Although acute radiation dermatitis is a common side-effect of radiotherapy, currently there is no general consensus about its prevention or treatment of choice. In this study, we aimed to measure the impact of Chamomile in prevention of radiation dermatitis. This study is triple blind randomized placebo- controlled trial. The sample size in each group, 30 cases were considered. Patients were randomly divided to either drug or placebo groups . Cream will be used three times daily for 6 consecutive weeks. Patients on days 3, 6, 9, 12, 15, 18, 21, 24 and 2 weeks after treatment are examined and the incidence and severity of dermatitis visited the RTOG criteria will be reported.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201107207074N1
Registration date:2011-10-05, 1390/07/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-10-05, 1390/07/13
Registrant information
Name
Fatemeh Jourkesh
Name of organization / entity
Nursing Midwifery Jundishapur
Country
Iran (Islamic Republic of)
Phone
+98 78 1224 0960
Email address
jourkesh.f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Jondi Shapour University of Medical Sciences
Expected recruitment start date
2011-02-20, 1389/12/01
Expected recruitment end date
2011-07-23, 1390/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of German chamomile(Matricaria recutita L.) extract in the prevention of acute radiation dermatitis in the patients with breast cancer
Public title
The effect of chamomile extract for acute radiation dermatitis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria; Adults over 18 years; breast cancer diagnosis in a Syth is approved by the oncologist; Patients who underwent a radical mastectomy and breast have been; Not having a mental illness; not using the drug topically on affected area of acute dermatitis; a chronic skin disease such as pemphigus and no collagen vascular disease; the disease weakens the immune system; a lack of diabetes; Old burn scars in the area of radiation; no use in patients bolus; not receiving concurrent chemotherapy with radiation; the lack of sensitivity to drug testing patch; 5000 cGy total dose of radiation; the depth of the cm 7.5-9.5; mass physical between 19.8 to 26; is able to communicate out of this situation; not wanting to continue the intervention; surgery, infection and bleeding at the time of the study; the incidence of drug allergy
Age
From 18 years old to 100 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Joundi Shapor University
Street address
Joundi Shapor University, Golestan street, Ahwaz
City
Ahwaz
Postal code
Approval date
2011-02-20, 1389/12/01
Ethics committee reference number
Eth155
Health conditions studied
1
Description of health condition studied
Radiation acute dermatitis
ICD-10 code
L24
ICD-10 code description
Irritant contact dermatitis
2
Description of health condition studied
Breast cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
Intensity of radiation acute dermatitis
Timepoint
3, 6, 9, 12, 15, 18, 21, 24 days and 2 week after completion of treatment
Method of measurement
RTOG criteria based on measurements that can be graded from 0 to 4
Secondary outcomes
1
Description
Drug allergy
Timepoint
During treatment
Method of measurement
Czech list
Intervention groups
1
Description
Chamomile extract is prescribed in the Basic Cold Cream, 4% in the cream, 3 times a day on the first day of radiation therapy to radiation treatment two weeks after
Category
Prevention
2
Description
Control: placebo administered in combination with the base color and allowed Cold Cream orally 3 times a day on the first day of radiation therapy to radiation treatment two weeks after
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Radiotherapy Department, Golestan Hospital, Ahwaz
Full name of responsible person
Fatemeh Jourkesh
Street address
Golestan Hospital, Golestan street, Ahwaz
City
Ahwaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Ahwaz University of Medical Sciences
Full name of responsible person
Dr. Mostafa Feghhi
Street address
Nursing and Midwifery College, Ahwaz Jondi Shapur University of Medical Sciences, Golestan street, Ahwaz
City
Ahwaz.
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Ahwaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
University of Medical Sciences
Full name of responsible person
Fatemeh Jourkesh
Position
Master Nursing
Other areas of specialty/work
Street address
Nursing and Midwifery College, Ahwaz Jondi Shapur University of Medical Av, Golestan street, Ahwaz
City
Ahwaz
Postal code
Phone
+98 78 1224 0960
Fax
Email
jourkesh.f@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahwaz Jondi Shapur University of Medical Sciences
Full name of responsible person
Fatemeh Jourkesh
Position
Master Nursing
Other areas of specialty/work
Street address
Ahwaz Jondi Shapur University of Medical Sciences, Golestan street, Ahwaz
City
Ahwaz
Postal code
Phone
+98 78 1224 0960
Fax
Email
jourkesh.f@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Jondi Shapour Ahwaz University
Full name of responsible person
Fatemeh Jourkesh
Position
Master Nursing
Other areas of specialty/work
Street address
Ahwaz Jondi Shapur University of Medical Sciences, Golestan street, Ahwaz
City
Ahwaz
Postal code
Phone
+98 78 1224 0960
Fax
Email
jourkesh.f@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)