The effect of probiotic ice cream contained ß-glucan on immune function in breast cancer patients

Phase 3

• Conditions: Breast Cancer.; Malignant neoplasm of unspecified site of unspecified female breast; C50.919

• Registration Number: IRCT20190822044579N1
• Lead Sponsor: Research Institute of Food Science and Technology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

Patients who have undergone chemotherapy and radiation therapy
Having an absolute number of neutrophils more than 1500 and platelets more than 150,000 per cubic millimeter of blood
No evidence of infection at the start of the tests
Obtain patient satisfaction before entering the study

Exclusion Criteria

People with uncontrolled diabetes
People with a BMI over 29.9

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determining the amount of Ig G and comparing its results in the four groups studied. Timepoint: At the beginning of the study (before the intervention) and 30 days after consuming ice cream. Method of measurement: Using ELISA Kit and ELISA Reader.;Determining the amount of TNF-alfa and comparing its results in the four groups studied. Timepoint: At the beginning of the study (before the intervention) and 30 days after consuming ice cream. Method of measurement: Using ELISA Kit and ELISA Reader.;Assessing the satisfaction score of the study groups based on the EORTC QLQ-C30 standard questionnaire and comparing the results in the four groups. Timepoint: At the beginning of the study (before the intervention) and 30 days after consuming ice cream. Method of measurement: EORTC QLQ-C30 standard questionnaire.

Secondary Outcome Measures

Name	Time	Method
Evaluation of decrease or increase in serum Ig G levels in the studied groups and their comparison with each other. Timepoint: At the beginning of the study and 30 days after consuming ice cream samples. Method of measurement: Using ELISA kit and reader and statistical analysis of data and comparison of results with control sample.;Evaluation of decrease or increase in TNF-alfa levels in the studied groups and their comparison with each other. Timepoint: At the beginning of the study and 30 days after consuming ice cream samples. Method of measurement: Using ELISA kit and reader and statistical analysis of data and comparison of results with control sample.;Comparison of the scores obtained for the satisfaction questionnaire between the tested groups. Timepoint: At the beginning of the study and 30 days later. Method of measurement: Statistical analysis of the results and comparison of means with the control sample.