Intestinal Microbiome Profiles in Women With Gynecological Tumors and Pelvic Toxicity Secondary to Radiotherapy and Chemotherapy: Comparison With Controls and Effect of Rectal Ozone Treatment.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Comparison of gut microbiome profile (composition and diversity) between TPIRQT and Control groups
研究概览
简要总结
Patients treated for gynecological tumors with radiotherapy (RT) and/or chemotherapy (CT) frequently develop pelvic toxicity (TPIRQT), a condition that can become persistent, progressive, and refractory to standard treatments. This toxicity, affecting the rectum (proctitis), bladder (cystitis), and vagina (mucositis), severely deteriorates quality of life. Standard options for refractory cases are limited; at our center, rectal ozone therapy is used with high rates of symptomatic improvement (66-75%). Emerging evidence suggests a link between gut microbiota and the development of TPIRQT. However, it is unknown how rectal ozone therapy may influence the gut microbiome or if this modulation is part of its therapeutic mechanism. This prospective observational study will investigate the potential relationship between gut microbiome profiles (composition and diversity), the presence and severity of TPIRQT, and the response to rectal ozone therapy.
详细描述
Patients treated for gynecological tumors with radiotherapy (RT) and/or chemotherapy (CT) frequently develop pelvic toxicity (TPIRQT), a condition that can become persistent, progressive, and refractory to standard treatments. This toxicity, affecting the rectum (proctitis), bladder (cystitis), and vagina (mucositis), severely deteriorates quality of life. Standard options for refractory cases are limited; at our center, rectal ozone therapy is used with high rates of symptomatic improvement (66-75%). Emerging evidence suggests a link between gut microbiota and the development of TPIRQT. However, it is unknown how rectal ozone therapy may influence the gut microbiome or if this modulation is part of its therapeutic mechanism. This prospective observational study will investigate the potential relationship between gut microbiome profiles (composition and diversity), the presence and severity of TPIRQT, and the response to rectal ozone therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Comparison of gut microbiome profile (composition and diversity) between TPIRQT and Control groups
时间窗: Baseline (single time point for controls, pre-ozone for cases)
Gut microbiome composition and diversity (from a single sample) in control patients will be compared to the baseline profile of patients with TPIRQT.
Change in gut microbiome profile (composition and diversity) in patients with TPIRQT after rectal ozone therapy.
时间窗: Baseline (pre-ozone therapy) , 4 Months (post-ozone therapy)
Gut microbiome composition and diversity will be analyzed from stool samples using 16S ribosomal RNA gene sequencing.
Correlation of gut microbiome profile with grade of pelvic toxicity.
时间窗: Baseline (for Control group); Baseline, 4 Months (for TPIRQT group).
Toxicity will be assessed using: i) the CTCAE v.5.0 scale from the NCI , and ii) the EORTC QLQ-CX24 questionnaire. This will be evaluated for its relationship to microbiome data.
次要结局
- Correlation of gut microbiome profile with health-related quality of life (HRQoL).(Baseline (for Control group); Baseline, 4 Months (for TPIRQT group).)
- Correlation of gut microbiome profile with anxiety and depression levels.(Baseline (for Control group); Baseline, 4 Months (for TPIRQT group).)
- Correlation of gut microbiome profile with biochemical markers of oxidative stress and inflammation.(Baseline (for Control group); Baseline, 4 Months (for TPIRQT group).)
研究者
Bernardino Clavo, MD, PhD
Principal Investigator, Research Unit Director
Dr. Negrin University Hospital