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Trial registered on ANZCTR


Registration number
ACTRN12612000568819
Ethics application status
Approved
Date submitted
24/05/2012
Date registered
28/05/2012
Date last updated
14/11/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A double-blind randomised controlled trial of a natural oil-based emulsion containing allantoin versus aqueous cream for managing radiation-induced skin reactions in patients with cancer
Scientific title
The effectiveness of a natural oil-based emulsion containing allantoin versus aqueous cream for improving the outcomes associated with radiation-induced skin reactions in patients with cancer
Secondary ID [1] 280548 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Radiation-induced skin reactions in patients with cancer 286546 0
Condition category
Condition code
Cancer 286815 286815 0 0
Any cancer
Skin 286816 286816 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A natural oil-based emulsion containing allantoin

A natural oil-based emulsion, as known as Moogoo Udder Cream (Registered Trademark), is a Queensland owned product that comprises allantoin, purified water, sweet almond oil, olive oil, rice bran oil, emulsifying wax, milk protein, aloe vera, vitamin E, glycerol caprylate, piroctone alamine and guarsilk.

Patients will be asked to start topical application of their allocated cream on the area of skin being irradiated at the onset of radiotherapy, twice a day or more as needed depending on the occurrence of RISR and pain, until the skin reaction subsides. The amount of cream dispensed to each patient will be recorded throughout treatment. If moist desquamation occurs, the topical preparation will be discontinued in the area of skin breakdown and dressings will be applied until the wound heals as per standard care. Patients will be asked to still continue with the topical preparation onto irradiated area that has no breakdown. All participants are given written instructions on how to apply the allocated treatment.
Intervention code [1] 284924 0
Treatment: Other
Comparator / control treatment
Aqueous cream

Aqueous Cream is a light, paraffin-based emulsion that contains liquid paraffin, white soft paraffin, purified water, emulsifying wax containing sodium lauryl sulphate, cetostearyl alcohol, chlorocresol.


Patients will be asked to start topical application of their allocated cream on the area of skin being irradiated at the onset of radiotherapy, twice a day or more as needed depending on the occurrence of RISR and pain, until the skin reaction subsides. The amount of cream dispensed to each patient will be recorded throughout treatment. If moist desquamation occurs, the topical preparation will be discontinued in the area of skin breakdown and dressings will be applied until the wound heals as per standard care. Patients will be asked to still continue with the topical preparation onto irradiated area that has no breakdown. All participants are given written instructions on how to apply the allocated treatment.
Control group
Active

Outcomes
Primary outcome [1] 287183 0
Severity of skin reaction (assessment by the clinician). The Common Terminology Criteria for Adverse Events (CTCAE- Version 4.0) will be used to assess the severity of skin reactions. This scale ranges from 0-5, lower scores representing less severe skin reactions, and higher scores representing more severe skin reactions.
Timepoint [1] 287183 0
Baseline (i.e. day-7 to day 0 of radiation treatment), weekly during radiation treatment (i.e. Days 5, 10, 15, 20, 25, 30 of radiation treatment), 4 weeks after radiation treatment (i.e. Day 28 post radiation treatment).
Secondary outcome [1] 297569 0
Quality of life (skin specific) (self-administered by the patient), as assessed with Skindex-16.
- Skindex-16 is a 16-item self-administered survey instrument to measure the effects of skin condition on quality of life.
Timepoint [1] 297569 0
This outcome will be assessed at baseline (i.e. day-7 to day 0 of radiation treatment), weekly during radiation treatment (i.e. Days 5, 10, 15, 20, 25, 30 of radiation treatment), Week 1,2,3 post treatment (i.e. Days 5, 10, 15 post radiation treatment), 4 weeks after radiation treatment (i.e. Day 28 post radiation treatment).
Secondary outcome [2] 297590 0
Modified Brief Pain Inventory (self- administered by the patient)
- This study will use three measures from the Brief Pain Inventory (BPI), those of the average, best, and worst pain, and pain relief scores from the preceding seven days. The participant will be asked to rate their pain level at the irradiated area. The time of interest of the original BPI is modified from the past 24 hours to the past 7 days for the specific purpose of this study. The scale of 0 to 10 is simple for patients to use and reflects common clinical assessment of pain.
Timepoint [2] 297590 0
This outcome will be assessed at baseline (i.e. day-7 to day 0 of radiation treatment), weekly during radiation treatment (i.e. Days 5, 10, 15, 20, 25, 30 of radiation treatment), Week 1,2,3 post treatment (i.e. Days 5, 10, 15 post radiation treatment), 4 weeks after radiation treatment (i.e. Day 28 post radiation treatment).
Secondary outcome [3] 297591 0
Itching (self- administered by the patient)
- Itching will be scored on a numeric analogue scale of 0-10 in the treated skin (0= no itching at all), (10= itching as bad as you can imagine).
Timepoint [3] 297591 0
This outcome will be assessed at baseline (i.e. day-7 to day 0 of radiation treatment), weekly during radiation treatment (i.e. Days 5, 10, 15, 20, 25, 30 of radiation treatment), Week 1,2,3 post treatment (i.e. Days 5, 10, 15 post radiation treatment), 4 weeks after radiation treatment (i.e. Day 28 post radiation treatment).
Secondary outcome [4] 297592 0
Treatment interruptions (as determined by the treating medical staff)
- Yes/ No
Timepoint [4] 297592 0
This outcome will be assessed at baseline (i.e. day-7 to day 0 of radiation treatment), weekly during radiation treatment (i.e. Days 5, 10, 15, 20, 25, 30 of radiation treatment), Week 1,2,3 post treatment (i.e. Days 5, 10, 15 post radiation treatment), 4 weeks after radiation treatment (i.e. Day 28 post radiation treatment).
Secondary outcome [5] 297593 0
Adverse events. Any adverse events will be reported by the investigators. Adverse events will include allergic reactions (e.g. redness or blisters) from the allocated treatment and will be assessed using the Common Toxicity Criteria for Adverse Events version 4.0. (CTCAE v4)
Timepoint [5] 297593 0
This outcome will be assessed at baseline (i.e. day-7 to day 0 of radiation treatment), weekly during radiation treatment (i.e. Days 5, 10, 15, 20, 25, 30 of radiation treatment), Week 1,2,3 post treatment (i.e. Days 5, 10, 15 post radiation treatment), 4 weeks after radiation treatment (i.e. Day 28 post radiation treatment).

Eligibility
Key inclusion criteria
Participants in this study will all be patients receiving radical radiotherapy for lung cancer, breast cancer and head and neck cancer at the Royal Brisbane and Women’s Hospital . A sample of consecutive eligible and consented patients will be recruited into the study.
1. Age >18 years
2. Patients who have a definitive diagnosis of breast cancer, lung cancer or head and neck cancer
3. Patients who are receiving radiotherapy (>50 Gy) either as primary treatment or postoperative treatment to their chest, breast or head and neck.
Minimum age
18 Years
Maximum age
99 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients who are unable to consent
2. Patients with pre-existing skin rash, ulceration or open wound in the treatment area
3. Patients with known allergic and other systemic skin diseases even not directly affecting irradiated fields.
4. Patients with any known allergic reactions towards any ingredient of either the Moogoo Udder Cream (Registered Trademark) or the aqueous cream and failed the patch test.

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)
Allocation concealment and blinding
After the research nurse has obtained the patient’s consent. The research nurse will then allocate participants to either receive Cream 1 (Group 1), or receive Cream 2 (Group 2) according to the generated sequence. This proposed study is a double-blind study. Blinding will be accomplished by not disclosing to the research nurse, medical officers, radiation therapists, nurses or participants which preparation used for skin treatment for each of the participants.

Both topical preparations: Moogoo Udder Cream (Registered Trademark) and aqueous cream are white in colour, have similar consistency, and have no distinct odour. There are no other differentiating features. Both topical preparations will be provided and coded as Cream 1 or Cream 2 by the manufacturer in identical containers. The manufacturer will only disclose what Cream 1 and Cream 2 are at the completion of data collection. Subsequently, baseline data will be collected.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation
Blocked randomisation will be performed by a computer generated random number list prepared by an investigator who has no clinical involvement in the trial. Stratification by irradiated sites (breast, lung or head and neck), BMI categories (underweight <18.50, normal = 18.50-24.99, overweight =25-29.9, obesity>30) and smoking status (smoking and non-smoking) will be carried out.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
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 in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 285315 0
Government body
Name [1] 285315 0
Office of Health and Medical Research, Queensland Health
Address [1] 285315 0
Level 13, Queensland Health Building, 147 - 163 Charlotte Street, Brisbane QLD 4000
Country [1] 285315 0
Australia
Primary sponsor type
Individual
Name
Raymond Chan
Address
Level 2, Blg 34, Royal Brisbane and Women's Hospital, Herston, QLD 4029
Country
Australia
Secondary sponsor category [1] 284172 0
Commercial sector/Industry
Name [1] 284172 0
Moogoo Skin Care
Address [1] 284172 0
4/6 Parkside Dr, Tweed Heads South, NSW 2486
Country [1] 284172 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287329 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 287329 0
Human Research Ethics Office, Level 7, Block 7, Royal Brisbane and Women's Hospital, Metro North Health Service District, Herston, QLD 4029, Australia
Ethics committee country [1] 287329 0
Australia
Date submitted for ethics approval [1] 287329 0
13/03/2012
Approval date [1] 287329 0
23/05/2012
Ethics approval number [1] 287329 0
HREC/12/QRBW/90

Summary
Brief summary
This study aims to compare the efficacy of two different creams for the management of radiation-induced skin reactions in patients with cancer.

Who is it for?
You may be eligible to join this study if you are aged over 18 and are scheduled to undergo radical radiotherapy for lung cancer, breast cancer or head and neck cancer at the Royal Brisbane and Women’s Hospital. You will not be eligible if you have any pre-existing skin conditions or have any known allergies towards any ingredient of either of the creams.

Trial details
Participants in this trial will be randomly (by chance) allocated to one of two treatment groups. Participants in one group will apply a natural oil-based emulsion containing allantoin to their skin twice a day or more as needed depending on the occurrence of radiation-induced skin reactions. Participants in the other group will use an aqueous (water-based) cream instead. Participants will not know which cream they are using until the end of the trial.

Participants will be assessed prior to radiotherapy, weekly during radiotherapy, and four weeks after the completion of radiotherapy, in order to determine the effects of both creams in reducing radiation-induced skin reactions, improving pain, itching and quality of life.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 34219 0
Address 34219 0
Country 34219 0
Phone 34219 0
Fax 34219 0
Email 34219 0
Contact person for public queries
Name 17466 0
Raymond Chan
Address 17466 0
Level 2, Blg 34, Royal Brisbane and Women's Hospital, Herston, QLD 4029, Australia
Country 17466 0
Australia
Phone 17466 0
+61430857066
Fax 17466 0
Email 17466 0
email.rchan@gmail.com
Contact person for scientific queries
Name 8394 0
Raymond Chan
Address 8394 0
Level 2, Blg 34, Royal Brisbane and Women's Hospital, Herston, QLD 4029, Australia
Country 8394 0
Australia
Phone 8394 0
+61430857066
Fax 8394 0
Email 8394 0
email.rchan@gmail.com

No information has been provided regarding IPD availability
Summary results
No Results