Effects of syrup of Debs (Grape product) on cancer-related fatigue in breast cancer patients: A randomised control trial
Design
Two arm parallel group randomized clinical trial, Double-blinded
Settings and conduct
60 breast cancer patients 18 to 70-year-old that are undergoing chemotherapy will enter the study.
Based on entry criteria, they will be entered in the study. Patients will be divided into two groups by simple random method. Group (A) will receive drug (Debs Syrup), Group (B) will receive placebo (placebo Syrup).
The dose of the drug will be given 3 cc three times a day and follow-up at weeks 0 and 4 and second week we will have telephones follow up
Participants/Inclusion and exclusion criteria
Patients women with cancer
Having at least 18 years and maximum 80 years
Having symptoms of fatigue
Having at least 8 g/dl Hemoglobin
Having at least 30% Hematocrit
Having at least 2mg/dl Billy Rubin
Having at least 2mg/dl Creatinine
Having normal TSH
Intervention groups
There are two intervention groups in this study, one group gets a Debs Syrup, and the other group receives the placebo Syrup.
Main outcome variables
Chemotherapy Induced Fatigue score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190708044149N1
Registration date:2020-01-28, 1398/11/08
Registration timing:registered_while_recruiting
Last update:2020-01-28, 1398/11/08
Update count:0
Registration date
2020-01-28, 1398/11/08
Registrant information
Name
Reyhaneh Gharehgozlou
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 3521
Email address
reyhangh792@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-30, 1398/04/09
Expected recruitment end date
2020-02-28, 1398/12/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of syrup of Debs (Grape product) on breast cancer-related fatigue in breast cancer patients: A randomised control trial
Public title
Effects of syrup of Debs on fatigue in breast cancer patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients women with Breast cancer
Having at least 18 years and maximum 80 years
Having symptoms of fatigue
Having at least 8 g/dl Hemoglobin
Having at least 30% Hematocrit
Having at least 2mg/dl Billy Rubin
Having at least 2mg/dl Creatinine
Having normal TSH
Exclusion criteria:
Severe Hb drop during study
Severe Platelets and white blood cell loss during the study
change of treatment
Age
From 18 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization: The numbers from 1 to 60 is written on 60 papers and placed inside a bag. Each time a patient enters the study according to entry criteria, a paper is removed from the bag and the number that is written on the paper will be the number of intervention medication.
Blinding (investigator's opinion)
Double blinded
Blinding description
Drug and placebo are coded, patient and researcher are blind
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
2019-06-29, 1398/04/08
Ethics committee reference number
IR.SBMU.CRC.REC.1398.002
Health conditions studied
1
Description of health condition studied
Fatigue related breast cancer
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Fatigue severity score based on fatigue eye scale criterion
Timepoint
Zero and 4 weeks after treatment
Method of measurement
Fatigue Eye Scale Criterion Questionnaire
2
Description
Fatigue severity score
Timepoint
Zero and 4 weeks after treatment
Method of measurement
Fatigue severity scale questionnaire
3
Description
Cancer Fatigue Scale Score
Timepoint
Zero and 4 weeks after treatment
Method of measurement
Cancer Fatigue Scale Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Fatigue patients with breast cancer receiving 10 cc syrup three times daily for four weeks
Category
Treatment - Drugs
2
Description
Control group: Fatigue patients with breast cancer receiving 10 cc placebo three times daily for four weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Tajrish Hospital
Full name of responsible person
Dr. Ghazaleh Heydarirad
Street address
Shahrdari st, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
Pr_shohada@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr.Somayeh Esmaeili
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 3521
Email
sesmaeili@sbmu.ac.ir
Grant name
Research Assistant of Shahid Beheshti University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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 3521
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 3521
Email
ghazalrad@yahoo.com
Person responsible for updating data
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
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
ghazalrad@yahoo.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