Determination of the effect of syrup of Jollab on the fatigue of patients with breast cancer
Design
Two arm parallel group randomised clinical trial, triple blinded
Settings and conduct
Design of the study: Women patients with breast cancer referring to Shohaday-e- Tajrish Hospital of Tehran who have symptoms of cancer-related fatigue. In order to blind the investigator, medications are named as "A" for syrup of Jollab and B for placebo. The patient don't aware of the type of drug she is assigned to. In addition, the groups are entered into statistical analysis as "A" and "B
Participants/Inclusion and exclusion criteria
Inclusion criteria: women suffer from breast cancer-related fatigue; 1.Age between 18- 70 years old; 2. Hemoglobin level is at least 8g/dl; 3. Hematocrit level at least 30%; 4. normal TSH. Exclusion criteria: 1. Heart disease with unstable conditions; 2. Disabling Pulmonary Disease and History of Asthma; 3. Severe kidney disease; 4. Creatinine level greater than 2mg/dl; 5. Proteinuria; 6. The SGOT level more than 3 times of the normal threshold; 7. Bilirubin levels greater than 2mg/dl; 8. Positive history of hypersensitivity to saffron, rose water and honey; 9. severe infection; 10. Systemic disease;11. Positive history of gout or high level of uric acid; 12. An individual who uses antidepressants due to depression; 13. Simultaneous use of drugs that affect fatigue; 14. Uncontrolled pain; 15. Unwillingness to participate in the study.
Intervention groups
Group A: patients with breast cancer-related fatigue receiving syrup of Jollab, 10 cc three times daily; Group B: patients with breast cancer-related fatigue receiving placebo, 10 cc three times daily
Main outcome variables
The mean of score of "Visual Analogue Fatigue Scale", 2. The mean of score of "Fatigue Severity Scale", 3. The mean of score of "The Cancer Fatigue Scale"
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150825023753N8
Registration date:2018-06-05, 1397/03/15
Registration timing:retrospective
Last update:2018-06-05, 1397/03/15
Update count:0
Registration date
2018-06-05, 1397/03/15
Registrant information
Name
Mohammad Mahdi Parvizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3212 5592
Email address
parvizim@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-11-01, 1396/08/10
Expected recruitment end date
2018-05-20, 1397/02/30
Actual recruitment start date
2017-11-01, 1396/08/10
Actual recruitment end date
2018-05-20, 1397/02/30
Trial completion date
empty
Scientific title
Study of the effect of syrup of Jollab on cancer-related fatigue in patients with breast cancer: A randomised control trial
Public title
Effects of syrup of Jollab on fatigue in patients with breast cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Female gender
Age between 18- 70 years old
Patients known case of breast cancer
Hemoglobin level is at least 8 g / dl
Hematocrit level at least 30%
The level of TSH is normal
Exclusion criteria:
Patients known case of heart disease with unstable conditions
Disabling Pulmonary Disease and History of Asthma
Patients known case of severe kidney disease
Creatinine level is greater than 2mg / dl
Proteinuria
The SGOT level is more than 3 times of the normal threshold
Bilirubin levels is greater than 2mg / dl
Positive history of hypersensitivity to saffron, Rose water and Honey
Uncontrolled pain, severe infection, serious illness
Positive history of gout or high level of uric acid
An individual who uses antidepressants due to depression
Simultaneous use of drugs that affect fatigue
Unwillingness to participate in the study
Active treatment for anemia (transfusion or Epoetin Alfa Injection)
Age
From 18 years old to 70 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation software Ink was used to create a randomization table
Blinding (investigator's opinion)
Triple blinded
Blinding description
In order to blind the investigator, medications were named A (syrup of Jollab ) and B (Placebo). The patient was not aware of the type of drug he was assigned to. The groups were also coded A and B to the statistical analyzer.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee on Biomedical Research of Shahid Beheshti University of Medical sciences
Street address
Shahid Beheshti University of Medical sciences, Daneshju Blv.
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2017-10-29, 1396/08/07
Ethics committee reference number
IR.SBMU.REC.1396.525
Health conditions studied
1
Description of health condition studied
Neoplastic (malignant) related fatigue
ICD-10 code
R53.0
ICD-10 code description
Neoplastic (malignant) related fatigue
Primary outcomes
1
Description
Score of Fatigue Severity "Visual Analogue Fatigue Scale"
Timepoint
The weeks of 0 and 4 after treatment
Method of measurement
Using Visual Analogue Fatigue Scale questionnaire
2
Description
Score of "Fatigue Severity"
Timepoint
The weeks of 0 and 4 after treatment
Method of measurement
Fatigue Severity Scale questionnaire
3
Description
Score of "The Cancer Fatigue Scale"
Timepoint
The weeks of 0 and 4 after treatment
Method of measurement
The Cancer Fatigue Scale questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patients with breast cancer-related fatigue receiving syrup of Jollab, 10 cc three times daily for four weeks;
Category
Treatment - Drugs
2
Description
Control group: patients with breast cancer-related fatigue receiving placebo, 10 cc three times daily for four weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohay-e-Tahrish Hospital
Full name of responsible person
Dr. Ghazaleh Heydarirad
Street address
Tajrish Square, Shohaday-e-Tejarish Hospital
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 9201
Email
ghazalrad@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Ghazaleh Heydarirad
Street address
Shams Alley, Vali-e-Asr Street, Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 6027
Email
ghazalrad@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Ghazaleh Heydarirad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Shams Alley, Vali-e-Asr Street, Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 6027
Email
ghazalrad@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Ghazaleh Heydarirad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Shams Alley, Vali-e-Asr Street, Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 6027
Email
ghazalrad@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Mahdi Parvizi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3235 1087
Email
mmparvizi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Demographic data and the result of the clinical trial
When the data will become available and for how long
6 month later
To whom data/document is available
Researchers
Under which criteria data/document could be used
After publication of the extracted article of the clinical trial
From where data/document is obtainable
Sending Email to the researchers
What processes are involved for a request to access data/document