Effects of Lactobacillus acidophilus probiotic as an adjuvant therapy with the standard treatments on the immune system and treatment efficacy in patients with locally advanced rectal cancer: Phase III randomized clinical trial
Current study is aimed to investigate the effects Lactobacillus acidophilus as an adjuvant therapy with standard treatments, by improving the immune system function in patients with rectal cancer. 150 patients who will refer to Firoozgar and Imam Khomeini Hospital randomly from summer 95 to March 96. The patients will be block randomization divided into two 75-patient groups. The case group will receive Lactobacillus acidophilus capsule (1.5 g/daily, produced by Zist Takhmir Co), and the control group will receive the placebo capsules from one day before chemo-radiation to one week before surgery for 13 weeks. At the beginning and the end of study, answering to the questionnaire and related forms (CRF, FFQ), height and weight measurement and blood sampling will be performed by an expert person. Furthermore, at the end of 13th week, CT Imaging will be done on the patient for reinvestigation of tumor size under the clinical diagnosis. The tests carried out on serum samples include ELISA technique for evaluating the serum levels of cytokines, Real-time PCR for measuring the expression of STAT4 gene, and Flowcytometry for CDs measurement.
General information
Acronym
LA5 and CRC
IRCT registration information
IRCT registration number:IRCT2016061118745N8
Registration date:2016-06-28, 1395/04/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-06-28, 1395/04/08
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
Iran University of Medical Seiences
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Lactobacillus acidophilus probiotic as an adjuvant therapy with the standard treatments on the immune system and treatment efficacy in patients with locally advanced rectal cancer: Phase III randomized clinical trial
Public title
The effects of Lactobacillus acidophilus probiotic capsule administration on the immune system and treatment efficacy in patients with rectal cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : Patient with locally advanced rectal cancer ; Patient with non-metastatic rectal cancer; Voluntary participation in the study and informed consent form fulfilling; Lack of swallowing disorder.
Exclusion criteria : Patients with other cancers; Patients with renal and hepatic disorders; Patients with intestinal obstruction; Patients with low level of white blood cells (less than 1000 cells per mm3); Patients with drug intolerance or drug sensitivity to probiotics.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
150
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
Ethics committee of Iran University of Medical Sciences
Street address
Tehran, Hemmat Highway,Iran University of Medical Sciences
City
Tehran
Postal code
Approval date
2016-03-02, 1394/12/12
Ethics committee reference number
IR.IUMS.REC.1394/19753
Health conditions studied
1
Description of health condition studied
locally advanced rectal cancer
ICD-10 code
C20
ICD-10 code description
Malignant neoplasm of rectum
Primary outcomes
1
Description
Destroy of tumor or decrease of tumor size
Timepoint
The beginning and end of the study
Method of measurement
CT
Secondary outcomes
1
Description
STAT4 gene expression
Timepoint
The beginning and end of the study
Method of measurement
Real-time PCR
2
Description
the serum levels of cytokines
Timepoint
The beginning and end of the study
Method of measurement
ELISA technique
3
Description
CDs measurement
Timepoint
The beginning and end of the study
Method of measurement
Flowcytometry
Intervention groups
1
Description
Intervention group: The case group will receive Lactobacillus acidophilus capsule (1.5 g/daily, produced by Zist Takhmir Co) from one day before chemo-radiation to one week before surgery for 13 weeks.
Category
Treatment - Drugs
2
Description
Control group will receive the placebo capsules from one day before chemo-radiation to one week before surgery for 13 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Cancer Research Center, Cancer Institute of IR. Iran, Imam Khomeini Hospital
Full name of responsible person
Dr. Ali Mohammad Alizadeh
Street address
3rd Fl. of Radiotherapy Bldg, Cancer Institute, Imam Khomeini Hospital, Keshavarz Boulevard, Tehran, Iran