Researching Economical Adjuvants to Cancer Therapy
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Cellular Cytotoxicity Assessed With Flow Cytometry
研究概览
简要总结
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:
- Does beta-glucan change the ability of immune cells to recognize cancer cells?
- 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:
- Take beta-glucan or a placebo daily for 4 weeks.
- Visit the laboratory for three exercise tests.
- Provide blood samples so researchers can study immune system cells.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Physically fit enough to engage in maximal exercise.
排除标准
- •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
结局指标
主要结局
Cellular Cytotoxicity Assessed With Flow Cytometry
时间窗: 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).
次要结局
未报告次要终点
研究者
Kyle Smith
Assistant Professor
Florida State University