Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07305259

Researching Economical Adjuvants to Cancer Therapy

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Institute of Sports Sciences and Medicine

Tallahassee, Florida, 32306, United States

Location status: Recruiting

Location contact

Kyle A Smith, PhD, RD

CONTACT

[email protected]

8506451016

Kyle A Smith, PhD, RD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

beta-glucan

Dietary Supplement

375mg of beta-glucan in the form of a ground mushroom powder. The supplement is provided in capsule form.

Placebo

Dietary Supplement

375mg of microcrystalline cellulose in capsule form.

Primary outcomes

  1. Cellular Cytotoxicity Assessed With Flow Cytometry

    Time frame: At baseline, the end of treatment at four weeks, and at eight weeks after a washout phase.

    The ability of participant peripheral blood mononuclear cells (PBMCs) to kill target cancers cells in vitro. PBMCs will be co-cultured with cancer cells for four hours, and the number of cancer cells killed over time will be quantified with flow cytometry (e.g., CD71+ labeled cancer cells with compromised cell membranes).

Study contacts

Contact information is provided by the study sponsor or research team.

Kyle A Smith, PhD, RD

CONTACT

[email protected]

850-644-1016

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Registry information

Acronym: REACT

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Dec 26, 2025
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.