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
- 招募中
- 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
- •for all patients (Cases and Controls):
- •Adult women (>=18 years).
- •Diagnosed with gynecological tumors (any location and stage).
- •Previously treated with radiotherapy and/or chemotherapy.
- •Must accept and sign the specific informed consent for this study.
- •Additional Inclusion Criteria for inclusion in the TPIRQT Group (Cases):
- •Must present chronic TPIRQT with >= 3 months of duration after habitual symptomatic treatment.
- •Must have a toxicity Grade of 2 (moderate symptoms, limiting instrumental ADL) or higher, according to the CTCAE v.5.0 scale.
排除标准
- •for all patients (Cases and Controls):
- •Not meeting all inclusion criteria.
- •Presence of active inflammatory bowel disease (e.g., Crohn's Disease, Ulcerative Colitis) or a history of major gastrointestinal resection (excluding appendectomy) that could significantly alter gut anatomy and microbiota.
- •Any uncontrolled intercurrent illness or psychiatric condition that, in the investigator's opinion, would limit compliance with study requirements or interfere with the interpretation of results.
- •Unwillingness or inability to provide written informed consent for study participation.
研究组 & 干预措施
TPIRQT Group (Cases)
Patients with gynecological tumors treated with RT and/or CT who develop chronic pelvic toxicity (TPIRQT) and are referred for compassionate-use rectal ozone therapy at the Chronic Pain Unit. Samples and data will be collected before and after ozone therapy
Control Group
pelvic toxicity (TPIRQT). This group will be matched by age (± 5 years) and primary tumor location. Samples and data will be collected once during a follow-up visit.
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
Hospital Universitario de Gran Canaria Doctor Negrín