The Glucuronic acid is an anti-inflammatory agent that belongs to the family of nonsteroidal anti-inflammatory drugs that it has shown the therapeutic effects with the greatest tolerability and safety in various experimental models. The aim of this study is to assess the safety and efficacy of Glucuronic acid in treatment of patients with breast cancer. In this study the most important inclusion criteria are histopathological certain results and tumoral mass existance, and the most important exclusion criteria are existance of infectious diseases and concomitant diseases. In this randomized, controlled trial, 36 patients with breast cancer fulfilling the American College of oncology Diagnostic Criteria will be examined. Patients will be randomly assigned to receive either Glucuronic acid day or conventional drugs (control group, 12 patients) orally for 12 weeks. The tumor size and serum level of CEA and CA15.3, will be evaluated at baseline and 12 weeks after treatment. In this study basically changes of tumor size and serum level of CA15.3 and CEA factors before and after treatment with this drug as the most important results this study will be examined.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017061113739N9
Registration date:2017-06-14, 1396/03/24
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-06-14, 1396/03/24
Registrant information
Name
Abbas Mirshafiey
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 4913
Email address
mirshafiey@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor for Research, Tehran University of Medical Sciences
Expected recruitment start date
2017-07-19, 1396/04/28
Expected recruitment end date
2017-12-21, 1396/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Glucuronic acid on processing of breast cancer disease
Public title
The therapeutic effect of Glucuronic acid in breast cancer patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: 30-60 years old patients, Diagnosed with breast cancer according to American College of oncology Diagnostic Criteria after the initial visit by a specialist in cancer surgery and parameters CEA, CA15.3, CBC and sonography, Each patient must sign written informed consent. Exclusion Criteria: History of fever and Infectious diseases, Positive pregnancy test or Lactation, Other collagen- vascular and auto immune diseases, Patients have enrolled another clinical trial study within last 4 weeks, Other concomitant diseases (Hepatic, renal, haematological, gastrointestinal, endocrine, cardiovascular, pulmonary, neurological or cerebral disease).
Age
From 65 years old to 35 years old
Gender
Female
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
6th floor، central building of Tehran University of Medical Sciences، On the Corner of Keshavarz Blv
City
Tehran
Postal code
Approval date
2017-06-08, 1396/03/18
Ethics committee reference number
IR.TUMS.IKHC.REC.1396.2544
Health conditions studied
1
Description of health condition studied
Breast Cancer
ICD-10 code
C50.8
ICD-10 code description
Malignant neoplasm: overlapping lesion of breast
2
Description of health condition studied
Breast Cancer
ICD-10 code
C50.2
ICD-10 code description
Malignant neoplasm: upper-inner quadrant of breast
3
Description of health condition studied
Breast Cancer
ICD-10 code
C50.3
ICD-10 code description
Malignant neoplasm: lower-inner quadrant of breast
4
Description of health condition studied
Breast Cancer
ICD-10 code
C50.4
ICD-10 code description
Malignant neoplasm: upper-outer quadrant of breast
5
Description of health condition studied
Breast Cancer
ICD-10 code
C50.5
ICD-10 code description
Malignant neoplasm: lower-outer quadrant of breast
6
Description of health condition studied
Breast Cancer
ICD-10 code
C50.6
ICD-10 code description
Malignant neoplasm: axillary tail of breast
7
Description of health condition studied
Breast Cancer
ICD-10 code
C50.9
ICD-10 code description
Malignant neoplasm: breast, unspecified
8
Description of health condition studied
Breast Cancer
ICD-10 code
C50.0
ICD-10 code description
Malignant neoplasm: nipple and areola
Primary outcomes
1
Description
Feel the mass and tenacity in breast
Timepoint
At baseline and after 12 weeks of treatment
Method of measurement
Examination by specialist
Secondary outcomes
1
Description
Tumor size
Timepoint
At baseline and after 12 weeks of treatment
Method of measurement
Sonography
Intervention groups
1
Description
The intervention group will receive 1500 mg/day (three 500 mg tablets/day) of Glucuronic acid orally for 12 weeks. The Glucuronic acid produced from the decomposition of Alginate powder (a safe, natural substance used in food and pharmaceutical industries) purchased from Sigma Corporation of U.S.A, in central laboratory of immunology department of School of Public Health and Institute of Health Research of Tehran University of Medical Sciences.
Category
Treatment - Drugs
2
Description
Control group will receive of conventional drugs orally for 12 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Cancer Institute Of Emam Khomeini Hospital
Full name of responsible person
Dr. Habib allah Mahmodzade (MD. cancer sergeon)
Street address
Cancer Institute, Emam Khomeini Hospital,Keshavarz blv
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor for Research, Tehran University of Medical Sciences
Full name of responsible person
Dr. Masood Younesian (MD, PhD, Vice-Chancellor for Research, Tehran University of Medical Sciences)
Street address
6th floor, central building of Tehran University of Medical Sciences, On the Corner of Keshavarz Blvd. and Qods Street, Keshavarz Blvd., Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellor for Research, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Department of pathobiology, School of Public Health, Tehran University of Medical Sciences
Full name of responsible person
Dr. Abbas Mirshafiey
Position
PHD - Professor
Other areas of specialty/work
Street address
Department of pathobiology, School of Public Health, Tehran University of Medical Sciences,16 Azar St ,Enghelab Sq, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8895 4913
Fax
Email
mirshafiey@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of pathobiology, School of Public Health, Tehran University of Medical Sciences
Full name of responsible person
Dr. Abbas Mirshafiey
Position
PhD - Professor
Other areas of specialty/work
Street address
Department of pathobiology, School of Public Health, Tehran University of Medical Sciences,16 Azar St ,Enghelab Sq, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8895 4913
Fax
Email
mirshafiey@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)