Evaluation of the Efficacy of Biobran (Rice Bran Arabinoxylan) in Supporting Breast Cancer Chemotherapy

March 25, 2026 updated by: China Medical University Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Breast cancer is one of the leading causes of cancer-related death among women in Taiwan. Chemotherapy is commonly used in breast cancer treatment, but its associated toxicities, including nausea, vomiting, alopecia, fatigue, tissue toxicity, and immunosuppression, may negatively affect treatment tolerance and quality of life. Biobran is a rice bran arabinoxylan compound that has been reported to possess immunomodulatory, antioxidant, anti-inflammatory, and anti-tumor properties, and may help reduce chemotherapy- and radiotherapy-related side effects. However, evidence regarding its supportive role during breast cancer chemotherapy remains limited. In this study, 96 patients with breast cancer will be recruited from China Medical University Hospital. Participants will receive 3 grams of Biobran daily during 24 weeks. Outcomes will include chemotherapy-related side effects, quality of life, tumor size, tumor antigens, and routine blood test results.

Study Type

Interventional

Enrollment (Estimated)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Taichung, Taiwan, 406040
        • Recruiting
        • China Medical University Hospital
        • Contact:
      • Taichung, Taiwan, 406040
        • Not yet recruiting
        • China Medical University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Chong-Kuei Lii, PhD
        • Sub-Investigator:
          • Liang-Chih Liu, MD, PhD
        • Sub-Investigator:
          • Yi-Chen Huang, PhD
        • Sub-Investigator:
          • Yao Chung Wu, MD
        • Sub-Investigator:
          • Chen-Teng Wu, MD
        • Sub-Investigator:
          • Chih-Hao Huang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Breast cancer stage I-III

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Placebo
3 g placebo per day for 24 weeks
Experimental: Biobran
3 g Biobran per day for 24 weeks
Dietary supplement: Biobran supplementation
3 g Biobran per day for 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in the mean quality of life score at 12 weeks
Time Frame: Baseline and at 6、12、18、24 weeks after chemotherapy
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2025

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

March 19, 2026

First Submitted That Met QC Criteria

March 25, 2026

First Posted (Actual)

March 31, 2026

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • /CMUH113-REC2-202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Patent apply

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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