NCT04710290

A Cohort Study of Beta-Glucan or Beta-Glucan Compound in Metastatic Cancers

Status unknown Phase 2, PHASE3 Last updated 25 January 2021

What this trial tests

Phase 2, PHASE3 trial testing Beta-Glucan in Metastatic Cancer in 90 participants. Status unknown.

Timeline

4 January 2018

Primary endpoint
31 December 2021

31 December 2021

Quick facts

Lead sponsor	E-DA Hospital
Phase	Phase 2, PHASE3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	90
Start date	4 January 2018
Primary completion	31 December 2021
Estimated completion	31 December 2021
Sites	1 location across Taiwan

Drugs / interventions tested

• Beta-Glucan — full drug profile →
• Glutamine (GLUTAMINE) — full drug profile →
• Immunoglobuin
• Corn starch — full drug profile →

Conditions studied

• Metastatic Cancer — all drugs for Metastatic Cancer →
• Chemotherapy — all drugs for Chemotherapy →

Sponsor

E-DA Hospital

Who can join

20 and older, any sex, with Metastatic Cancer or Chemotherapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Immunity of cancer patients is an important issue. According to cancer immunity, it can be divided into three phases: clearance phase, equilibrium phase, and escape phase (cancer cells can avoid the recognition of immune cells). Βeta-glucans is extracted from yeast, it can increase immune function and drive of hematopoietic stem cells in animals and clinical trials. Glutamine can increase the repair of oral and intestinal mucosa of patients receiving chemical and radiation therapy and can increase the lymphocytes of patients. Colostrum contains IgA, IgG, IgM, etc., known to protect the baby Cancer patients who are infected with intestinal bacteria and undergo systemic chemotherapy are less immune than normal adults.

Investigators will compare β-glucan, glutamine, and colostrum immunoglobulin powder with β-glucan and control group, each group has 30 people, and observe the side effects and blood of patients under standard chemotherapy. The performance of the immune system, such as helpers and cytotoxic T cells and NK cells, and to observe the differences in treatment interruption or delay rates and treatment rates.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Amino acid metabolism in immune cells: essential regulators of the effector functions, and promising opportunities to enhance cancer immunotherapy.
   Yang L, Chu Z, Liu M, Zou Q, et al · · 2023 · cited 198× · PMID 37277776 · DOI 10.1186/s13045-023-01453-1
2. Tissue-Resident and Recruited Macrophages in Primary Tumor and Metastatic Microenvironments: Potential Targets in Cancer Therapy.
   Cotechini T, Atallah A, Grossman A. · · 2021 · cited 49× · PMID 33924237 · DOI 10.3390/cells10040960
3. Immunostimulatory Polymers as Adjuvants, Immunotherapies, and Delivery Systems.
   Weiss AM, Hossainy S, Rowan SJ, Hubbell JA, et al · · 2022 · cited 47× · PMID 36034324 · DOI 10.1021/acs.macromol.2c00854
4. From Cancer Therapy to Winemaking: The Molecular Structure and Applications of β-Glucans and β-1, 3-Glucanases.
   Caseiro C, Dias JNR, de Andrade Fontes CMG, Bule P. · · 2022 · cited 40× · PMID 35328577 · DOI 10.3390/ijms23063156
5. Harnessing myeloid cells in cancer.
   Park SY, Pylaeva E, Bhuria V, Gambardella AR, et al · · 2025 · cited 15× · PMID 40050933 · DOI 10.1186/s12943-025-02249-2