The aim of this study is Effect of herbal marine compound (HESE-A) on Quality of life in women with breast cancer
Inclusion criteria: age above 18 years and below 60 years, diagnosis of breast cancer by oncologist and pathologist physician,History of at least one course of chemotherapy
Exclusion criteria: Forgot pills Hesa - A for five consecutive times or more,Use of medication or other treatment methods to reduce the effects of other common medications prescribed by the doctor
Single-blind, controlled study randomized clinical trial of chemotherapy at the center of the city of Bushehr on 72 women with breast cancer undergoing chemotherapy will be done. After selecting 72 female patients with breast cancer among all patients, 36 patients were divided into two groups: the intervention group (drug Hsa-A) and control group (placebo) will be. The intervention and control groups after chemotherapy treatments ، Hesa-a daily one tablet orally (50 mg) will start and lasts for three months and the control group patients received placebo capsules daily Through oral . Quality of life in patients before the intervention, 45 and 90 days after treatment is assessed via questionnaire
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015112322466N8
Registration date:2016-01-31, 1394/11/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-01-31, 1394/11/11
Registrant information
Name
Shahnaz Pouladi
Name of organization / entity
Bushehr University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 917 374 0061
Email address
sh.pooladi@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Bushehr University of Medical Sciences
Expected recruitment start date
2016-01-30, 1394/11/10
Expected recruitment end date
2016-07-31, 1395/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of herbal marine compound (HESE-A) on Quality of life in women with breast cancer in medical centers in Bushehr city in 1394
Public title
Effect of herbal marine compound (HESE-A) on Quality of life in women with breast cancer in medical centers in Bushehr city in 1394
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age above 18 years and below 60 years, diagnosis of breast cancer oncologist and pathologist doctor (stage 3 and 4); history of at least one course of chemotherapy, no history of drug allergy Hsa-A
Exclusion criteria from the study include: Forgot pills Hesa - A for five consecutive times or more, the use of drugs or other treatment methods to reduce the effects of other common medications prescribed by your doctor; the risk of problems and severe gastrointestinal side effects during the study, and eventually the desire to continue to participate in the study.
Age
From 18 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Bushehr University of Medical Sciences
Street address
Bushehr University of Medical Sciences, Bushehr Iran
City
Bushehr
Postal code
Approval date
2015-11-14, 1394/08/23
Ethics committee reference number
bpums.res.1394.23
Health conditions studied
1
Description of health condition studied
breast cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
Quality of Life
Timepoint
Before the study, 45 days and 90 days after treatment
Method of measurement
questionnaire
Secondary outcomes
1
Description
Quality of Life
Timepoint
Before the study, 45 days and 90 days after treatment
Method of measurement
questionnaire
Intervention groups
1
Description
The control group received placebo capsules (identical in shape Hesa-a capsules) One capsule (50 mg) daily through orally for three months
Category
Placebo
2
Description
In the intervention group after a course of chemotherapy (second or more) on a daily basis Hesa-a orally one tablet (50 mg) will start for three months