A comparative study of the effect of Venlafaxine and Oxybutynin in controlling Hot Flash attacks in Patients with Breast cancer.
Design
Randomized Clinical trial with two groups of parallel intervention, double-blind, , phase 2, on 64 patients
Settings and conduct
In this study, Premenopausal patients with Breast cancer referred to Omid Hospital in Isfahan with complaints of Hot Flashes were randomly divided into two groups: receiving Venlafaxine 37.5 mg tablets daily or receiving 10 mg oxybutynin tablets daily for 8 weeks. They will be visited Before the intervention and the severity of the Hot Flashes will be assessed and recorded.Accordingly, feeling warmness without sweating (score 1), feeling warmness with sweating so that the patient is able to continue daily activities (score 2), feeling sever warmness with sweating so that the patient is not able to continue normal activities (score 3). Hot Flashes that wake the patient up(score 4). After eight weeks of medication, patients will be re-evaluated and the severity of the attacks will be re-evaluated and compared between the two groups. In this study, participating patients, principal researcher and statistical analyst will not know how participants are placed in intervention groups.
Participants/Inclusion and exclusion criteria
Pre-menopausal patients with Breast cancer complaining of Hot Flashes
Intervention groups
Intervention group 1: Patients in this group will receive one venlafaxine 37.5 mg tablet daily.
Intervention group 2: Patients in this group will receive one 10 mg oxybutynin tablet daily.
Main outcome variables
Severity of Hot Flashes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210822052256N1
Registration date:2021-10-27, 1400/08/05
Registration timing:prospective
Last update:2021-10-27, 1400/08/05
Update count:0
Registration date
2021-10-27, 1400/08/05
Registrant information
Name
Ali Akhavan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3235 0210
Email address
aliakhavan@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-11, 1400/08/20
Expected recruitment end date
2022-03-11, 1400/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effect of Venlafaxine and Oxybutynin in controlling Hot Flashes in patients with Breast Cancer
Public title
Comparison of the effect of Venlafaxine and Oxybutynin in the Treatment of Hot Flashes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18 years or older
Pre-menopause
At least 6 months have passed since the last Menstrual Period.
Hot Flashes attacks
Willingness to participate in the study
Exclusion criteria:
Uncontrolled Hypertension
Chronic Heart Failure
Chronic Kidney Disease
Chronic Lung Failure
Chronic Liver Failure
Pregnancy
Breast feeding
Taking Anti Depressant Drugs
Taking other Medications to control Hot Flashes over the past Two weeks
Age
From 18 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Patients participating in the study will be divided into two groups getting Oxybutynin or Venlafaxine; using a Random Number Table.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants in this study will be divided into two groups receiving oxybutynin or venlafaxine, and patients in each group will receive one tablet per day, which will be in the same container and without the name and specifications of the Drug, without knowing the type of Drug. Participants in the study, the Main Researcher, the Clinical Evaluator and the Statistical analyst of the study will not know how patients are placed in the groups receiving Venlafaxine or Oxybutynin.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Medicine-Isfahan University of Medical Sciences
Street address
Hezar jarib Ave, Isfahan University of Medical Sciense
City
Isfahan
Province
Isfehan
Postal code
8184917911
Approval date
2021-09-10, 1400/06/19
Ethics committee reference number
IR.MUI.MED.REC.1400.466
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
Severity of Hot Flashes
Timepoint
At the beginning of the study and 8 weeks after taking Venlafaxine or Oxybutynin
Method of measurement
Check List
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Venlafaxine 37.5 mg tablets one tablet per day for 8 weeks Product of Loghman Pharmaceutical Company
Category
Treatment - Drugs
2
Description
Intervention group: Oxybutynin 10 mg tablets, one tablet per day for 8 weeks, produced by Exir Pharmaceutical Company
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Omid Hospital
Full name of responsible person
Ali Akhavan
Street address
Motahari Ave., Omid Hospital
City
Isfahan
Province
Isfehan
Postal code
8184917911
Phone
+98 31 3235 0214
Email
aliakhavan@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooy Javanmard
Street address
Hezar Jarib Ave., Isfahan University of Medical Sciense
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?