Treatment of fatigue in patients suffering from cancer more effectively
Design
Double blind placebo controlled clinical trial with a parallel group design of 30 patients, randomized based on the random number table, phase 3
Settings and conduct
The study will be done in Tuba Cinic of Mazandaran Univeristy of Medical Scienses.
Patients will be divided into two 15-individual groups of intervention and control and the interventions will be performed on both groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 18 and more; score of at least 4 based on BFI scale; fatigue with unknown reason for at least on week.
Exclusion criteria: age under 18; history of use of CNS stimulants and antidepressants; history of suicide; history of seizure; pregnancy and lactation
Intervention groups
Bupropion will be administrated 75 mg/day (first three days) and 150 mg/day (rest of the days) to the patients for six weeks.
Fatigue and depression will be evaluated based on corresponding criteria and scales.
All approaches will be performed for control group but placebo will be used instead of Bupropion.
Main outcome variables
Degree of fatigue, depression and anxiety, quality of life, performance status
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090613002027N12
Registration date:2018-06-01, 1397/03/11
Registration timing:registered_while_recruiting
Last update:2018-06-01, 1397/03/11
Update count:0
Registration date
2018-06-01, 1397/03/11
Registrant information
Name
Ebrahim Salehifar
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1311 6546
Email address
esalehifar@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-14, 1397/01/25
Expected recruitment end date
2018-09-21, 1397/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy and safety of bupropion in cancer-related fatigue, a randomized double blind placebo controlled clinical trial
Public title
Efficacy and safety of bupropion in cancer-related fatigue
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients suffering from cancer-related fatigue
Score of at least 4 based on BFI (Brief Fatigue Inventory) scale (0-10)
Fatigue with unknown reason for at least one week and more
Exclusion criteria:
Age under 18
History of use of the CNS stimulants and antidepressants
History of seizure
History of use of erythropoietin in the last six weeks.
History of suicide
Use of MAOIs (Mono Amino Oxidase Inhibitors) in the last two weeks
Liver and renal failure
Pregnancy and lactation
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will enter the trial randomly based on the random number table.
Blinding (investigator's opinion)
Double blinded
Blinding description
participants, principle investigator, healthcare providers, data collectors and outcome assessors
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mazandaran University of Medical Scienses Ethical Committee
Street address
Mazandaran University of Medical Scienses, kilometer 18 of Farah Abad road, Sari, Iran
City
Sari
Province
Chahar-Mahal-va-Bakhtiari
Postal code
861-48175
Approval date
2017-09-20, 1396/06/29
Ethics committee reference number
IR.MAZUMS.REC.1396.3144
Health conditions studied
1
Description of health condition studied
Cancer related fatigue
ICD-10 code
Y43.3
ICD-10 code description
Drugs, medicaments and biological substances causing adverse effects in therapeutic use
Primary outcomes
1
Description
Fatigue score based on BFI scale
Timepoint
Before intervention and 2 and 6 weeks after intervention
Method of measurement
BFI questionnaire
2
Description
Fatigue score based on Functional Assessment of Chronic Illness Therapy (FACIT)
Timepoint
Before intervention and 2 and 6 weeks after intervention
Method of measurement
FACIT questionnaire
3
Description
Degree of depression an anxiety based on Hospital Anxiety and Depression scale (HADS)
Timepoint
Before intervention and 2 and 6 weeks after intervention
Method of measurement
HADS questionnaire
Secondary outcomes
1
Description
Performance status based on Eastern Cooperative Oncology Group (ECOG)
Timepoint
Before intervention and 2 and 6 weeks after intervention
Method of measurement
ECOG questionnaire
2
Description
Performance status based on Karnofsky Performance Status Scale
Timepoint
Before intervention and 2 and 6 weeks after intervention
Method of measurement
Karnofsky questionnaire
3
Description
Patient's quality of life based on European Organisation for Research and Treatment of Cancer QLQ-C30
Timepoint
Before intervention and 2 and 6 weeks after intervention
Method of measurement
EORTC QLQ-C30 questionnaire
Intervention groups
1
Description
Intervention group: administration of bupropion (made by Abidi pharmaceuticals) 75 mg once a day (for three days) then 75 mg twice a day till the end of study (six weeks)
Category
Treatment - Other
2
Description
Control group: administration of placebo once a day for the first three days then twice a day till the end of study
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tuba Cinic of Mazandaran Univeristy of Medical Scienses
Full name of responsible person
Ebrahim Salehifar
Street address
Tuba Clinic, Khazar Square, Sari
City
Sari
Province
Mazandaran
Postal code
861-48175
Phone
+98 11 3354 3241
Email
salehifare@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Scienses
Full name of responsible person
Dr Majid Saeedi
Street address
Research Deputy, Mazandaran university of medical Sciences, Moallem Square, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
861-48175
Phone
+98 11 3354 3241
Email
Esalehifar@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Mazandaran University of Medical Scienses
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
Department of Clinical Pharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences
Full name of responsible person
Ebrahim Salehifar
Position
Professor of Clinical Pharmacy
Latest degree
Ph.D.
Other areas of specialty/work
Clinical Pharmacist
Street address
School of Pharmacy of Mazandaran University of Medical Sciences, Payambar azam University Complex, Farah Abad road, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
861-48175
Phone
+98 11 3354 3241
Email
salehifare@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Clinical Pharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences
Full name of responsible person
Ebrahim Salehifar
Position
Professor of clinical pharmacy
Latest degree
Ph.D.
Other areas of specialty/work
clinical pharmacist
Street address
School of Pharmacy of Mazandaran University of Medical Sciences, Payambar azam University Complex, Farah Abad road, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
861-48175
Phone
+98 11 3354 3241
Email
salehifare@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Department of Clinical Pharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences
Full name of responsible person
Ebrahim Salehifar
Position
Professor of Clinical Pharmacy
Latest degree
Ph.D.
Other areas of specialty/work
Clinical Pharmacist
Street address
School of Pharmacy of Mazandaran University of Medical Sciences, Payambar azam University Complex, Farah Abad road, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
861-48175
Phone
+98 11 3354 3241
Email
salehifare@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available