The effect of Chicory-Fumitory syrup in comparison with megestrol in hot flashes caused by androgen deprivation therapy in prostate cancer patients referred to cancer clinic of Labafinejad hospital in 2019-20.
Design
Clinical trial, Randomized, Comparison between traditional medicine product and conventional intervention
Settings and conduct
Method:
firstly, we will evaluate the number and severity of hot flashes in first week of study as baseline and then, we will evaluate the number and severity of hot flashes in 4 weeks of intervention in two groups.
Place of intervention: oncology clinic of Labbafinejad hospital, Tehran, Iran.
Participants/Inclusion and exclusion criteria
The inclusion criteria of this trial are listed below:
1.Age above 18
2.To have prostate cancer
3.To be under androgen deprivation therapy and complaining of hot flashes
Non-entry criteria are listed below:
1.Not having patient inform consent
2.Being under or about to chemotherapy/radiotherapy and surgery
3.Starting ADT <4 weeks before trial and alteration in ADT plan within 8 weeks after trial.
4.Number of hot flashes <2 per day and <14 in a week.
5.Complaing of hot flashes < 2 weeks before trial
6.Taking anti depressant drug during 4 last weeks (e.g. SSRIs)
7.Survival less than 6 months
8.Metastatic cancer
9.To have advanced kidney and liver diseases
10.To have coagulation and vascular disorders
Intervention groups
1.First group: those who get Chicory-Fumitory syrup
2.Second group: those who get Megetrol
Main outcome variables
Number of hot flashes, Severity of hot flashes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190112042333N1
Registration date:2019-01-26, 1397/11/06
Registration timing:registered_while_recruiting
Last update:2019-01-26, 1397/11/06
Update count:0
Registration date
2019-01-26, 1397/11/06
Registrant information
Name
Sajjad Sadeghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 3521
Email address
drsadeghi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-07-23, 1398/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Chicory-Fumitory Syrup and megestrol in hot flashes in prostate cancer patients
Public title
The effect of Chicory-Fumitory Syrup and megestrol in hot flashes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age above 18
To be a prostate cancer patient
To be under ADT therapy and complaining hot flashes
Exclusion criteria:
Metastatic Cancer
Liver or kidney disorders
Being under treatment for hot flashes
Age
From 18 years old
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization is done by Randomizer software, before starting the trial. Patients who have inclusion criteria, are randomly assigned into one of the two groups: syrup or Megestrol tablet.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical commitee of Shahid Beheshti University of Medical Sciences
The number of hot flashes: average of frequency during a week according to based on Daily Diary of Hot flashes.
Timepoint
Daily
Method of measurement
Calculation the average of frequency of hot flashes in a week
2
Description
Severity of hot flashes: average of severity during a week according to based on Daily Diary of Hot flashes.
Timepoint
Daily
Method of measurement
Calculation the average of severity scores of hot flashes in a week
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group (1): Chicory and Fumitory Syrup contains hydro alcoholic extracts of Chicory and Fumitory with dosage of 7 mil/ daily divided to 2 doses.
Category
Treatment - Drugs
2
Description
Intervention group (2): Megestrol tablet, 20 milligram 2 times daily
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Oncology clinic of Labbafinejad hospital
Full name of responsible person
Sajjad Sadeghi
Street address
No.8 Shams Alley, Vali-e-Asr Street
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
drsadeghi@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
info@sbmu.ac.ir
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
Sajjad Sadeghi
Position
MD, PhD Candidate
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No.8 Shams Alley, Vali-e-Asr Street
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
drsadeghi@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sajjad Sadeghi
Position
MD, PhD Candidate
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No.8 Shams Alley, Vali-e-Asr Street
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
drsadeghi@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Tehran
Position
MD, PhD Candidate
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No.8 Shams Alley, Vali-e-Asr Street
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
drsadeghi@sbmu.ac.ir
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Publishing results in form of a PhD thesis and an article indexing in ISI
When the data will become available and for how long
after PhD thesis defence
To whom data/document is available
Public
Under which criteria data/document could be used
for research reasons
From where data/document is obtainable
Shahid Beheshti University of Medical Sciences
What processes are involved for a request to access data/document