Lactobacillus acidophil probiotic effects as an adjunctive therapy together standard drugs on side effects, treatment response and quality of life in patients with rectum cancer: Double Blind Randomized Clinical Trial
Colorectal cancer is the third and the second most common cancer in the world and Iran, respectively. Scientists specialists suggested “Biological therapy” as a low cost and safe biological method for the treatment or the prevention of colorectal cancer. Our previous studies in animal colon cancer showed that the use of some probiotic strains such as Lactobacillus acidophilus in comparison with Bifidobacterium can reduce the incidence of cancer and tumor markers. In this present study randomized clinical trial phase 3, we aimed effects of Lactobacillus acidophil probiotic as adjuvant therapy in combination with standard therapies on treatment response and quality of life in colorectal patients. The subjects included 300 patients with rectum cancer in the Imam Khomeini hospital (Tehran University of Medical Sciences hospital) and Hazrat Rasoul Akram hospital (Iran University of Medical Sciences) from January 2015 to January 2016. Patients were randomly divided into two separate blocks of 150 patients including (i) Lactobacillus acidophilus probiotic capsules with standard therapy group and (ii) standard treatment without any probiotic. Patients in the first group will receive Lactobacillus acidophilus probiotic, capsules 2.5 mg daily (three times, before each meal) for at least 5 months before to two months after surgery and radiotherapy. Assessments including the quality of life improving, CT scans imaging and tumor marker examinations were operated during and the end of study to evaluate response to therapy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014092118745N3
Registration date:2014-11-08, 1393/08/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-11-08, 1393/08/17
Registrant information
Name
Ali Mohammad Alizadeh
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2501
Email address
aalizadeh@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences and Iran University Of Medical Sciences
Expected recruitment start date
2014-10-01, 1393/07/09
Expected recruitment end date
2016-10-01, 1395/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Lactobacillus acidophil probiotic effects as an adjunctive therapy together standard drugs on side effects, treatment response and quality of life in patients with rectum cancer: Double Blind Randomized Clinical Trial
Public title
Lactobacillus acidophil probiotic effects in rectum cancer patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Randomized; with obtaining written consent; rectum cancer in neoadjuvant stage.
Exclusion criteria: Patients with kidney problems or liver problems; patients with serious heart problems; patients with metastatic lung and brain cancer; patients with intestinal obstruction; patients with GFR less 30; patients with immunodeficiency.
Age
From 20 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
300
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Keshavarz Bulvar, Porsina Street
City
Tehran
Postal code
134511345
Approval date
2013-08-20, 1392/05/29
Ethics committee reference number
93/130/1195
Health conditions studied
1
Description of health condition studied
Malignant neoplasms of digestive organs
ICD-10 code
C20-C21.2
ICD-10 code description
Malignant neoplasm of rectum, anus and anal canal whose point of origin cannot be classified to any one of the categories C20-C21.2
Primary outcomes
1
Description
Response to treatment
Timepoint
Before and after drug therapy, 5 months
Method of measurement
CT scan
Secondary outcomes
1
Description
The assesment of quality of life
Timepoint
Befor and after of treatment, 5 months
Method of measurement
Questionnaires of FACT and CARES
Intervention groups
1
Description
Patients will receive Lactobacillus acidophilus probiotic (capsules 500 mg, three times a day, before each meal) for at least 5 months before to two months after surgery and radiotherapy.
Category
Treatment - Drugs
2
Description
Patients will receive the placebo capsules of Lactobacillus acidophilus probiotic (three times a day, before each meal) for at least 5 months before to two months after surgery and radiotherapy.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Cancer Institute of Iran
Full name of responsible person
Dr. Ali Mohammad Alizadeh
Street address
Keshavarz Bulvar, Institut of Cancer
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Uonesian
Street address
Keshavarz Bulvar, Porsina Street.
City
Tehran
Grant name
Grant code / Reference number
93-01-51-25308
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Tehran University of Medical Sciences
Full name of responsible person
Dr. Ali Mohammad Alizadeh
Position
Ph.D, Assistant Professor
Other areas of specialty/work
Street address
Keshavarz Bulv, cancer insitute, cancer Research center
City
Tehran
Postal code
13145158
Phone
+98 21 6119 2501
Fax
+98 21 6119 2501
Email
aalizadeh@razi.tums.ac.ir
Web page address
www.pccrg.org
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Ebrahim esmati, Dr. Ali Mohammad Alizadeh
Position
Assistant professor, Assistant professor
Other areas of specialty/work
Street address
Keshavarz Bulvar, Cancer Institute of Iran
City
Tehran
Postal code
13145158
Phone
+98 21 6119 2501
Fax
+98 21 6119 2501
Email
e_esmati@yahoo.com; aalizadeh@razi.tums.ac.ir
Web page address
www.pccrg.org
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical of Sciences
Full name of responsible person
Dr. Ali Mohammad Alizadeh
Position
Ph.D, Asistant Professor
Other areas of specialty/work
Street address
Keshavarz Bulvar, Institut of Cancer, Cancer Research Center
City
Tehran
Postal code
13145158
Phone
+98 21 6119 2501
Fax
+98 21 6119 2501
Email
aalizadeh@razi.tums.ac.ir
Web page address
www.pccrg.org
Sharing plan
Deidentified Individual Participant Data Set (IPD)