NCT07503496

Brief Summary

This study aims to evaluate the potential supportive effects of rice bran arabinoxylan compound (Biobran) in patients with breast cancer receiving paclitaxel and doxorubicin chemotherapy. The study will assess chemotherapy-related side effects, quality of life, tumor size, tumor antigens, and routine blood test parameters over 24 weeks of treatment.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Apr 2025

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress96%
Apr 2025Aug 2026

Study Start

First participant enrolled

April 7, 2025

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 31, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

1.4 years

First QC Date

March 19, 2026

Last Update Submit

March 25, 2026

Conditions

Breast Cancer Stages IBreast Cancer Stages IIBreast Cancer Stage III

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in the mean quality of life score at 12 weeks

    EORTC QLQ-BR42 scores range from 0 to 100. For symptom scales and single-item measures, higher scores indicate greater symptom burden or more severe problems, whereas lower scores indicate fewer symptoms or problems.

    Baseline and at 6、12、18、24 weeks after chemotherapy

Study Arms (2)

Placebo

NO INTERVENTION

3 g placebo per day for 24 weeks

Biobran

EXPERIMENTAL

3 g Biobran per day for 24 weeks

Dietary Supplement: Biobran supplementation

Interventions

Biobran supplementationDIETARY_SUPPLEMENT

3 g Biobran per day for 24 weeks

Biobran

Eligibility Criteria

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

You may qualify if:

  • Breast cancer stage I-III

You may not qualify if:

  • pregnant, lactation, breast recurrence, mental disease, autoimmune disease over hte past 5 years, people who take plant or fungal polysaccharide health supplements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

China Medical University Hospital

Taichung, 406040, Taiwan

RECRUITING

China Medical University

Taichung, 406040, Taiwan

NOT YET RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Chong-Kuei Lii, PhD

CONTACT

+886916226551cklii@mail.cmu.edu.tw

Yi-Chen Huang, PhD

CONTACT

886915754860yichenhuang@mail.cmu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2026

First Posted

March 31, 2026

Study Start

April 7, 2025

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

March 31, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Patent apply

Locations

TW(2)