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Researching Economical Adjuvants to Cancer Therapy

NCT ID: NCT07305259

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-12

Study Completion Date

2029-09-30

Brief Summary

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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

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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

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Healthy Participants

Keywords

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Beta-glucan exercise immune system cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Beta-glucan

375mg of beta-glucan is provided daily for 4 weeks.

Group Type EXPERIMENTAL

Beta-glucan

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

375mg of cellulose daily for 4 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

375mg of microcrystalline cellulose in capsule form.

Interventions

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Beta-glucan

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

375mg of microcrystalline cellulose in capsule form.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Florida State University

OTHER

Sponsor Role lead

Responsible Party

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Kyle Smith

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Institute of Sports Sciences and Medicine

Tallahassee, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kyle A Smith, PhD, RD

Role: CONTACT

Phone: 850-644-1016

Email: [email protected]

Facility Contacts

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Kyle A Smith, PhD, RD

Role: primary

Other Identifiers

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00005291

Identifier Type: -

Identifier Source: org_study_id