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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-08

Study Completion Date

2026-04-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment, Randomized Controlled Trial

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Probiotic group

Subjects received two probiotic sachets per day

Group Type EXPERIMENTAL

Probiotic

Intervention Type DIETARY_SUPPLEMENT

Three-strain probiotic supplement includes Lactobacillus reuteri GMNL-89 (alive), Lactobacillus plantarum GMNL-141 (alive) and Lactobacillus paracasei GMNL-133 (alive).

Placebo group

Subjects received two placebo sachets per day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Same additives to Probiotic group but replace probiotics with corn starch and Maltodextrin.

Interventions

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Probiotic

Three-strain probiotic supplement includes Lactobacillus reuteri GMNL-89 (alive), Lactobacillus plantarum GMNL-141 (alive) and Lactobacillus paracasei GMNL-133 (alive).

Intervention Type DIETARY_SUPPLEMENT

Placebo

Same additives to Probiotic group but replace probiotics with corn starch and Maltodextrin.

Intervention Type OTHER

Other Intervention Names

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Test group Control group

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No