Researching Economical Adjuvants to Cancer Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Beta-glucan, Placebo.
- Who it may be relevant to
- Registry conditions: Healthy Participants. Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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.
Primary outcome measures
- 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.]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Institute of Sports Sciences and Medicine — Tallahassee
Identifiers
NCT: NCT07305259 · 00005291