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IRCT20091114002709N56 IRCT 2021-05-05 Iran University of Medical Sciences The Effects of synbiotic supplementation in reducing of Chemotherapy-induced side effects in women with Breast Cancer The Effects of synbiotic supplementation in reducing of Chemotherapy-induced side effects in women with Breast Cancer 2021-05-22 anticipated 72 Complete https://irct.ir/trial/54559 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization will be done by the restricted randomization method: first people in terms of age (18 to 40 years and 40 to 70 years) and body mass index (18.5 to 24.9 and 25 to 29.9) in quadratic blocks (A, B, C and D) will be placed. Then, random allocation of people in each block to intervention and control groups will be done. random allocation of individuals to intervention and control groups, will be performed by means of software, Blinding description: This study will be triple-blinded, so that information analysts, researchers and all participants are unaware of intervention and control groups. While one of the classmates unrelated to the project is aware of the study groups. 3 chemotherapy-induced side effects. Intervention 1: Intervention group: Patients will be given two capsules of lactocare synbiotic daily for 6 weeks. Lactocare Synbiotic Capsules are manufactured by Zist Takhmir Company .Lactocare is an oral capsule containing high levels of beneficial bacteria (Lactobacilli, Bifidobacteria and Streptococcus) with prebiotic fructo-oligosaccharide (contributing to growth and probiotic activity). Intervention 2: Control group: Patients consume two placebo capsules twice a day for 6 weeks. Placebo capsules Are produced by Zist Takhmir company. Yes - There is a plan to make this available What will be shared: Some of the data will be shared, such as information about the main consequences and etc. When: The access period will be 6 months after publication of the results To whom: The obtained data from current study will be available only for researchers working in academic and scientific institutions Conditions: Six months after the publication of the papers from this study, the data obtained will be available to the applicant researchers for further analysis Where to obtain: Applicants can be contacted with correspond author by e-mail or postal address to receive the requested data. Postal address: Nutrition department, School of health, Iran University of Medical Sciences, Hemmat expressway, Tehran Phon number:0098 21 8862 2755 E-mail: Farzadshidfar@yahoo.com How to obtain: Applicants will be able to access the obtained data from current study by sending an email to the corresponding author, after a maximum of one week Comments:
public Farzad SHidfar
School of Health, Iran University of Medical Science, Shahid Hemmat highway
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8862 2755 Shidfar.f@iums.ac.ir Iran University of Medical Sciences scientific Farzad SHidfar
School of Health, Iran University of Medical Sciences, Shahid Hemmat highway
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8862 2755 shidfar.f@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Definitive diagnosis of breast cancer by oncologist and pathologist Receiving one-day chemotherapy courses Stage 1 to 3 of breast cancer (pre-metastatic stages) History of complications following previous chemotherapy sessions no history of gastrointestinal problems before breast cancer at least one and at last two previous sessions of chemotherapy Do not consuming probiotic dairy products or any foods containing probiotic or prebiotic compounds, or their supplements in the past two weeks. Age 18 years and older Willingness to cooperation 18 years no limit Female Chronic diseases such as hypertension, coronary heart disease, history of stroke, liver failure (ALT and AST levels > 100 IU / L), renal failure (serum creatinine levels > 1.7 mg / dl), impaired cell count (WBC > 20,000 U / L, hemoglobin less than 10 mg / dl, platelets <15,000 / mcL or >400,000 / mcL) and gastrointestinal problems Body mass index >30 kg / m2 History of tumor in other organs or metastasis to other organs taking medicines or other treatments to reduce nausea (Except for the usual anti-nausea and vomiting medicines) Severe gastrointestinal problems and complications during the study Neutropenic patients Consumption of probiotic dairy products or any foods containing probiotic or prebiotic compounds, or their supplements during the study Recent infection or recent use of antibiotics in the past three months Receiving radiation therapy and chemotherapy simultaneously Not willing to continue cooperation Rehabilitation Placebo Intervention group: Patients will be given two capsules of lactocare synbiotic daily for 6 weeks. Lactocare Synbiotic Capsules are manufactured by Zist Takhmir Company .Lactocare is an oral capsule containing high levels of beneficial bacteria (Lactobacilli, Bifidobacteria and Streptococcus) with prebiotic fructo-oligosaccharide (contributing to growth and probiotic activity) Control group: Patients consume two placebo capsules twice a day for 6 weeks. Placebo capsules Are produced by Zist Takhmir company Experience and severity of nausea. Timepoint: One hour before receiving chemotherapy drugs in the first, second and third visit. Method of measurement: McGill Nausea and Vomiting Questionnaire. Experience and severity of vomiting. Timepoint: One hour before receiving chemotherapy drugs in the first, second and third visit. Method of measurement: McGill Nausea and Vomiting Questionnaire. Experience and severity of diarrhea. Timepoint: One hour before receiving chemotherapy drugs in the first, second and third visit. Method of measurement: Bristol Diarrhea and Constipation Scale. Experience and severity of constipation. Timepoint: One hour before receiving chemotherapy drugs in the first, second and third visit. Method of measurement: Bristol Diarrhea and Constipation Scale. Experience and severity of fatigue. Timepoint: One hour before receiving chemotherapy drugs in the first, second and third visit. Method of measurement: CFS questionnaire. Experience and severity of chemotherapy-induced pain. Timepoint: One hour before receiving chemotherapy drugs in the first, second and third visit. Method of measurement: McGill Pain Questionnaire. Sleep quality. Timepoint: One hour before receiving chemotherapy drugs in the first, second and third visit. Method of measurement: PSQL questionnaire. Experience and severity of anorexia. Timepoint: One hour before receiving chemotherapy drugs in the first, second and third visit. Method of measurement: FAACT questionnaire. Psycho-emotional status. Timepoint: One hour before receiving chemotherapy drugs in the first, second and third visit. Method of measurement: PHQ-9 questionnaire. Iran University of Medical Sciences Approved 2021-04-18 Ethics committee of Iran University of Medical Sciences Hemat Express way, Iran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)