Breast Cancer Stage III, Breast Cancer Stages I, Breast Cancer Stages II
Conditions
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.
Interventions
DIETARY_SUPPLEMENTBiobran supplementation
3 g Biobran per day for 24 weeks
Sponsors
China Medical University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the mean quality of life score at 12 weeks | 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. |
Countries
Taiwan
Contacts
CONTACTChong-Kuei Lii, PhD
CONTACTYi-Chen Huang, PhD
Outcome results
None listed