Protocol summary

Study aim
To determine the efficacy of Minocycline in the treatment of malignant resistant ascites and to identify its mechanism and to specify the required dose by the Escalating method.
Design
This project will be conducted as a clinical study within 8 weeks. The number of patients according to the statistical calculations and the rarity of the conditions have been identified as 4, with a possible 25% drop, 6 patients will enter the study. At first, ascitic fluid volume is determined by ultrasound then samples are taken from the ascites fluid and blood. The collected blood and ascites samples on days 0, 15, 30, 45 and 60, a total of ten samples per patient, will be measured for tumor markers, VEGF and IL-6, before and after treatment with minocycline using ELISA kit and will be analyzed and compared at different times and doses. Meanwhile, the extent of the ascites fluid, which is determined by ultrasound, will be evaluated at different times.
Settings and conduct
Patients with malignant ascites referred to the oncology clinic of Taleghani Hospital of Shahid Beheshti University of Medical Sciences (Evin, Tehran), who are in the final stages of the disease and did not respond to other commonly used medications.
Participants/Inclusion and exclusion criteria
Patients with Advanced Cancer and Malignant resistant Ascites
Intervention groups
Evaluating the approximate ascites volume and treatment with escalating doses of minocycline and comparing each individual with him at different times and doses within two months
Main outcome variables
The volume of ascitic fluid, The tumor markers of VEGF (Vascular Endothelial Growth Factor) and IL-6 (Interleukin-6),

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20140113016200N2
Registration date: 2019-03-04, 1397/12/13
Registration timing: prospective

Last update: 2019-03-04, 1397/12/13
Update count: 0
Registration date
2019-03-04, 1397/12/13
Registrant information
Name
Khojasteh Joharchi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2387 2539
Email address
joharchi-kh@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-06, 1397/12/15
Expected recruitment end date
2020-03-05, 1398/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
The Evaluation of minocycline effect in patients with resistant malignant ascites
Purpose
Treatment
Inclusion/Exclusion 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:
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.
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 6
More than 1 sample in each individual
Number of samples in each individual: 1
In each participant, the volume of ascites will be measured and a sample of blood and a sample of ascites fluid will be taken before treatment with minocycline and after taking it every two weeks for two months totally five times.
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Department of the School of Medicine Shahid Beheshti University of Medical Sciences
Street address
School of Medicine, Shahid Beheshti University of Medical Sciences, Koodakyar st., Daneshjoo Blvd., Evin
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2018-02-18, 1396/11/29
Ethics committee reference number
IR.SBMU. MSP.REC.1396.803

Health conditions studied

1

Description of health condition studied
resistant malignant ascites
ICD-10 code
C78.6
ICD-10 code description
Secondary malignant neoplasm of retroperitoneum and peritoneum, Malignant ascites NOS

Primary outcomes

1

Description
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

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Minocycline Tablet with escalating dose
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
The Oncology department of Taleghani Hospital
Full name of responsible person
Dr. Tahereh Shirin Haghighi
Street address
Oncology department, 4th floor, Taleghani Hospital, Shahid Arabi St., Daneshjoo Blvd., Evin.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 2560
Fax
Email
drshirinhaghighi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Seyyed Ali Ziaei
Street address
Koodakyar st., Daneshjoo Blvd., Evin
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2387 2539
Fax
+98 21 2243 9969
Email
saziai@gmail.com
Grant name
Grant No 11708
Grant code / Reference number
کد ثبت 11708
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Khojasteh Joharchi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Pharmacology Department, 5th floor, School of Medicine, Shahid Beheshti University of Medical Sciences, Koodakyar st., Daneshjoo blvd., Evin
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2387 2539
Fax
+98 21 2243 9969
Email
joharchi-kh@sbmu.ac.ir
Web page address
https://www.linkedin.com/in/khojasteh-joharchi-7558a355/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Khojasteh Joharchi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Pharmacology Department, 5th floor, School of Medicine, Shahid Beheshti University of Medical Sciences, Koodakyar st., Daneshjoo blvd., Evin, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2387 2539
Fax
+98 21 2243 9969
Email
joharchi-kh@sbmu.ac.ir
Web page address
https://www.linkedin.com/in/khojasteh-joharchi-7558a355/

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Khojasteh Joharchi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
5th floor, Pharmacology Department, School of Medicine, Shahid Beheshti University of Medical Sciences, Koodakyar st., Daneshjoo blvd., Evin, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2387 2539
Fax
+98 21 2243 9969
Email
joharchi-kh@sbmu.ac.ir
Web page address
https://www.linkedin.com/in/khojasteh-joharchi-7558a355/

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data obtained from this study, except for the patient's profile, can be shared.
When the data will become available and for how long
Almost one year
To whom data/document is available
everyone
Under which criteria data/document could be used
Use of all the data is possible by mentioning the source.
From where data/document is obtainable
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
What processes are involved for a request to access data/document
After a written request and after the necessary checks, they will be answered within a maximum of one week by email.
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