Objective: Evaluation the effect of bupropion on cancer-related fatigue. Design: Randomized, double-blind, placebo controlled clinical trial. Setting: Patients with heterogenous type of cancer and diagnosed cancer-related fatigue in Seyed-Al-Shohada Clinic affiliated to Isfahan University of Medical Sciences. Major Inclusion and Exclusion criteria: Patients at least 18 years old, having a diagnosis of cancer with survival expectancy greater than 6 months, having a cancer-related fatigue defined by a score 4 or more on a brief fatigue inventory (BFI) screening scale and hemoglobin more than 9 g/dl taken less than 4 weeks before enrollment. Patients with Karnofsky Performance Scale of <50, history of convulsive seizure, current use (within 6 weeks preceding participation) of erythropoietin, psychostimulants or antidepressants, brain metastasis, history of fatigue prior to cancer diagnosis, any medical cause for fatigue identified on screening tests or a review of systems, hypersensitivity to bupropion and illiteracy will be excluded. Intervention: Eligible patients will be randomized to drug and placebo groups. Patients in drug group will be received bupropion sustained release (SR) 150 mg/day for 4 weeks. Main outcome measures: The primary outcome measure is the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) to evaluate efficacy of bupropion SR at improving fatigue symptoms.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201706191497N7
Registration date:2017-06-26, 1396/04/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-26, 1396/04/05
Registrant information
Name
Sarah Mousavi
Name of organization / entity
Clinical Pharmacy Department, Pharmacy Faculty, Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 2567
Email address
smousavi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research,Isfahan University of Medical Sciences
Expected recruitment start date
2015-01-01, 1393/10/11
Expected recruitment end date
2017-08-01, 1396/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomized, placebo controlled, double blind clinical trial of the effect of bupropion on cancer-related fatigue
Public title
Evaluation of bupropion effects on cancer related fatigue in patients with cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria were at least 18 years old, having a diagnosis of cancer with survival expectancy greater than 6 months, having a cancer-related fatigue defined by a score 4 or more on a brief fatigue inventory (BFI) screening scale that ranged from 0 (none) to 10 (as bad as it can be), and hemoglobin more than 9 g/dl taken less than 4 weeks before enrollment.
The exclusion criteria were Karnofsky Performance Scale of <50, history of convulsive seizure, current use (within 6 weeks preceding participation) of erythropoietin, psycho stimulants or antidepressants, brain metastasis, history of fatigue prior to cancer diagnosis, any medical cause for fatigue identified on screening tests or a review of systems, hypersensitivity to bupropion and illiteracy.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, P.O. Box 319, Hezar-Jerib Ave., Isfahan, IR Iran, 81746 73461
City
Isfahan
Postal code
81746 73461
Approval date
2014-10-31, 1393/08/09
Ethics committee reference number
3515/9/د
Health conditions studied
1
Description of health condition studied
Cancer
ICD-10 code
C00-C97
ICD-10 code description
Malignant neoplasms
Primary outcomes
1
Description
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
Timepoint
Before intervention and after 4 weeks
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Quality of life
Timepoint
Before intervention and after 4 weeks
Method of measurement
Questionnaire
Intervention groups
1
Description
Patients in intervention group will be received bupropion sustained release (SR) (Abidi pharmaceutical, Tehran, Iran) 150 mg/day for 4 weeks.
Category
Treatment - Drugs
2
Description
Patients in control group will be received placebo of bupropion sustained release (SR) (Abidi pharmaceutical, Tehran, Iran) 150 mg/day for 4 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Seyed-Al-Shohada Hospital
Full name of responsible person
Sarah Mousavi
Street address
Hezar Jerib avenue, Isfahan University of Medical Sciences, Seyed-Al-Shohada Hospital
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research,Isfahan University of Medical Sciences
Full name of responsible person
Dr Mehdi Nematbakhsh
Street address
Hezar Jerib avenue, Isfahan University of Medical Sciences, Isfahan
City
Isfahan
Grant name
1347/9/12/پ
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research,Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Dr Sarah Mousavi
Position
Assistant professor
Other areas of specialty/work
Street address
Hezar Jerib avenue,Isfahan University of Medical Sciences, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3792 7072
Fax
Email
s.mousavi@pharm.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Sarah Mousavi
Position
PhD
Other areas of specialty/work
Street address
Hezar Jerib avenue,Isfahan University of Medical Sciences, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3792 7072
Fax
Email
s.mousavi@pharm.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Sarah Mousavi
Position
Assistant Professor
Other areas of specialty/work
Street address
Hezar Jerib avenue,Isfahan University of Medical Sciences, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3792 7072
Fax
Email
s.mousavi@pharm.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)