Breast Cancer Stages INCT07503496
Evaluation of the Efficacy of Biobran (Rice Bran Arabinoxylan) in Supporting Breast Cancer Chemotherapy
A study testing Biobran supplementation in people with Breast Cancer Stages I and Breast Cancer Stages II, run by China Medical University Hospital at 2 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Breast Cancer Stages I, Breast Cancer Stages II, Breast Cancer Stage III
- What is being tested?
- Biobran supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 2 sitesTaiwan
- Study dates
- 7 Apr 2025to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breast cancer stage I-III
Who cannot join
- pregnant, lactation, breast recurrence, mental disease, autoimmune disease over hte past 5 years, people who take plant or fungal polysaccharide health supplements
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan2 sites, 2 recruiting
- Recruiting
China Medical University Hospital
Taichung, 406040
Chong Kuei Lii, 886-222053366, cklii@mail.cmu.edu.tw
- Not yet recruiting
China Medical University
Taichung, 406040
Chong-Kuei Lii, PhD, 886916226551, cklii@mail.cmu.edu.tw
Liang-Chih Liu, MD, PhD, 886422052121 ext. 11639, 007495@tool.caaumed.org.tw
About this study
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.
Read the 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.
- Being tested
- Biobran supplementation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biobran supplementationDietary supplement
3 g Biobran per day for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | No intervention | 3 g placebo per day for 24 weeks |
| Biobran | Experimental | 3 g Biobran per day for 24 weeks Receives: Dietary Supplement: Biobran supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and at 6、12、18、24 weeks after chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start7 Apr 2025
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Stages IStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07503496
- Sponsor's protocol ID
- /CMUH113-REC2-202
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2026
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patent apply
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Biobran (Rice Bran Arabinoxylan) in Supporting Breast Cancer Chemotherapy
- ClinicalTrials.gov ID
- NCT07503496
- Acronym / sponsor ID
- /CMUH113-REC2-202
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 7 Apr 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 31 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | No intervention | –3 g placebo per day for 24 weeks |
| Biobran | Experimental | Dietary Supplement: Biobran supplementation3 g Biobran per day for 24 weeks |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Breast cancer stage I-III
Key exclusion criteria (1 listed)
- pregnant, lactation, breast recurrence, mental disease, autoimmune disease over hte past 5 years, people who take plant or fungal polysaccharide health supplements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biobran supplementation3 g Biobran per day for 24 weeks | Dietary supplement | Biobran |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Individual participant dataSharing planned: No. Patent apply
Related trials for Breast Cancer Stages I
Not yet recruiting
Mind-Body Interventions for the Improvement of Quality of Life, Stress, and Sleep Quality Among Survivors of Breast, Prostate, Endometrial, or Colorectal Cancer
Breast Cancer Stage I, Colorectal Cancer
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
RecruitingPhase 2
Dose-Reduced Docetaxel With Cyclophosphamide for the Treatment of Vulnerable Older Women With Stage I-III HER2 Negative Breast Cancer, the DOROTHY Trial
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8
RecruitingPhase 2
Ph2 Study for Optimization of Adjunct Systemic Therapy in HER2+ Patients, MolecularPCR Trial
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8
Recruiting
Researching the Effect of Exercise on Cancer
Breast Cancer, Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biobran supplementation in people with Breast Cancer Stages I and Breast Cancer Stages II, run by China Medical University Hospital at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chong-Kuei Lii, PhD (+886916226551, cklii@mail.cmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.