The aim of this study was to evaluate the effect of omega-3 supplementation on cancer-related fatigue in cancer patients under chemotherapy and compare it with the effect of Ginseng on it.
Design
Clinical trials with control group with randomized, multifaceted, randomized,randomized groups
Settings and conduct
In the study of the effect of pharmacological interventions on cancer_related fatigue in chemotherapy clinics affiliated to Isfahan University of Medical Sciences
Participants/Inclusion and exclusion criteria
Entry requirements: Age 30 to 60 years, and lack of supplementation of omega-3 in the past 3 months and cancer_related fatigue during chemotherapy.
Intervention groups
Usage of omega-3 supplementation in intervention group and Ginseng consumption in control group
Main outcome variables
The main consequences are the improvement of various parameters of weakness including physical fatigue and ...in patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170308032957N2
Registration date:2018-05-16, 1397/02/26
Registration timing:retrospective
Last update:2018-05-16, 1397/02/26
Update count:0
Registration date
2018-05-16, 1397/02/26
Registrant information
Name
mohammad nouranian
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3274 2542
Email address
m_nouranian@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2017-08-06, 1396/05/15
Expected recruitment end date
2017-09-06, 1396/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of omega-3 on cancer related fatigue in cancer patients and its comparison with the control group
Public title
The effect of omega-3 on cancer related fatigue
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 30 to 60 years for participants
Have definite diagnosis of cancer and indicate chemotherapy or undergo chemotherapy
Cancer related fatigue in patients with a score of 40 and above in the questionnaire
Ability to read and write by patients
Ability to eat an oral medication by patients
Lack of supplementation of omega-3 in the last 3 months
Insensitivity to fish
Lack of use of anticoagulants(except aspirin)
Insensitivity to soy
Lack of anemia
Satisfaction of patients to participate in the study
Exclusion criteria:
Patient's death during the study
Having a disease that is not able to participate in the study
more than 20% of the questionnaire has not been completed
Age
From 30 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done by simple randomization method and generating random values between zero and one in the spss software. To assign random values to the intervention or control group using the lottery, values less than or equal to 0.5 are assigned to group A and values greater than 0.5 are assigned to group B. Then, by a person independent of the research team code 70 envelopes (based on the codes obtained in the above randomization method) and a list of codes is specified. In the envelope, based on the above method, a new treatment or standard treatment (conventional) will be written and, according to the entry of eligible patients, will be given to patients in the clinic to give an oncologist. The therapist provides the necessary prescriptions based on the groupings done for each patient. In the meantime, the researcher does not know which patient,in which group A or B, is.
Blinding (investigator's opinion)
Double blinded
Blinding description
The secretary introduced the patients to the oncologist using a randomized grouping and the oncologist provided treatments for both groups according to the grouping done.The investigator,in collaboration with the oncologist,supervised the patient's use of the drug. After collecting the questionnaire data was completed by the patients, the data was analyzed by a statistician specialist with respect to the confidentiality of the grouping.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Science
Street address
Isfahan Hezar jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2017-05-17, 1396/02/27
Ethics committee reference number
IR.MUI.REC.1396.3.182 396182
2
Ethics committee
Name of ethics committee
Isfahan University of Medical Science
Street address
Hezaar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2017-02-17, 1395/11/29
Ethics committee reference number
396182
Health conditions studied
1
Description of health condition studied
cancer related fatigue
ICD-10 code
R53.0
ICD-10 code description
Neoplastic (malignant) related fatigue
Primary outcomes
1
Description
cancer related fatigue
Timepoint
zero- 3 weeks-6 weeks
Method of measurement
multi variable Questionnaire
Secondary outcomes
1
Description
adherence to treatment
Timepoint
zero-3 weeks-6 weeks
Method of measurement
Questionnaire(Morisky)
Intervention groups
1
Description
Intervention group: In this group, patients receive 4 capsules each day of 250 mg of Ginseng capsule,which has Ginsin brand name and owned by the Iranian pharmaceutical company GOL DAROU, for 3 weeks and discontinues the drug for one week and re-use it for another 3 weeks (standard treatment). In addition, during this period, patients receive a capsule of 1 gram of omega-3 daily from the Australian Pharmaceutical Company GMV with a health certificate of 70009004710001 with the main meal for 6 weeks (new treatment).
Category
Treatment - Drugs
2
Description
control group: In this group, patients receive 4 capsules each day of 250 mg of Ginseng capsule,which has Ginsin brand name and owned by the Iranian pharmaceutical company GOL DAROU, for 3 weeks and discontinues the drug for one week and re-use it for another 3 weeks (standard treatment). The duration of the drug is 6 weeks in total.