Comparison the efficacy of fluoxetine, bupropion and methylphenidate on the improvement of cancer related fatigue
Design
Three arm parallel-group double-blinded randomized clinical trial on 60 patients. Stratified Block Random Allocation is used for randomization.
Settings and conduct
This study will be done in clinics affiliated to Shahrekord University of Medical Sciences and Ayatollah Kashani hospital from September 2020 to September 2021. Patients with cancer-related fatigue will be referred by an oncologist. After obtaining informed consent, they will be randomly assigned to 3 groups: fluoxetine, bupropion, and methylphenidate. The patient will be evaluated using the Cancer Fatigue scale, Fatigue Visual Analogue scale, and Quality of life score in the European Organization for Research and treatment of cancer quality of life questionnaire and before the intervention, on weeks 4 and 8.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Cancer patients suffering from fatigue; under chemotherapy; Patients who have not yet received an intervention (pharmacological or non-pharmacological) to treat cancer-related fatigue
Non-inclusion criteria: Leukemic patients; metastasis; Hb<10; respiratory or cardiac disease; balance problem; severe bone pain; past history of any major psychiatric disease
Intervention groups
Patients in the fluoxetine group will be prescribed fluoxetine 10 mg/d. During treatment, the dose increases to 40 mg per day, depending on the patient's tolerance. In the bupropion group, patients will receive 100 mg/d of bupropion. Depending on patients' tolerance it would be increased up to 300 mg/d. Patients in the methylphenidate group are given 10 mg of methylphenidate daily and can be increased to 30 mg per day depending on the patients' tolerance.
Main outcome variables
Fatigue score in Cancer Fatigue scale and Fatigue Visual Analogue scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180623040193N3
Registration date:2020-08-11, 1399/05/21
Registration timing:prospective
Last update:2020-08-11, 1399/05/21
Update count:0
Registration date
2020-08-11, 1399/05/21
Registrant information
Name
Elham Zarean
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3222 0016
Email address
e.zarean@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of bupropion, fluoxetine, and methylphenidate in improving cancer-related fatigue
Public title
Comparison of bupropion, fluoxetine, and methylphenidate in cancer-related fatigue
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Definite diagnosis of cancer from at least 2 month ago
Patients are undergoing outpatient chemotherapy
Lack of metastasis
Lack of any chronic cardiac or respiratory diseases or diabetes mellitus
Lack of severe bone pain and balance problem
Hemoglobin≥ 10
Ability to read and write
Not receiving any type of treatment (drug or psychotherapy) for fatigue in the past
Not having leukemia
Lack of past history of any major psychiatric illnesses for which patient was hospitalized or medicated
Exclusion criteria:
Acute respiratory, cardiac or infectious diseases
Hemoglobin<10
Uncontrolled hypothyroidism
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Given that the type of cancer may be a confounding factor, the samples are initially classified into three categories: breast cancer, gastrointestinal cancer, and other cancers. In each class, to assign samples to either the groups of fluoxetine, bupropion or methylphenidate, block randomization with a sample size of 6 is used. The sample assignment in each block is done using random allocation software.
Blinding (investigator's opinion)
Double blinded
Blinding description
To contemplate blindness, the researcher who allocated the patients had no role in the treatment and the investigating physician who was responsible for the treatment of the patients was not informed about the patients’ medication. Further the patients were not aware of the nature of the allocation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahrekord University of Medical Sciences
Street address
Kashani Ave, Shahrekord University of Medical Science
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Approval date
2020-03-14, 1398/12/24
Ethics committee reference number
IR.SKUMS.REC.1398.240
Health conditions studied
1
Description of health condition studied
Cancer-related fatigue
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Fatigue score in Cancer Fatigue scale and Fatigue Visual Analogue scale.
Timepoint
Before intervention, 1 month and 2 months after pharmacotherapy
Method of measurement
Cancer Fatigue scale, Fatigue Visual Analogue scale
Secondary outcomes
1
Description
The Quality of life score in European Organization for Research and treatment of cancer quality of life questionnaire
Timepoint
Before intervention, 1 month and 2 months after pharmacotherapy
Method of measurement
European Organization for Research and treatment of cancer quality of life questionnaire version 3
Intervention groups
1
Description
Intervention group: Fluoxetine 20 mg/d (Exir pharmaceutics, Iran) for the first 5 days then twice a day for the rest of the first month. In the second month, depending on the patient's tolerance, it could be increased to 40 mg/d.
Category
Treatment - Drugs
2
Description
Intervention group: Bupropion 100 mg/d (Exir pharmaceutics, Iran) with identical shape and color as fluoxetine capsules for the first five days, then twice a day for the rest of the first month. In the second month depending on the patient's tolerance, it could be increased to 300 mg/d.
Category
Treatment - Drugs
3
Description
Intervention group: Methylphenidate 10 mg/d (Poursina pharmaceutics, Iran) with identical shape and color as fluoxetine capsules for the first five days, then twice a day for the rest of the first month. In the second month depending on the patient's tolerance, it could be increased to 30 mg/d.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani Hospital
Full name of responsible person
Mosharaf Niloufar
Street address
Parastar Ave, Kashani Hosp
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۶۷۵۸۹۱۵
Phone
+98 38 3226 4825
Email
dr.ataee@ymail.com
2
Recruitment center
Name of recruitment center
Emam Ali Clinic
Full name of responsible person
Mosharaf Niloufar
Street address
Shariati Ave, Emam ali Clinic
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۶۷۵۸۹۱۵
Phone
+98 38 3225 3743
Email
dr.ataee@ymail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Mehraban Sadeghi
Street address
Kashani Ave, Shahre
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3334 2414
Email
pajoohesh@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Elham Zarean
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Parastar Ave, Hajar Hosp
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۶۸۵۴۶۳۳
Phone
+98 38 3222 0016
Email
ezarean@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Elham Zarean
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Parastar Ave, Hajar Hosp
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۶۸۵۴۶۳۳
Phone
+98 38 3222 0016
Email
ezarean@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Elham Zarean
Position
assistan professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Parastar Ave, Hajar Hosp
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۶۸۵۴۶۳۳
Phone
+98 38 3222 0016
Email
ezarean@gmail.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
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available