Purpose: Detarmination of relationship between Aspirin use and reduction of breast cancer recurrence rate in patients referred to Breast Cancer Prevention Clinic, 1390
Design study: Randomized, not blinded, not used placebo, single-center, phase 2 or 3 clinical trial
Methods: Considering the α=0.5 & β=0.8 and ten percent expect to reduce recurrence of breast cancer in the intervention group and also patients under consideration for two years, the sample size is 400 (200 in each group). Breast cancer patients in Stage 1 , 2 and 3 who surgical and adjuvant treatments have been completed and referred to Breast Cancer Prevention Clinic are randomly divided into two groups and is given a 80-mg Aspirin tablets for one group daily and is not given any placebo to other group. Patients who experience gastrointestinal problems and are sensitive to Aspirin are excluded. Patients are followed for two years and are checked in terms of local recurrence & metastasis and patients with each stage are compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202218215N1
Registration date:2012-02-21, 1390/12/02
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-02-21, 1390/12/02
Registrant information
Name
Sedigheh Tahmasebi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1234 9334
Email address
tahmasebis@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2012-03-19, 1390/12/29
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Relationship between Aspirin use and reduction of breast cancer recurrence rate in patients referred to Breast Cancer Prevention Clinic, 1390
Public title
The effect of Aspirin on breast cancer recurrence
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Breast cancer patients in stage 1 , 2 and 3 and surgical and adjuvant treatments have been completed;
Exclusion criteria: Patients who experience gastrointestinal problems and are sensitive to Aspirin are excluded.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
400
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
1
Registry name
no
Secondary trial Id
no
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Karim Khan Zand street, Shiraz
City
Shiraz
Postal code
1978-71345
Approval date
2011-11-24, 1390/09/03
Ethics committee reference number
CT-90-5822
Health conditions studied
1
Description of health condition studied
Breast cancer
ICD-10 code
C50.0 , C5
ICD-10 code description
Nipple and areola, Central portion of breast, Upper-inner quadrant of breast, Lower-inner quadrant of breast, Upper-outer quadrant of breast, Lower-outer quadrant of breast, Axillary tail of breast, Overlapping lesion of breast, Breast, unspecified
Primary outcomes
1
Description
Clinical examination
Timepoint
2 years
Method of measurement
Clinical examination
Secondary outcomes
1
Description
Mammography
Timepoint
2 years
Method of measurement
Mammography
Intervention groups
1
Description
Interventional groups: 200 patients with breast cancer in stage 1 , 2 and 3 is finished surgery and adjuvant therapy, randomly selected and a Aspirin 80 mg is administered daily. Patients are followed two years, and are checked in terms of local recurrence & metastasis and patients with each stage are compared.
Category
Treatment - Drugs
2
Description
Control group: 200 patients with breast cancer in stage 1 , 2 and 3 is finished surgery and adjuvant therapy, randomly selected and is not given any placebo. Patients are followed two years, and are checked in terms of local recurrence & metastasis and patients with each stage are compared.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Breast Clinic of Motahari
Full name of responsible person
Sedigheh Tahmasebi
Street address
Namazi square
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 Mohammad Hossein Dabbagh Manesh
Street address
Karim Khan Zand street, Shiraz
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
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
Shiraz University of Medical Sciences
Full name of responsible person
Sedigheh Tahmasebi
Position
General surgeon,Assistant Professor of Shiraz University of Medical Sciences
Other areas of specialty/work
Street address
Karim Khan Zand street, Shiraz
City
Shiraz
Postal code
1978-71345
Phone
+98 71 1230 5410
Fax
Email
tahmasebis@sums.ac.ir
Web page address
www.sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sedigheh Tahmasebi
Position
General surgeon
Other areas of specialty/work
Street address
Karim Khan Zand street, Shiraz
City
Shiraz
Postal code
1978-71345
Phone
+98 71 1230 5410
Fax
Email
tahmasebis@sums.ac.ir
Web page address
www.sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sedigheh Tahmasebi
Position
General surgeon,Assistant Professor of Shiraz University of Medical Sciences
Other areas of specialty/work
Street address
Karim Khan Zand street, Shiraz
City
Shiraz
Postal code
1978-71345
Phone
+98 71 15410
Fax
Email
Web page address
www.sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)