NCT07305259

Researching Economical Adjuvants to Cancer Therapy

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Florida State University · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to learn if beta-glucan (a dietary fiber) improves the function of the immune system in adults. It will also tell the investigators if combining beta-glucan with single bouts of exercise provides additional benefit. The main questions it aims to answer are: 1. Does beta-glucan change the ability of immune cells to recognize cancer cells? 2. Does exercise change the type of immune cells in the blood? Researchers will compare beta-glucan to a placebo (a look-alike substance with no effect) to see if beta-glucan could improve immune function against cancer. Participants will: 1. Take beta-glucan or a placebo daily for 4 weeks. 2. Visit the laboratory for three exercise tests. 3. Provide blood samples so researchers can study immune system cells.

Detailed description

This investigation is a randomized, placebo-controlled trial seeking to determine the extent to which acute exercise and dietary β-glucan supplementation can augment immune responses against cancer. The investigators will mechanistically determine the receptor-ligand interactions between effector lymphocytes and target cancer cells, as well as assess multiple immunotherapies alongside the intervention (e.g., ipilimumab, pembrolizumab, monalizumab). Incorporating lifestyle medicine is well known to improve patient quality of life, and early evidence suggests it may favorably impact overall survival. It is crucial that the investigators harness the immunological potential of lifestyle interventions to broadly improve immunotherapy effectiveness.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Beta-glucan	375mg of beta-glucan in the form of a ground mushroom powder. The supplement is provided in capsule form.
DIETARY_SUPPLEMENT	Placebo	375mg of microcrystalline cellulose in capsule form.

Timeline

• Start date: 2025-11-12
• Primary completion: 2029-09-30
• Completion: 2029-09-30
• First posted: 2025-12-26
• Last updated: 2025-12-26

Locations

1 site across 1 country: United States