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IRCT20140113016200N2 IRCT 2019-03-04 Shahid Beheshti University of Medical Sciences The Evaluation of minocycline effect in patients with resistant malignant ascites The Evaluation of minocycline effect on reducing the volume of ascites and the tumor markers of VEGF and IL-6 before and after the usage of the drug in patients with resistant malignant ascites 2019-03-06 anticipated 6 Complete https://irct.ir/trial/15237 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2 resistant malignant ascites. Intervention group: Minocycline Tablet with escalating dose. Yes - There is a plan to make this available What will be shared: All data obtained from this study, except for the patient's profile, can be shared. When: Almost one year To whom: everyone Conditions: Use of all the data is possible by mentioning the source. Where to obtain: Dr. Khojasteh Joharchi MD. Ph.D. of Pharmacology Dep. of Pharmacology & Neuroscience Research Center 5th floor, School of Medicine Shahid Beheshti University of Medical Sciences Koodakyar Ave, Daneshjoo Blvd., Evin, Tehran, Islamic Republic of Iran P.O.Box: 19615-1179 Tel: +98-21- 23872539 Fax: +98-21- 22439969 E-mails: Joharchi-kh@sbmu.ac.ir khojastehjoharchi@gmail.com How to obtain: After a written request and after the necessary checks, they will be answered within a maximum of one week by email. Comments:
public Khojasteh Joharchi
Pharmacology Department, 5th floor, School of Medicine, Shahid Beheshti University of Medical Sciences, Koodakyar st., Daneshjoo blvd., Evin
Tehran Iran (Islamic Republic of) 1985717443 +98 21 2387 2539 joharchi-kh@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Khojasteh Joharchi
Pharmacology Department, 5th floor, School of Medicine, Shahid Beheshti University of Medical Sciences, Koodakyar st., Daneshjoo blvd., Evin, Tehran
Tehran Iran (Islamic Republic of) 1985717443 +98 21 2387 2539 joharchi-kh@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Have metastatic progressive cancer and resistant malignant ascites with no answer to the routine treatments. older than 18 years. Complete written informed consent form in accordance with Ministry of Health guidelines included in this study. Have healthy liver and kidney function. Have estimated lifetime of at least 12 weeks. Should have a measurable disease according to the criteria for evaluation of response to solid tumors (RECIST). At least 3 weeks after the past chemotherapy for improvement of reversible side effects (and at least 6 weeks for chemotherapy drugs that have toxic effects on the stem cells) At least 2 weeks away from previous radiotherapy and in general less than 25% of the bone marrow should be exposed. A patient with previously treated CNS metastasis is eligible only if there is no clinical or radiological evidence of CNS disease progression. Before starting the treatment, complete medical history and physical examination, measurement of height, weight, vital signs, pain score, ECOG score (this test indicates an increase in internal ear pressure in some patients), urine test, pregnancy test, Chest X-ray, ECG, serum biochemical testing including glucose and Cholesterol, electrolytes, urea, creatinine, complete blood count, liver function tests, and measuring tumor markers and VEGF and IL-6 have been done. 18 years no limit Both Ascites caused by other factors (e.g., kidney or heart failure, severe liver dysfunction / or occlusion of portal vein and peritoneal inflammation). Severe malnutrition or indigestion (with a BMI less than 19 kg / cm2 and/or hypoproteinemia with serum albumin less than 20 g/ L). Inadequate blood function (Total neutrophil count less than 1500 / MM3 and platelet less than 100,000 / MM3). Severe infection requiring treatment. Coagulopathy or Encephalopathy. Other severe complications that are diagnosed by early examination, such as pregnancy or lactation or psychiatric disorders. C78.6 Secondary malignant neoplasm of retroperitoneum and peritoneum, Malignant ascites NOS Treatment - Drugs Intervention group: Minocycline Tablet with escalating dose The volume of ascitic fluid, CA125, VEGF, IL-6. Timepoint: Once at the beginning, then every two weeks for two months. Method of measurement: Ultrasound + ascitic fluid and blood sampling. Shahid Beheshti University of Medical Sciences Approved 2018-02-18 Research Department of the School of Medicine Shahid Beheshti University of Medical Sciences School of Medicine, Shahid Beheshti University of Medical Sciences, Koodakyar st., Daneshjoo Blvd., Evin Tehran Tehran Iran (Islamic Republic of)