The effect of omega- 3 on quality of life,menopausal sumptoms and sextual dysfunction in tamoxifen consumer women with breast cancer that refer to motahhari breast cancer clinic in 1390
The aim of this study,was to omega-3 effect on quality of life, menopausal symptoms and sexual dysfunction in women taking tamoxifen that had breast cancer. Samples in this study were 140 women with breast cancer complained of the side effects of tamoxifen that after completing the questionnaire were entering the study and And were divided into two groups. Omega-3 group and the placebo group that received a questionnaire before and after completing a period of three months and then were compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201104052515N3
Registration date:2012-08-09, 1391/05/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-08-09, 1391/05/19
Registrant information
Name
Maasumeh Kaviani
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4251
Email address
kavianm@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellory for reaserch of shiraz university of medical sciences
Expected recruitment start date
2011-11-19, 1390/08/28
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of omega- 3 on quality of life,menopausal sumptoms and sextual dysfunction in tamoxifen consumer women with breast cancer that refer to motahhari breast cancer clinic in 1390
Public title
The effect of omega-3 on the side effects of tamoxifen in women with breast cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Medical record review identified female patients who were initially diagnosed as stage 1 and 2 with breast cancer prior to menopause age or menopause are not related to medication or surgery, married, be literate, signed and confirmed consent form, completed adjuvant treatment such as chemotherapy, hormonal therapy with tamoxifen or suffered by tamoxifen treatment side effects such as; hot flashes, sexual dysfunction, night sweats, negative impact on life quality, that met the inclusion criteria.
After deletion of patients who met specific exclusion criteria such as; high blood pressure, blood lipids, renal and thyroid dysfunction, history of allergy to Ω-3, using medication or food complementary for the purpose of preventing or reducing complications and/or side effects of tamoxifen treatment, using medication to treat mental disorder, having sever and progressive disease(s), disease relapsation, those patients who were initially or latelly diagnosed with advanced stages (>2) of breast cancer and finally those one unwillingness to continue participation in research.
Age
To 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
140
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
Shiraz University of Medical Sciences and Health Services
Street address
Shiraz- Namazi Square- Fatemia School of Nursing Midwifery
City
Shiraz
Postal code
Approval date
2011-10-24, 1390/08/02
Ethics committee reference number
CT-90_5786
Health conditions studied
1
Description of health condition studied
Quqlity of life, side effect of menopauses,sexual dysfunction
ICD-10 code
-
ICD-10 code description
-
Primary outcomes
1
Description
Hot flashes
Timepoint
befor intervention and three months after intervention
Method of measurement
part of the grin questionnaire
2
Description
Night sweats
Timepoint
before intervention and Three months after intervention
Method of measurement
part of the grin questionnaire
3
Description
Quality of life
Timepoint
befor intervention and three months after intervention
Method of measurement
QLQ-C30 questionnaire
4
Description
Sexual dysfunction
Timepoint
before intervention and three months after intervention
Method of measurement
FSFI questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
omega-3 1000 mg capsule one times a day for three months
Category
Prevention
2
Description
omega-3 1000 mg capsule one time a day for three months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahhari Breast clinic
Full name of responsible person
Rezvan Heidari
Street address
Shiraz- Namazi square- Motahhari breast clinic
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, shiraz university of medical science
Full name of responsible person
Mr. Kambiz Skandari
Street address
Shiraz- Namazi Square- Building university of Medical Science
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 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
shiraz university o medical science
Full name of responsible person
Maasumeh Kaviani
Position
MD of midwifery
Other areas of specialty/work
Street address
Shiraz- Fatemia School of Nursing and Midwufery
City
shiraz
Postal code
Phone
+98 71 1212 4012
Fax
Email
kavianm@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University Of Medical Science
Full name of responsible person
Maasumeh Kaviani
Position
MD of midwifery
Other areas of specialty/work
Street address
Shiraz- Namazi Square- Fatemia School Of Nursing and Midwifery
City
Shiraz
Postal code
Phone
+98 71 1647 4252
Fax
Email
kavianm@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)