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Trial registered on ANZCTR


Registration number
ACTRN12613000165785
Ethics application status
Approved
Date submitted
23/01/2013
Date registered
11/02/2013
Date last updated
24/03/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of Calendula lotion in reducing the severity of radiation induced dermatitis in women undergoing radiotherapy for breast cancer
Scientific title
A single-blinded randomised controlled trial to determine the effect of topical application of Calendula officinalis based lotion on the prevalence of clinically significant radiation induced dermatitis in women undergoing radiotherapy for breast cancer.
Secondary ID [1] 281831 0
Nil
Universal Trial Number (UTN)
U1111-1138-8279
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Radiation induced dermatitis 288185 0
Breast cancer 288186 0
Condition category
Condition code
Skin 288550 288550 0 0
Dermatological conditions
Cancer 288551 288551 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Calendula officinalis lotion (marigold extract 32%v/v) topically applied to skin twice a day every day of the week during radiotherapy treatment (typically a 5 week period) and for up to 6 weeks after treatment. Participants will be instructed to apply lotion generously to entire irradiated skin using an amount approximately in size to a 20cent-50cent piece (dependent on physique).
Intervention code [1] 286386 0
Prevention
Intervention code [2] 286387 0
Treatment: Other
Comparator / control treatment
Sorbolene lotion with 10% glycerine topically applied to skin twice a day every day of the week during radiotherapy treatment (typically a 5 week period) and for up to 6 weeks after treatment. Participants will be instructed to apply lotion generously to entire irradiated skin using an amount approximately in size to a 20cent-50cent piece (dependent on physique).
Control group
Active

Outcomes
Primary outcome [1] 288709 0
Severity of radiation induced dermatitis will be assessed clinically and graded using the Radiation Therapy Oncology Group (RTOG) and the European Organization for Research and Treatment of Cancer (EORTC) acute radiation morbidity scale for skin.
Timepoint [1] 288709 0
Weekly throughout the active treatment (radiation) and at post-treatment follow-up at up to 6 weeks after conclusion of treatment
Secondary outcome [1] 300797 0
Radiation Induced Skin Reaction Assessment Scale Part A and Part B (RISRAS)
Timepoint [1] 300797 0
Weekly throughout the active treatment (radiation) and at post-treatment follow-up at up to 6 weeks after conclusion of treatment
Secondary outcome [2] 301088 0
Interruptions to treatment as documented by treating radiation oncologist on treatment plan
Timepoint [2] 301088 0
At any time through the active treatment (radiation)
Secondary outcome [3] 301089 0
Radiation Schedule (dose/fraction) as documented by radiotherapists on treatment plan
Timepoint [3] 301089 0
End of treatment follow-up review
Secondary outcome [4] 301090 0
Participant reported ease of application of topical lotion as assessed by investigator administered questionnaire
Timepoint [4] 301090 0
End of treatment follow-up review
Secondary outcome [5] 301091 0
Dermatis reaction to regularly applied topical lotion, judged by treating radiation oncologists to not be related to radiation therapy, as documented in treatment plan
Timepoint [5] 301091 0
Any stage throughout study

Eligibility
Key inclusion criteria
Women who have undergone lumpectomy or mastectomy and are due to undergo post-surgical radiotherapy for
breast cancer using standard treatment pathways
No concurrent chemotherapy
Informed consent
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Known allergy to calendula/officinalis or sorbolene
Salicylate sensitivity
Previous radiation to breast
History of skin/dermatitis condition
On anticoagulant therapy
Pregnant or breast feeding
Reaction to skin test

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Following consent, participant details faxed to Pharmacy who will randomise according to randomisation schedule. Treatment (bottles) labelled in a blinded manner with reidentifiable study participant number and will be dispensed by Pharmacy.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation schedule
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Descriptive and inferential statistical
Percent of participants with Grade 2, 3 or 4 skin toxicity will be calculated with 95% confidence limits.
Test primary hypothesis by difference in proportions of participants with Grade 2 or greater skin toxicity using Chi-Square statistic and relative risk estimates.
Secondary analyses: Prevalance estimates of pain and other parameters. Independent associations between covariates and outcomes and multivariate logistic regression analysis for outcome clinically significant RID and the key covariates to determine risk factors for RID.

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 in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 469 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 6220 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 286615 0
Hospital
Name [1] 286615 0
Royal Adelaide Hospital Research Fund
Address [1] 286615 0
Research Secretariat
L3 IMVS Building
North Terrace campus
Adelaide SA 5000
Country [1] 286615 0
Australia
Primary sponsor type
Individual
Name
Dr Michael Penniment
Address
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 285401 0
None
Name [1] 285401 0
Address [1] 285401 0
Country [1] 285401 0
Other collaborator category [1] 277259 0
Individual
Name [1] 277259 0
Eileen Giles
Address [1] 277259 0
University of South Australia
North Terrace
Adelaide SA 5000
Country [1] 277259 0
Australia
Other collaborator category [2] 277260 0
Individual
Name [2] 277260 0
Margaret McGee
Address [2] 277260 0
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country [2] 277260 0
Australia
Other collaborator category [3] 277261 0
Individual
Name [3] 277261 0
Dr Yee Chai
Address [3] 277261 0
Pharmacy, Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country [3] 277261 0
Australia
Other collaborator category [4] 277262 0
Individual
Name [4] 277262 0
Dr Nicole Moore
Address [4] 277262 0
Dame Roma Mitchell Cancer Research Laboratories
University of Adelaide
Hanson Institute Bldg, Frome Rd
Adelaide SA 5000
Country [4] 277262 0
Australia
Other collaborator category [5] 277263 0
Individual
Name [5] 277263 0
Dr Raghu Gowda
Address [5] 277263 0
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country [5] 277263 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288688 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [1] 288688 0
L3 Hanson Institute
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Ethics committee country [1] 288688 0
Australia
Date submitted for ethics approval [1] 288688 0
Approval date [1] 288688 0
09/05/2012
Ethics approval number [1] 288688 0
120322

Summary
Brief summary
The main aim of this study is to compare two products for preventing or reducing the severity of radiation induced dermatitis (RID). RID is a common side effect of radiation therapy. RID is characterised by skin redness and in severe cases, the skin thins and begins to weep and may be susceptible to infection. With ongoing radiation, the skin condition and appearance often worsens.

This trial aims to compare sorbolene cream which is the standard product that is recommended for use by patients at the Royal Adelaide Hospital with a lotion containing extract of Calendula officinalis (marigold flower), called Calendula lotion. Calendula is reported to have anti-inflammatory properties and may encourage skin healing. The hypothesis for the study is that Calendula lotion offers significant benefits compared to sorbolene when used for the prevention or treatment of RID.

Who is it for?

This study is open to women 18 years and over who have undergone prior lumpectomy or mastectomy and are due to undergo post-surgical radiotherapy for breast cancer using standard treatment pathways. Participants will need to provide informed consent, and not be undergoing any concurrent chemotherapy at the time of participation. Full exclusion criteria for this study can be found in the relevant section of this form.

Trial details

You will be randomised to receive either Calendula officinalis lotion (marigold extract 32%v/v) or Sorbolene lotion with 10% glycerine, which will be topically applied to skin twice a day every day of the week during radiotherapy treatment (typically a 5 week period) and for up tp 6 weeks. Participants will be instructed to apply lotion generously to entire irradiated skin using an amount approximately in size to a 20cent-50cent piece (dependent on physique).
Trial website
Trial related presentations / publications
Public notes
Data analysis and report preparation underway.

Contacts
Principal investigator
Name 37306 0
Dr Michael Penniment
Address 37306 0
Department of Radiation Oncology
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 37306 0
Australia
Phone 37306 0
+61 8 8222 4800
Fax 37306 0
Email 37306 0
michael.penniment@sa.gov,au
Contact person for public queries
Name 37307 0
Ms Margaret McGee
Address 37307 0
Discipline of Medicine
Level 6, Adelaide Health and Medical Sciences Building
The University of Adelaide
Adelaide SA 5005
Country 37307 0
Australia
Phone 37307 0
61 8 8313 0514
Fax 37307 0
NA
Email 37307 0
margaret.mcgee@adelaide.edu.au
Contact person for scientific queries
Name 37308 0
Ms Margaret McGee
Address 37308 0
Discipline of Medicine
Level 6, Adelaide Health and Medical Sciences Building
The University of Adelaide
Adelaide SA 5005
Country 37308 0
Australia
Phone 37308 0
61 8 8313 0514
Fax 37308 0
NA
Email 37308 0
margaret.mcgee@adelaide.edu.au

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