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IRCT20170308032957N2 IRCT 2018-05-16 Isfahan University of Medical Sciences The effect of omega-3 on cancer related fatigue The effect of omega-3 on cancer related fatigue in cancer patients and its comparison with the control group 2017-08-06 anticipated 70 Complete https://irct.ir/trial/25555 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 cancer related fatigue. Intervention 1: 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). Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Mohammad Nouranian
Department of Social Medicine,Isfahan University of Medical Sciences
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 8123 Mohamednoranianmn7@gmail.com Department of Social and Family Medicine scientific Dr Houriye Ansari
Department of Social and Family Medicine
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 8123 houri_|ansari@yahoo.com Department of Social Medicine,Isfahan University io Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 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 30 years 60 years Both 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 R53.0 Neoplastic (malignant) related fatigue Treatment - Drugs Treatment - Drugs 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). 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. Cancer related fatigue. Timepoint: zero- 3 weeks-6 weeks. Method of measurement: multi variable Questionnaire. Adherence to treatment. Timepoint: zero-3 weeks-6 weeks. Method of measurement: Questionnaire(Morisky). Isfahan University of Medical Sciences Approved 2017-05-17 Isfahan University of Medical Science Isfahan Hezar jarib Street Isfahan Isfehan Iran (Islamic Republic of) Approved 2017-02-17 Isfahan University of Medical Science Hezaar Jarib Street Isfahan Isfehan Iran (Islamic Republic of)