Using an inexpensive supplement and exercise to boost cancer-fighting immune cells
Researching Economical Adjuvants to Cancer Therapy
Researchers will test whether taking daily beta-glucan for four weeks, with or without a single bout of exercise, helps healthy adults' immune cells recognize cancer cells better.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Florida State University Academic / other |
| Drugs / interventions | ipilimumab, pembrolizumab, monalizumab, immunotherapy |
| Locations | 1 site (Tallahassee, Florida) |
| Trial ID | NCT07305259 on ClinicalTrials.gov |
What this trial studies
This randomized, placebo-controlled early-phase trial gives healthy adults daily beta-glucan or a matching placebo for four weeks and includes three laboratory exercise sessions with blood sampling. Investigators will analyze how immune cells interact with cancer targets at the receptor-ligand level and measure changes in immune cell populations after acute exercise. The protocol includes laboratory assessments of how these changes might affect responses to existing immunotherapies such as ipilimumab and pembrolizumab, using ex vivo assays rather than administering those drugs to participants. The focus is mechanistic: to see whether a low-cost dietary adjuvant plus exercise can meaningfully change immune behavior relevant to cancer therapy.
Who should consider this trial
Good fit: Healthy adults who can safely perform maximal exercise, are not taking medications or having conditions that affect immune function, and can attend in-person visits would be ideal candidates.
Not a fit: People with diabetes, autoimmune or overt cardiovascular/respiratory/neurological disease, recent tobacco use, pregnancy, or those on immune-modulating medications would likely be excluded and not expected to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could provide a low-cost way to strengthen immune responses against cancer and potentially improve how well immunotherapies work.
How similar studies have performed: Prior work shows beta-glucan and acute exercise can each boost certain immune markers, but combining them to enhance cancer-targeting immune responses is largely novel and not yet proven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Physically fit enough to engage in maximal exercise. Exclusion Criteria: * BMI \> 40 kg/m2 * Stage 2 hypertension (140/90 mmHg) * Type I or II diabetes * Autoimmune diseases * Overt cardiovascular, respiratory, or neurological disease (e.g., previous heart attack, pacemaker, heart failure, asthma) * Hormone replacement therapy (e.g., androgens, estrogens) * Daily medication usage that may affect immune function (e.g., beta blockers, NSAIDs, corticosteroids, allergy medications) * Current antibiotic use * Heavy alcohol usage (\>2 drinks per day) * Tobacco use within the last 6 months * Adults unable to consent * Individuals who are not yet adults (infants, children, teenagers) * Self-reported pregnancy * Prisoners
Where this trial is running
Tallahassee, Florida
- Institute of Sports Sciences and Medicine — Tallahassee, Florida, United States (Recruiting)
Study contacts
- Study coordinator: Kyle A Smith, PhD, RD
- Email: k.smith@fsu.edu
- Phone: 850-644-1016
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.