breast cancer patients undergoing chemotherapy.
Conditions
Interventions
Intervention 1: Intervention group: Intervention group: Daily one probiotic capsule with a dose of 1.8×10? CFU labeled as BioFlora® on the box and manufactured by Takgene Company, Tehran, Iran, contai
Sponsors
Kashan University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Breast cancer patients aged 18–65 years, Pathologically confirmed diagnosis of cancer by an oncologist, No metastasis to other body parts, Exclusion of advanced-stage cancer First-time candidates for chemotherapy, requiring at least 4 cycles of chemotherapy with the same regimen and drugs, No chronic comorbidities (e.g., liver disease, kidney failure, cardiovascular disease, etc.), No pre-existing gastrointestinal conditions (e.g., inflammatory bowel disease, irritable bowel syndrome, etc.), No immunodeficiency disorders, No probiotic supplement use within 2 weeks prior to the study, No active infection or antibiotic use in the past 3 months No history of surgery or trauma in the past 3 months.
Exclusion criteria
Exclusion criteria: Patients who fail to adhere to the regular intake of probiotic/placebo supplements, Patients who do not complete questionnaires or participate in follow-up phone calls, Patients who develop metastasis during the study, Patients who use additional medications (except for primary antiemetic treatments like those for nausea/vomiting), Patients who experience severe gastrointestinal adverse effects or other complications during the study, Patients who voluntarily withdraw or express unwillingness to continue participation Patients who consume less than 70% of the prescribed supplements during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Chemotherapy induced side effects include gastrointestinal symptoms such as nausea, vomiting, diarrhea, constipation, anorexia and dry mouth. Timepoint: On days 4-5 following each chemotherapy cycle. Method of measurement: CTCAE v.5 criteria. | — |
Secondary
| Measure | Time frame |
|---|---|
| Hematologic adverse effects of chemotherapy include anemia, leukopenia, and thrombocytopenia. Timepoint: during each chemotherapy. Method of measurement: Routine blood test session.;Quality of life. Timepoint: before first chemotherapy cycle and after final chemotherapy cycle. Method of measurement: Patient Health Questionnaire-9 (PHQ-9) scores".;Sleep quality. Timepoint: before first chemotherapy cycle and after final chemotherapy cycle. Method of measurement: Pittsburgh Sleep Quality Index (PSQI) questionnaires. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohsen Taghizadeh
Kashan University of Medical Sciences
Outcome results
None listed