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Recruiting NCT07503496

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

No phase Interventional Breast Cancer Stages I Breast Cancer Stages II Breast Cancer Stage III

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biobran supplementation.
Who it may be relevant to
Registry conditions: Breast Cancer Stages I, Breast Cancer Stages II, Breast Cancer Stage III. Basic parameters: 20 years — 65 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Dietary supplement Biobran supplementation
    3 g Biobran per day for 24 weeks

Primary outcome measures

  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Supportive care

Study locations

Taiwan · 2 centers
  • China Medical University Hospital — Taichung
  • China Medical University — Taichung

Identifiers

NCT: NCT07503496 · /CMUH113-REC2-202

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗