Protocol summary

Summary
The study aims to compare the quality of life of the patients with solid cancer before and after treatment with fluoxetine and placebo. In this randomized, double-blind clinical trial, 150 patients with solid cancer referring to the hematology and oncology department of Imam Khomeini Hospital of Ardabil, Iran will enter the study. The main inclusion criteria include being over 15 years of age and lack of known psychological disorders. Exclusion criteria include lack of interest for participation, use of medications with depressive symptoms, being diagnosed with other psychiatric disorders. Patients will be given questionnaires containing personal information with two questions: 1) In the last month, have you had any feelings of disappointment or depression? 2) In the last month, have you had any feelings of lack of interest in doing your jobs? The answers will be ranked based on the scale of 0 to 4. Patients with scores of 5 or more will be entered into the next phase of the study. After the random selection of patients, Fluoxetine 20 mg and placebo will be prescribed orally to the intervention group and the control group, respectively, for 12 weeks. If side effects emerge, the medicine will be stopped and the patient will be excluded from the study. Before and after the intervention, the patients will answer a questionnaire of general health and quality of life. Based on the answers, the general health and quality of life status of the patients before and after the intervention will be compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015012220751N1
Registration date: 2015-02-18, 1393/11/29
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-02-18, 1393/11/29
Registrant information
Name
Behzad Mohammadi
Name of organization / entity
Ardabil University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 45 3335 3905
Email address
behzad.mohammadi@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
The Research Department of Ardabil University of Medical Sciences
Expected recruitment start date
2015-01-30, 1393/11/10
Expected recruitment end date
2015-03-01, 1393/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of fluoxetine and placebo in improving the quality of life in patients with solid cancers referred to Imam Khomeini Hospital of Ardabil (double blind study)
Public title
The effect of fluoxetine in improving the quality of life in patients with cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: an age of 15 years or over; a definitive diagnosis of cancer confirmed by a specialist; laps of a minimum of one year from the diagnosis of the cancer; the lack of a known psychological problems ; being a patient with a definitive diagnosis of solid cancer being treated by or prepared for chemotherapy; being out of an acute phase of the disease and within stable clinical conditions; voluntary decision for participation. Exclusion criteria: lack of interest for participation in the study; use of medications with depressive symptoms; presence of other psychiatric diagnoses.
Age
From 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ardabil University of Medical Sciences
Street address
Daneshgah Street, University of Medical Sciences,Ardabil,Iran
City
Ardabil
Postal code
Approval date
2013-11-30, 1392/09/09
Ethics committee reference number
Arums.REC.92.25

Health conditions studied

1

Description of health condition studied
cancer
ICD-10 code
c16
ICD-10 code description
Malignant neoplasm of stomach

Primary outcomes

1

Description
improving the quality of life
Timepoint
befor and after intervention
Method of measurement
SF-36 questionaire

2

Description
general health
Timepoint
before and after intervention
Method of measurement
general health questionaire

Secondary outcomes

empty

Intervention groups

1

Description
Control group : oral prescription of similar placebo daily for 12 weeks
Category
Treatment - Drugs

2

Description
Intervention group:oral prescription of fluoxetine capsules 20 mg daily for 12 weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Hematology and Oncology Department of Ardabil Emam Khomeini Hospital
Full name of responsible person
Behzad Mohammadi
Street address
City
Ardabil

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Shahram Habibzadeh
Street address
Daneshgah Street, University of Medical Sciences,Ardabil,Iran
City
Ardabil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Behzad Mohammadi
Position
Resident of Internal Medicine
Other areas of specialty/work
Street address
Imam Khomeini Hospital,Ardabil,Iran
City
Ardabil
Postal code
Phone
+98 45 3335 3905
Fax
Email
behzad.mohammadi.arums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Asgar Pirzadeh
Position
Hematology and Oncology Specialty
Other areas of specialty/work
Street address
Emam Khomeini Hospital,Ardabil,Iran
City
Ardabil
Postal code
Phone
+98 45 3325 1401
Fax
Email
asgar.pirzadeh@arums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Firouz Amani
Position
PHD of Biostatistics
Other areas of specialty/work
Street address
ِDaneshgah Street ,University of Medical Sciences,Ardabil,Iran
City
Ardabil
Postal code
Phone
+98 45 3351 3777
Fax
Email
f.amani@arums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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