Evaluation of the Efficacy of Biobran (Rice Bran Arabinox... | NCT07503496

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

NCT07503496

Sponsor

China Medical University Hospital

Status

Recruiting

Last Update Posted

Mar 31, 2026Actual

Enrollment

96Estimated

Phase

Not Applicable

Conditions

Breast Cancer Stages I
Breast Cancer Stages II
Breast Cancer Stage III

Interventions

Biobran supplementation

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 7, 2025Actual

Primary Completion Date

Aug 31, 2026Estimated

Completion Date

Aug 31, 2026Estimated

First Submitted Date

Mar 19, 2026

First Submission Date that Met QC Criteria

Mar 25, 2026

First Posted Date

Mar 31, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2026

Last Update Posted Date

Mar 31, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

96Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Biobran supplementation	Dietary Supplement	3 g Biobran per day for 24 weeks	Biobran

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chong-Kuei Lii, PhD	Contact	+886916226551		cklii@mail.cmu.edu.tw
Yi-Chen Huang, PhD	Contact	886915754860		yichenhuang@mail.cmu.edu.tw

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
China Medical University Hospital	Recruiting	Taichung		406040	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

Patent apply

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided