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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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20091114002709N56
Enrollment
72
Registered
2021-05-05
Start date
2021-05-22
Completion date
Unknown
Last updated
2021-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chemotherapy-induced side effects.

Interventions

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

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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 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

Design outcomes

Primary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFarzad SHidfar

Iran University of Medical Sciences

Shidfar.f@iums.ac.ir+98 21 8862 2755

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 10, 2026