Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000837820
Ethics application status
Approved
Date submitted
2/08/2012
Date registered
9/08/2012
Date last updated
13/08/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The efficacy of topical Alpha ointment (containing natural Henna) on healing of radiation-induced dermatitis in breast cancer patients
Scientific title
The efficacy of topical Alpha ointment (containing natural Henna) compared to topical hydrocortisone 1% on healing of radiation-induced dermatitis in breast cancer patients
Secondary ID [1] 280963 0
No secondary ID
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 287073 0
Condition category
Condition code
Cancer 287396 287396 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Postmastectomy radiation portals are composed of chest wall fields in all patients and supraclavicular, post-axillary and internal mammary fields in most of them. All patients in both arms are treated with conventional fractionation with similar technique with a daily fraction of 1.8-2 Gy, with five fractions per week and over a standard duration of total of 5-6 weeks (based on physician choice). The radiation portals were composed of chest wall fields in all patients and supraclavicular, post-axillary and internal mammary fields in most of them. All patients will receive a total dose of 45-50.4 Gy.
patients in study arm will apply themselves 1 millimeter thickness of topical Alpha ointment twice daily (n = 30) immediately after completing postmastectomy chest wall radiotherapy with a median dose of 45-50 Gy. In addition, all patients are recommended to take daily chest wall simple washing with mild soap.
Intervention code [1] 285402 0
Treatment: Other
Intervention code [2] 285449 0
Prevention
Comparator / control treatment
patients in control arm will apply themselves 1 millimeter thickness of topical hydrocortisone 1% ointment twice daily (n = 30) immediately after completing postmastectomy chest wall radiotherapy with a median dose of 45-50 Gy. In addition, all patients are recommended to take daily chest wall simple washing with mild soap.
Control group
Active

Outcomes
Primary outcome [1] 287663 0
The primary endpoint of the study is the rate of healing of radiation dermatitis.
Timepoint [1] 287663 0
Dermatitis grade will be determined according to the Common Terminology Criteria for Adverse Events version 4.0. The dermatitis area (cm2) will be measured independently by 2 physicians in each exam (weekly) till 4 weeks after starting intervention.
Secondary outcome [1] 298603 0
Nil
Timepoint [1] 298603 0
Nil

Eligibility
Key inclusion criteria
Eligible patients have to have newly pathologically proven diagnosed locally advanced breast cancer treated with modified radical mastectomy followed by sequential adjuvant chemotherapy and chest wall radiotherapy (45-50.4 Gy), and developed grade 2 and/or 3 radiation-induced dermatitis.
Minimum age
20 Years
Maximum age
75 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria were any history of collagen vascular diseases, diabetes mellitus, taking any drugs interacting wound healing process, like systemic steroids, previous history of chest wall radiotherapy and concurrent use of chemotherapy. All patients had to sign a consent form approved by the local research ethics committee before participating in the study.

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)
Randomization is performed by computer at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization by using a randomization table from a statistic book.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Nil
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
9/03/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 4381 0
Iran, Islamic Republic Of
State/province [1] 4381 0

Funding & Sponsors
Funding source category [1] 285750 0
University
Name [1] 285750 0
Shiraz University of Medical Sciences
Country [1] 285750 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
Shiraz University of Medical Sciences
Address
Shiraz University of Medical Sciences, Shiraz 71936, Iran
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 284577 0
None
Name [1] 284577 0
Address [1] 284577 0
Country [1] 284577 0
Iran, Islamic Republic Of

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287757 0
The local Research Ethics Committee
Ethics committee address [1] 287757 0
The Research Ethics Committee of Shiraz University of Medical Sciences, Shiraz University of Medical Sciences, Shiraz 71936, Iran
Ethics committee country [1] 287757 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 287757 0
14/06/2012
Approval date [1] 287757 0
25/07/2012
Ethics approval number [1] 287757 0
Nil

Summary
Brief summary
Radiotherapy is an essential element in the treatment of patients with breast cancer. The vast majority of patients with locally advanced disease need to receive postmastectomy adjuvant radiotherapy to the chest wall and many of them develop dermatitis. Acute radiation-induced skin reaction (radiation dermatitis) develops during the radiation process or a short time after radiotherapy completion. Dermatitis or severe skin reaction of irradiated chest wall can influence the patients’ quality of life negatively; lowers their tolerance for continuing treatment; and leads to treatment delay; and results in treatment failure. Although some various managements have been suggested for radiation induced dermatitis, to date, none of them have been proved as the standard of the care. One of proposed treatments for radiation-induced dermatitis is topical corticosteroids. The anti-inflammatory effects of corticosteroids may play an important role in relieving the patients’ symptoms. The efficacy of Henna (Lawsonia inermis linn) compounds in the treatment of burning and infectious wounds has been shown in different studies. Meanwhile, their antioxidant and antimicrobial activity in wound healing has been introduced in some studies. Currently, there is no standard approach to skin care in cancer patients developing radiation dermatitis. This study aimed to compare the efficacy and safety of topical Alpha ointment to topical hydrocortisone 1% ointment on healing of radiation-induced dermatitis in breast cancer patients undergoing postmastectomy chest wall radiotherapy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34376 0
Address 34376 0
Country 34376 0
Phone 34376 0
Fax 34376 0
Email 34376 0
Contact person for public queries
Name 17623 0
Mohammad Mohammadianpanah
Address 17623 0
Department of Radiation Oncology, Namazi Hospital, Shiraz University of Medical Sciences, Shiraz 71936-13311, Iran
Country 17623 0
Iran, Islamic Republic Of
Phone 17623 0
+98 711 6474320
Fax 17623 0
+98 711 6474320
Email 17623 0
[email protected]
Contact person for scientific queries
Name 8551 0
Mohammad Mohammadianpanah
Address 8551 0
Department of Radiation Oncology, Namazi Hospital, Shiraz
Country 8551 0
Iran, Islamic Republic Of
Phone 8551 0
+98 711 6474320
Fax 8551 0
+98 711 6474320
Email 8551 0
[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
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