Safety and efficacy of 1,3/1,6 beta-glucans in breast cancer patients undergoing chemotherapy

A clinical safety and efficacy study of 1,3/1,6 beta-glucans in breast cancer patients undergoing chemotherapy

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20260604006

Enrollment

Registered

2026-06-04

Start date

2025-01-06

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

stage 2-4 breast cancer breast cancer beta-glucans neutropenia quality of life dietary supplement clinical trial

Interventions

dietary supplement containing 250 mg yeast beta-glucan (Thai FDA-approved product No. 13-1-18262-5-0009), one capsule per day for 21 days during the break between chemotherapy cycles ,dietary supplem

Experimental Dietary Supplement,Experimental Dietary Supplement,Placebo Comparator Dietary Supplement

yeast beta-glucan ,fungal beta-glucan ,placebo

Eligibility

Sex/Gender

Female

Age

20 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. female with stage 2 to 4 breast cancer, 2. 20 years old and above, 3. chemotherapy cycle 2 to 4, 4. Performance status ECOG 0 to 3, 5. Blood test before this cycle of chemotherapy, ANC at least 1,000 cells per mm(3), no more than grade 2 neutropenia, platelets at least 10(11) per L, Hemoglobin at least 9.0 g per dL, ALT at least 60 U per L, creatinine clearance using the CKD-EPI at least 50 mL per min

Exclusion criteria

Exclusion criteria: 1. GI, renal or liver diseases, 2. Immune-modulating, 3. diet supplements including beta-glucans, vitamin C, selenium, zinc, 4. allergy to yeast, fungi, mushroom, 5. fever (more than 38.3 degree Celsius or more than 38 degree Celsius for more than 1 h)

Design outcomes

Primary

Measure	Time frame
white blood cells 0, 21 days White Blood Cell count , Absolute Neutrophil Count,red blood cells 0, 21 days Hemoglobin, Hematocrit, Red Blood Cells Count	—

Secondary

Measure	Time frame
quality of life 0, 21 days The Functional Assessment of Cancer Therapy - Breast (FACT-B), The Functional Assessment of Cancer Therapy - Neutropenia (FACT-N),adverse symptoms 0, 21 days Common Terminology Criteria for Adverse Events (CTCAE), Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (Pro-CTCAE) ,liver function 0, 21 days Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) ,kidney function 0, 21 days Blood Urea Nitrogen (BUN), Creatinine	—

Measure

Time frame

quality of life 0, 21 days The Functional Assessment of Cancer Therapy - Breast (FACT-B), The Functional Assessment of Cancer Therapy - Neutropenia (FACT-N),adverse symptoms 0, 21 days Common Terminology Criteria for Adverse Events (CTCAE), Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (Pro-CTCAE) ,liver function 0, 21 days Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) ,kidney function 0, 21 days Blood Urea Nitrogen (BUN), Creatinine

—

Countries

Thailand

Contacts

Public ContactDunyaporn Trachootham

Institute of Nutrition, Mahidol University, Thailand

dunyaporn.tra@mahidol.ac.th66846953647

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026