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IRCT20200626047927N1 IRCT 2020-07-11 Shahed University Evaluation of the Effect of ACA1 on Gastric adenocarcinoma: Evaluation of the Effect of ACA1 on the Quality of Life in Patients with Gastric adenocarcinoma: a pilot study 2020-07-22 anticipated 20 Complete https://irct.ir/trial/49254 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: The method of allocating samples in this study is stratified randomization. Initially, patients eligible for study based on gender and initial performance (according to the ECOG table) were divided into four groups (first group: male, 0 performance), (second group: male, 1 performance), (third group: female, 0 performance), (Group 4: female, 1 Performance ) are divided. Patients in each group are then assigned to two groups of drugs and placebo based on a table of random numbers, Blinding description: A pharmacist at Shahed University Research Center prepares and codes the drug and placebo in such a way that they do not differ in weight, shape, color, odor or taste. He packs medicine and placebo in packs and gives them to the researcher. This person will not provide researchers with information about the samples until after the data analysis. All participants in this project and the clinical caregiver of the drug provider to the participants and the physician (the main researcher of the project) who is also responsible for data collection are unaware of the type of drug. 3 Gastric adenocarcinoma. Intervention 1: Intervention group: This group was treated with ACA1 capsules for 2100 mg per day for one month. Intervention 2: Control group: This group is treated with placebo capsules three times a day for a month. Yes - There is a plan to make this available What will be shared: The information about the main outcome will shared. When: The access period begins 6 months after publishing of results. To whom: It will be accessible to everyone. Conditions: For scientific works with observing the principles of research ethics Where to obtain: Zahra Sharifan, Mobile number: 00989125501170, Email: z.Sharifan@shahed.ac.ir, Address: No. 51, Golestan yak Ave, Pasdaran Ave, Tehran How to obtain: Upon confirmation of the scientific identity of the Iranian questioner, he or she will be provided as soon as possible. Comments:
public Zahra Sharifan
No.51, Golestan yek Ave, Pasdaran Ave
Tehran Iran (Islamic Republic of) 1666737133 +98 21 2257 2759 z.Sharifan@shahed.ac.ir Shahed University scientific Zahra Sharifan
No.51, Golestan yek Ave, Pasdaran Ave
Tehran Iran (Islamic Republic of) 1666737133 +98 21 2257 2759 z.Sharifan@shahed.ac.ir Shahed University Iran (Islamic Republic of) Patients with gastric adenocarcinoma whose disease has been confirmed histologically, are in the metastatic stage and at least two common chemotherapy treatments have been administered to them and the disease is not under control. Adequate bone marrow function: 4000<WBC<12000, Neutrophyl>1500, Plt>100000, Hb>8 Adequate liver function: Total Bill>1.5, AST&ALT<100 Adequate kidney function: Cr<1.5 performance status≤1 no limit no limit Both positive serology for HIV, HBV, HCV Metastasis to CNS other malignancies C16 Malignant neoplasm of stomach Treatment - Drugs Treatment - Drugs Intervention group: This group was treated with ACA1 capsules for 2100 mg per day for one month. Control group: This group is treated with placebo capsules three times a day for a month Quality of Life. Timepoint: Start of study (before the start of the intervention) and one month after the start of ACA1 consumption. Method of measurement: EORTC-QLQ-30 Standard questionnaire. White Blood Cell Count. Timepoint: Start studying (before starting the intervention) and one month after starting ACA1 consumption. Method of measurement: Cell Counter. Hemoglobin. Timepoint: Start studying (before starting the intervention) and one month after starting ACA1 consumption. Method of measurement: Cell Counter. Platelet Count. Timepoint: Start studying (before starting the intervention) and one month after starting ACA1 consumption. Method of measurement: Cell Counter. Body Mass Index. Timepoint: Start studying (before starting the intervention) and one month after starting ACA1 consumption. Method of measurement: Meter and scale. Shahed University Approved 2020-06-15 Ethics committee on Biomedical Research of Shahed University Shahed University, Persian Gulf Highway (Tehran - Qom), Tehran Tehran Tehran Iran (Islamic Republic of)