Safety of Oral Activated Charcoal and Its Effect on the Gut Microbiome In Patients With Lung Cancer Undergoing Transcervical Extended Mediastinal Lymphadenectomy (TEMLA)
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Number of patients who are free from analgesics within 3 days of TEMLA
研究概览
简要总结
This proof-of-concept study serves as the preliminary step to prove safety of oral activated charcoal (OAC) in patients with solid tumors before moving to a hematologic malignancy patient population.
详细描述
TEMLA (Transcervical Extended Mediastinal Lymphadenectomy) is a procedure for mediastinal lymph node sampling to stage patients with lung cancer. All patients receive a dose of IV antibiotic pre-procedure to prevent infection. The concept of the proposed study is to protect the gut microbiome against detrimental effects of the antibiotic using oral activated charcoal as a potent adsorbent with no absorption. Oral activated charcoal (OAC) binds to the fraction of IV antibiotic that reaches the lumen of the gut without interfering with its desired systemic effects. The conceptual goal is to prevent dysbiosis by protecting the gut microbiome. Dysbiosis is the leading cause of C. difficile infection and a number of other adverse clinical outcomes such as antibiotic resistance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suspected or confirmed diagnosis of lung cancer (non-small cell lung cancer, small-cell lung cancer or neuroendocrine tumor) for which a standard of care Transcervical Extended Mediastinal Lymphadenectomy (TEMLA) is planned
- •Planned pre-procedural IV antibiotic. The choice of antibiotic type is up to the treatment physician(s)
- •Able to safely hold all oral medications on the day of surgery and the day after to ensure the absorption of such drugs is not affected due to charcoal ingestion the night before surgery
- •18 years of age or older
- •Able to provide written consent prior to any research related activities
排除标准
- •Current pregnancy or breastfeeding (SOC pre-TEMLA testing/assessment)
- •Any current diagnosed disease with known involvement of the gastrointestinal tract
- •Known allergy to oral activated charcoal
- •CTCAE v 5 Dysphagia Grade 2 (symptomatic and altered eating/swallowing) or greater
- •Known risk of aspiration based on history or current complaints
- •Gastrointestinal procedures within 2 weeks before or (planned) after TEMLA
- •Systemic antibiotic use within 8 weeks before planned TEMLA
研究组 & 干预措施
Adults undergoing TEMLA
Adults undergoing TEMLA (Transcervical Extended Mediastinal Lymphadenectomy) take Oral Activated Charcoal (OAC) dissolved in apple juice a night before the surgery
干预措施: Activated charcoal (Drug)
结局指标
主要结局
Number of patients who are free from analgesics within 3 days of TEMLA
时间窗: 3 days after surgery
The duration of analgesic medication use after a standard of care Transcervical Extended Mediastinal Lymphadenectomy (TEMLA) is observed and the number of patients who are free from analgesics is reported
次要结局
- Number of patients with C. difficile infection(4 weeks after surgery)
- Characterization of changes in microbiome composition(pre-surgery and through study completion , 21-35 days after surgery)
- Number of patients experiencing gastrointestinal adverse events(5 days after surgery)
- Characterization of changes in microbiome diversity(pre-surgery and through study completion, 21-35 days after surgery)