Researching Economical Adjuvants to Cancer Therapy

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка Beta-glucan
  375mg of beta-glucan in the form of a ground mushroom powder. The supplement is provided in capsule form.
• Пищевая добавка Placebo
  375mg of microcrystalline cellulose in capsule form.

Первичные конечные точки

• Cellular Cytotoxicity Assessed With Flow Cytometry [Срок оценки: At baseline, the end of treatment at four weeks, and at eight weeks after a washout phase.]

Критерии участия

Критерии включения

• Physically fit enough to engage in maximal exercise.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• Institute of Sports Sciences and Medicine — Tallahassee

Идентификаторы

NCT: NCT07305259 · 00005291

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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