NCT01473290撤回3 期
A Phase III, Randomized, Double-Blind Placebo Controlled Study of the Probiotic Preparation VSL#3® Versus Placebo in the Prevention of Acute Enteritis in Patients Receiving Concurrent Chemotherapy and Pelvic Radiation Therapy
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Average area under the curve (AUC) of the FACIT-D diarrhea subscale score assessed weekly during treatment and for two weeks following the completion of RT
研究概览
简要总结
RATIONALE: Probiotic therapy may reduce or prevent gastrointestinal complications in patients undergoing chemotherapy and pelvic radiation therapy.
PURPOSE: This randomized phase III trial is studying how well probiotic therapy works in preventing gastrointestinal complications in patients undergoing chemotherapy and pelvic radiation therapy.
详细描述
OBJECTIVES:
Primary
- To determine whether live freeze-dried lactic acid bacteria probiotic (VSL#3®) is effective in reducing the acute treatment-related bowel function disturbances, as measured by the FACIT-D diarrhea subscale score in patients receiving concurrent chemotherapy and pelvic RT as adjuvant or primary treatment for malignancy.
Secondary
- To determine whether VSL#3® can reduce chronic treatment-related bowel dysfunction following completion of therapy.
- To examine whether VSL#3® appears to have an impact on disease-free survival.
- To bank blood products for future studies. (exploratory)
- To characterize changes in the fecal microbiota and examine for correlation with treatment assignment and symptom scores. (exploratory)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Average area under the curve (AUC) of the FACIT-D diarrhea subscale score assessed weekly during treatment and for two weeks following the completion of RT
时间窗: Up to 12 months
次要结局
- Bowel function measures as assessed by the clinician using the CTCAE version 4 and as assessed by the PBFQ and the PRO-CTCAE(Up to 12 months)
- Psychometric evaluation of the reliability and validity of the FACIT-D diarrhea subscale, PBFQ, and PRO-CTCAE(Up to 12 months)
- Disease-free survival(Up to 12 months)
研究者
相似试验
Unknown
不适用
Effects of Probiotics Supplementation on Intestinal Microbiome in Malignancy Pts(Get Pelvic/Abdominal Rtx)CancerNCT01706393Seoul National University Hospital26
已完成
3 期
Probiotics-prebiotic Fiber Therapy in Parkinson's Disease Patients With ConstipationParkinson DiseaseConstipationNCT04451096National University of Malaysia48
已完成
不适用
Intervention Study to Evaluate a Probiotic in Mild to Moderate Psoriasis PatientsPsoriasisNCT02576197Biopolis S.L.98
已完成
不适用
A Probiotic Blend Reduces Gastrointestinal Symptoms and Positively Impacts Microbiota Modulation in a Randomized StudyMicrobiotaCandidaConstipationNCT05614726The Center for Applied Health Sciences, LLC52
尚未招募
不适用
A Study on Probiotic Formula in Autistic ChildrenAutism Spectrum DisorderNCT06419530Third Military Medical University156