ANZCTR - Registration

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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]

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

Condition category

Condition code

Cancer

Any cancer

Skin

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]

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]

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]

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]

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]

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]

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]

Secondary outcome [3]

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]

Secondary outcome [4]

Treatment interruptions (as determined by the treating medical staff)
- Yes/ No

Timepoint [4]

Secondary outcome [5]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

15/10/2012

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

172

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Office of Health and Medical Research, Queensland Health

Address [1]

Level 13, Queensland Health Building, 147 - 163 Charlotte Street, Brisbane QLD 4000

Country [1]

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]

Commercial sector/Industry

Name [1]

Moogoo Skin Care

Address [1]

4/6 Parkside Dr, Tweed Heads South, NSW 2486

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Brisbane and Women's Hospital Human Research Ethics Committee

Ethics committee address [1]

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]

Australia

Date submitted for ethics approval [1]

13/03/2012

Approval date [1]

23/05/2012

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Raymond Chan

Address

Level 2, Blg 34, Royal Brisbane and Women's Hospital, Herston, QLD 4029, Australia

Country

Australia

Phone

+61430857066

Fax

[email protected]

Contact person for scientific queries

Name

Raymond Chan

Address

Level 2, Blg 34, Royal Brisbane and Women's Hospital, Herston, QLD 4029, Australia

Country

Australia

Phone

+61430857066

Fax

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

Current Study Results

No documents have been uploaded by study researchers.

Update to Study Results

Doc. No.	Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
4359	Study results article	Yes		Chan R, Mann J, Keller J, Cheuk R, Tripcony L, Bla... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	A double-blind randomised controlled trial of a natural oil-based emulsion (Moogoo Udder Cream) containing allantoin versus aqueous cream for managing radiation-induced skin reactions in patients with cancer.	2012	https://dx.doi.org/10.1186/1748-717X-7-121

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically