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The assessment of Avena Sativa cream efficacy on skin reactions caused by radiotherapy in patients with breast cancer.

Protocol summary

Summary
Objective: The assessment of Avena Sativa cream efficacy on skin reactions caused by radiotherapy in patients with breast cancer. Interventions: After obtaining informed consent from the patient, at the first time of beginning radiotherapy we will recommend to patients use the cream which prepared from oat extract, three times a day each 8 hours daily (TDS), in the radiotherapy area, amount of one finger (FTU) will be applied uniformly with the index finger (considerably in different patients based on the extent of the lesion, this unit can be doubled) and for 3 hours, they must avoid washing the area. In the control group patients will use placebo (extract-free cream base). Then, The skin reactions such as tenderness, pain, itching, burning sensation, erythema, dry desquamation and the grade of dermatitis caused by radiotherapy will be examined at the intervals of 10 days after initiation of treatment (start of the major erythema reaction), 28 days after initiation of treatment (start of dry desquamation), on the last day of radiotherapy and after that in two times with one week interval, after the end of radiotherapy participants will be followed up. Then the data will be collected with RTOG questionnaire (to determine the grade of radio dermatitis) and researcher-made questionnaire which its validity and reliability will be determined.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201311015987N8
Registration date: 2014-08-05, 1393/05/14
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-08-05, 1393/05/14
Registrant information
Name
Shahrzad Ghiyasvandian
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
shghiyas@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2014-09-23, 1393/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The assessment of Avena Sativa cream efficacy on skin reactions caused by radiotherapy in patients with breast cancer.
Public title
The Effect of Oat Cream on skin reaction caused by radiotherapy.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Women with breast cancer; Without any skin lesion. Exclusion criteria: Patients with uncontrolled diabetes; Acquired immunodeficiency syndrome; A history of allergy to medicinal plants.
Age
No age limit
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)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Deputy Tehran University of Medical Sciences
Street address
sixth floor of the University Center, Qods St, Keshavarz Blvd. Tel: 88987382 - Fax: 88989664
City
Tehran
Postal code
Approval date
2014-05-19, 1393/02/29
Ethics committee reference number
130/405

Health conditions studied

1

Description of health condition studied
Breast Cancer
ICD-10 code
C50.9
ICD-10 code description
Malignant Neoplasm of Breast

Primary outcomes

1

Description
The grade of skin reaction caused by radioytherapy
Timepoint
At the intervals of 10 days after initiation of treatment , 28 days after initiation of treatment, on the last day of radiotherapy and after that in two times with one week interval, after the end of radiotherapy participants will be followed up
Method of measurement
Using the RTOG questionnaire and researcher-made questionnaire.

2

Description
Erythema
Timepoint
At the intervals of 10 days after initiation of treatment , 28 days after initiation of treatment, on the last day of radiotherapy and after that in two times with one week interval, after the end of radiotherapy participants will be followed up.
Method of measurement
Using the RTOG questionnaire and researcher-made questionnaire.

3

Description
Dry desquamation
Timepoint
At the intervals of 10 days after initiation of treatment , 28 days after initiation of treatment, on the last day of radiotherapy and after that in two times with one week interval, after the end of radiotherapy participants will be followed up.
Method of measurement
Using the RTOG questionnaire and researcher-made questionnaire.

4

Description
Itching
Timepoint
At the intervals of 10 days after initiation of treatment , 28 days after initiation of treatment, on the last day of radiotherapy and after that in two times with one week interval, after the end of radiotherapy participants will be followed up
Method of measurement
Ask the patient and using a researcher-made questionnaire

5

Description
Burning sensation
Timepoint
At the intervals of 10 days after initiation of treatment , 28 days after initiation of treatment, on the last day of radiotherapy and after that in two times with one week interval, after the end of radiotherapy participants will be followed up
Method of measurement
Ask the patient and using a researcher-made questionnaire

6

Description
Changes in daily activities
Timepoint
At the intervals of 10 days after initiation of treatment , 28 days after initiation of treatment, on the last day of radiotherapy and after that in two times with one week interval, after the end of radiotherapy participants will be followed up
Method of measurement
Ask the patient

7

Description
Tenderness
Timepoint
At the intervals of 10 days after initiation of treatment , 28 days after initiation of treatment, on the last day of radiotherapy and after that in two times with one week interval, after the end of radiotherapy participants will be followed up
Method of measurement
Ask the patient

Secondary outcomes

1

Description
Patchy and Distribution Moist Desquamation
Timepoint
At the intervals of 10 days after initiation of treatment , 28 days after initiation of treatment, on the last day of radiotherapy and after that in two times with one week interval, after the end of radiotherapy participants will be followed up
Method of measurement
Examination by a physician

2

Description
Drainage, Infection, Cellulitis
Timepoint
At the intervals of 10 days after initiation of treatment , 28 days after initiation of treatment, on the last day of radiotherapy and after that in two times with one week interval, after the end of radiotherapy participants will be followed up
Method of measurement
Examination by a physician

Intervention groups

1

Description
At the first time of beginning radiotherapy we will recommend to patients use the cream which prepared from oat extract, three times a day each 8 hours daily (TDS), in the radiotherapy area, amount of one finger (FTU) will be applied uniformly with the index finger ( considerably in different patients based on the extent of the lesion, this unit can be doubled) and for 3 hours, they must avoid washing the area.
Category
Treatment - Drugs

2

Description
In the control group patients will use placebo (extract-free cream base).
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Ramezanzade of Radiotherapy center in Yazd
Full name of responsible person
Antikchi Mahnaz, MSc student in Medical-Surgical Nursing The Tehran University,Iran
Street address
Shahid Motahari Avenue in front of the Rohaniyoon gas station, YAZD
City
yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Tehran University of Medical Science
Street address
sixth floor of the University Center, Qods St, Keshavarz Blvd. Tel: 88987382 - Fax: 88989664
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Science
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
Tehran University of Medical Sciences,School of Nursing and Midwifery
Full name of responsible person
Shahrzad ghiyasvandiyan
Position
Vice-Dean for Education Assistant Professor, Ph.D. in Nursing
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery, Tohid square
City
Tehran
Postal code
Phone
+98 21 6642 0739
Fax
Email
shghiyas@tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Science/School of Nursing and Midwifery
Full name of responsible person
Shahrzad ghiyasvandian
Position
Vice-Dean for Education Assistant Professor, Ph.D. in Nursing
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery, Tohid square
City
Tehran
Postal code
1419733171
Phone
+98 21 6642 0739
Fax
Email
shghiyas@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Nursing and Midwifery, Tehran
Full name of responsible person
Mahnaz Antikchi
Position
Master of Nursing Student
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery, Tohid square
City
Tehran
Postal code
1419733171
Phone
+98 35 1526 7077
Fax
Email
m_anticchi@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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