Purpose: Given the wide prevalence of breast cancer in females and radiation- induced dermatitis, a randomized trial designed to evaluate prophylactic effect of aloe vera gel on radiation induced dermatitis. Design: this is a randomized phase 2 clinical trial. Setting and conduct: Targeted population include 100 patients that receive radiotherapy in Namazee hospital. Patients randomly assign to intervention group or control group. Both groups receive radiotherapy. Then intervention group receive topical aloe vera gel on radiation therapy field twice a day and control group receive no treatment. The patients have been examined weekly and dermatitis grade is compared in both groups finally. Inclusion criterias include beast cancer patients with partial mastectomy, all ages, Female, No previous radiotherapy to breast area. Exclusion criterias include Having poor follow up and Using other local drugs concurrently. Intervention: all patients receive standard radiotherapy and Aloe vera gel was applied in intervention group. The main outcome variables: The endpoints of this study include grading of dermatitis and treatment interruption.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016082129451N1
Registration date:2016-10-02, 1395/07/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-10-02, 1395/07/11
Registrant information
Name
Behnam Kadkhodaei
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4320
Email address
stud5479613324@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
anamis compony
Expected recruitment start date
2015-11-30, 1394/09/09
Expected recruitment end date
2016-02-28, 1394/12/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of prophylactic effect of aloe vera gel on radiation induced dermatitis in breast cancer patients.
Public title
Evaluation of prophylactic effect of aloe vera gel on radiation induced dermatitis in breast cancer patients.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: New diagnosed breast cancer patients with partial mastectomy who need to receive radiation therapy; All ages; Female; No previous radiotherapy to breast area; No systemic and dermatologic disease; The median time interval between end of chemotherapy and the beginning of irradiation ranged between 3 and 4 weeks. Exclusion criteria: Having poor follow up; Stopping radiotherapy by patient herself; The patient refuse to using aloe Vera gel; Using other local drugs concurrently.
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz medical school ' Ethics Committee
Street address
Zand AVE, Namazee SQ, Shiraz medical school
City
Shiraz
Postal code
Approval date
2016-08-27, 1395/06/06
Ethics committee reference number
IR.SUMS.MED.REC.1395.15
Health conditions studied
1
Description of health condition studied
Breast cancer
ICD-10 code
C50.9
ICD-10 code description
Breast, unspecified
Primary outcomes
1
Description
Grading of dermatitis
Timepoint
weekly
Method of measurement
Rtog scoring for radiation induced dermatitis
Secondary outcomes
1
Description
Treatment interruption
Timepoint
weekly
Method of measurement
Review of the patient's medical file
Intervention groups
1
Description
Intervention group: all breast cancer patients with partial mastectomy that assigned to this group randomly and all of them receive standard radiotherapy. radiation doses was 50 Gy in 25 fractions by linac machine ( 6mv photon) and Aloe vera gel was applied twice a day with a thickness of 1-2 mm on the radiation therapy field from first day. 6-hour time period is recommended between two application of aloe vera gel.
Category
Treatment - Drugs
2
Description
Control group: All breast cancer patients with partial mastectomy that assigned to this group randomly, should receive radiotherapy. Radiation doses was 50 Gy in 25 fractions by linac machine (6mv photon).The patients did not receive any medication .
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazee Teaching Hospital
Full name of responsible person
Dr.Behnam kadkhodaei
Street address
Zand AVE, Namazee SQ
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Sciences
Full name of responsible person
Dr.Ali Poost Foroush Fard
Street address
Zand AVE, Central building
City
Shiraz
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, Shiraz University of Medical Sciences