The effect of Beta Glucan and both of Beta Glucan and Lactobacillus Rhamnosus GG on immune system , nutritional status and side effects of chemptherapy in breast cancer pateints
Object of study: Determination the effect of beta glucan and both of beta glucan and lactobacillus rhamnosus GG on immune system, nutritional status and side effects of chemotherapy in breast cancer patients. Study design: random, double blind, control with placebo, one research center. Study population: breast cancer patients in stages 2 and 3 of disease randomly divided into 3 groups:1- beta glucan(20 mg/d),2-beta glucan(20 mg/d) with lactobacillus rhamnosus GG (2*107 CFU) and control group will receive placebo. Study groups will receive capsules between two chemotherapies, during 21 days. Inclusion criteria: physician definitive diagnosis of breast cancer; receiving chemotherapy; no allergies to molds and yeasts; adequate bone marrow function; proper function of kidney; absence of other acute medical conditions; aged 20 years and older. Exclusion criteria: patient reluctance to participate in the study; pregnant women; lactating women; existence the acute medical illness. Sample size: 45 patients (15 patients in 3 groups). Study interventions: 1-beta glucan 2- beta glucan and lactobacillus rhamnosus GG. Intervention duration: 21 days, between 2 chemotherapies. Primary outcome: the effect of supplements on CBC, CD4, CD45RA, IL-4, IL-12. Secondary outcome: the effect of supplements on nutrition status and the quality of life in patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201212172017N10
Registration date:2013-02-10, 1391/11/22
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-02-10, 1391/11/22
Registrant information
Name
Alireza Ostadrahimi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7580
Email address
ostadrahimi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Hemotology Oncology Research Center, Tabriz University of Medical Sciences
Expected recruitment start date
2013-02-19, 1391/12/01
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Beta Glucan and both of Beta Glucan and Lactobacillus Rhamnosus GG on immune system , nutritional status and side effects of chemptherapy in breast cancer pateints
Public title
The effect of Beta Glucan and both of Beta Glucan and Lactobacillus Rhamnosus GG on immune system , nutritional status and side effects of chemptherapy in breast cancer patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: physician definitive diagnosis of breast cancer; receiving chemotherapy; the ability to drink at least 100 ml of water per day; life expectancy and survival at least 3 months; no allergies to molds and yeasts; adequate bone marrow function; proper function of kidney; absence of other acute medical conditions and aged 20 years and older. Exclusion criteria: patient reluctance to participate in the study; pregnant women; lactating women and existence the acute medical illness.
Age
From 20 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
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
Tabriz University of Medical Sciences
Street address
Tabriz-Golgasht Street-Tabriz University of Medical Sciences- Central Building Number 2-Third Floor- Research Vice-Chancellor
City
Tabriz
Postal code
Approval date
2013-01-07, 1391/10/18
Ethics committee reference number
91172
Health conditions studied
1
Description of health condition studied
Breast Cancer
ICD-10 code
C50
ICD-10 code description
Malignant Neoplasm of Breast
Primary outcomes
1
Description
Improvement of Immune System
Timepoint
Immediately After the Intervention
Method of measurement
CBC,CD4,CD45,IL-4,IL-12
Secondary outcomes
1
Description
Improved Chemotherapy Side Effects
Timepoint
Immediately After the Intervention
Method of measurement
Questionnair
2
Description
Improved Nutrition Status
Timepoint
Immediately After the Intervention
Method of measurement
Anthropometric Assessment
Intervention groups
1
Description
Beta Glucan 10 mg, 2 tablets a day 21 days
Category
Treatment - Other
2
Description
Beta Glucan 10 mg, 2 tablets a day 21 days with Lactobacillus Rhamnosus GG (2*107 CFU) for 21 days
Category
Treatment - Other
3
Description
Placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Ghazi Tabatabaye Hospital
Full name of responsible person
Dr. Alireza Ostad rahimi
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hematology Oncology Research Center, Tabbriz University of medical Sciences
Full name of responsible person
Dr. Jamal Eivazi
Street address
Tabriz,Ghazi Hospital,Hematology Oncology Research Center
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hematology Oncology Research Center, Tabbriz 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
Faculty of Nutrition, Tabriz University of Medical Sciences
Full name of responsible person
Nazila Farrin
Position
Ph.D Candidate of Nutrition Sciences
Other areas of specialty/work
Street address
Faculty of Nutrition,Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 1335 7580
Fax
Email
nazilafarrin@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nutrition, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Alireza Ostadrahimi
Position
Ph.D of Nutrition Sciences
Other areas of specialty/work
Street address
Tabriz-Golgasht Avenue, Attar Neishaboori Street- Faculty of Nutrotion
City
Tabriz
Postal code
Phone
+98 41 1335 7580
Fax
Email
ostadrahimi@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Nutrition, Tabriz University of Medical Sciences
Full name of responsible person
Nazila Farrin
Position
Ph.D Candidate of Nutrition Sciences
Other areas of specialty/work
Street address
Tabriz-Golghasht Street, Attare Neyshabori Avenue, Faculty of Nutrition
City
Tabriz
Postal code
Phone
+98 41 1335 7580
Fax
Email
nazilafarrin@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)