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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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20140113016200N2
Enrollment
6
Registered
2019-03-04
Start date
2019-03-06
Completion date
Unknown
Last updated
2019-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

resistant malignant ascites. Secondary malignant neoplasm of retroperitoneum and peritoneum, Malignant ascites NOS

Interventions

Intervention group: Minocycline Tablet with escalating dose.

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactKhojasteh Joharchi

Shahid Beheshti University of Medical Sciences

joharchi-kh@sbmu.ac.ir+98 21 2387 2539

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026