NCT06039644

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
8mo left

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Apr 2024Dec 2026

First Submitted

Initial submission to the registry

September 6, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 15, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

April 8, 2024

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

2.7 years

First QC Date

September 6, 2023

Last Update Submit

March 5, 2026

Conditions

Breast Cancer

Keywords

probioticschemotherapy side-effectsBreast carcinomagut microbiotLactobacillus reuteriLactobacillus plantarumLactobacillus paracasei

Outcome Measures

Primary Outcomes (1)

  • Change from 12 weeks in the chemotherapy associated side-effects questionnaire at 24 weeks

    The questionnaire will finished to record the side effects, including nausea, vomiting, diarrhea, stomatitis, peripheral neuropathy, skin rashes, and hand-food syndrome before and after the treatment.

    24 weeks

Secondary Outcomes (24)

  • Change from 12 weeks in self-record of the FACT-G questionnaire (The Functional Assessment of Cancer Therapy - General; Version 4) at 24 weeks

    24 weeks

  • Variability in BMI (Body Mass Index)

    24 weeks

  • Change from baseline in levels of hs-CRP (high-sensitivity C-Reactive Protein) in mg/dL at 12 weeks

    12 weeks

  • Change from baseline in levels of hs-CRP (high-sensitivity C-Reactive Protein) in mg/dL at 24 weeks

    24 weeks

  • Change from baseline in levels of IL-6 (Interleukin-6) in pg/mL at 12 weeks

    12 weeks

  • +19 more secondary outcomes

Study Arms (2)

Probiotic group

EXPERIMENTAL

Subjects received two probiotic sachets per day

Dietary Supplement: Probiotic

Placebo group

PLACEBO COMPARATOR

Subjects received two placebo sachets per day

Other: Placebo

Interventions

ProbioticDIETARY_SUPPLEMENT

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

Also known as: Test group
Probiotic group
PlaceboOTHER

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

Also known as: Control group
Placebo group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mackay Memorial Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

ProbioticsControl Groups

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Po-Sheng Yang, MD, PhD

    Mackay Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fang-Kuei Lin, Master

CONTACT

+886-6-505-2151meitung@genmont.com.tw

Wan-Hua Tsai, PhD

CONTACT

+886-6-505-2151twh@genmont.com.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Parallel Assignment, Randomized Controlled Trial
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2023

First Posted

September 15, 2023

Study Start

April 8, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

March 6, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)