To Evaluate the Clinical Efficacy of Probiotics in Patients With the Breast Cancer

GenMont Biotech

Status: Enrolling

Conditions: Breast Cancer

Treatments: Other: Placebo; Dietary Supplement: Probiotic

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06039644

BC2023

Details and patient eligibility

About

Chemotherapy-associated side-effects would affect therapeutic effect, quality of life, and cause permanent harm to breast cancer patients. This study is designed to explore after consumption of probiotics of lactobacillus composite strain powder sachets for 6 months in breast cancer chemotherapy, and whether the improvement of meliorate the side effects, further assists patients completing the chemotherapy.

Full description

In 2020, the incidence rate of women's breast cancer in Taiwan was up to 82.1% . The death rate increased to 16%; in 2021, the ranking rose to no.3, and the death rate grew up to 24.6%. In the decades, breast cancer gradually becomes the dominant malignant women's cancer in Taiwan. Besides the lumpectomy, chemotherapy is one of the dominant and important treatments for breast cancer. Beyond the effects of chemotherapy, several side effects rise up. The most common chemotherapy are anthracyclin drugs (doxorubicin and epirubicin) and taxane (docetaxel and paclitaxel ). There are common side effects including neutropenia, hair loss, vomiting, diarrhea, stomatitis, mucositis, peripheral neuropathy, dermatitis, nephrotoxicity, and hepatotoxicity. Currently, most treatments for chemotherapy-induced side effects are symptomatic treatment, but there is no good solution to prevent it.

Enrollment: 100 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Stage I-III breast patients using anthracycline-based and taxane-based chemotherapy (not limited before or after chemotherapy/surgery)
• BMI > 18 kg/m^2
• Age between 20 and 80 years old
• Patients judged by physicians to participate in this trial and who are willing

Exclusion criteria

• Pregnant or lactating female patients
• Patients with bariatric surgery, gastrointestinal resections, Crohn's disease, celiac disease
• BMI < 18 kg/m^2
• Patient who have severe allergy to soybeans or peanuts
• Those who are under 20 years old or over 80 years old

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Probiotic group

Experimental group

Description:

Subjects received two probiotic sachets per day

Treatment:

Dietary Supplement: Probiotic

Placebo group

Placebo Comparator group

Description:

Subjects received two placebo sachets per day

Treatment:

Other: Placebo