Email 50966 0
patries.herst@otago.ac.nz
Contact person for public queries
Name 50967 0
Dr Patries Herst
Address 50967 0
Department of Radiation Therapy University of Otago, Wellington POBox 7343 Wellington South 6242
Country 50967 0
New Zealand
Phone 50967 0
+64-4-3855475
Fax 50967 0
+64-4-3855375
Email 50967 0
patries.herst@otago.ac.nz
Contact person for scientific queries
Name 50968 0
Dr Patries Herst
Address 50968 0
Department of Radiation Therapy University of Otago, Wellington POBox 7343 Wellington South 6242
Country 50968 0
New Zealand
Phone 50968 0
+64-4-3855475
Fax 50968 0
+64-4-3855375
Email 50968 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