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
干预措施
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
- •DISEASE CHARACTERISTICS:
- •Current diagnosis of cancer that supports the use of continuous definitive or adjuvant external-beam radiotherapy (RT) to the pelvis to a minimum dose of 4,500 cGy with the following parameters:
- •The pelvis must be encompassed by the planned RT fields
- •The superior border may not lie inferior to the most inferior aspect of the sacroiliac joints
- •Portions of the rectum may have special blocking, depending upon disease site
- •The total prescription dose must lie between 4,500-5,350 cGy (inclusive)
- •A boost to primary tumor or tumor bed may be planned
- •Planned treatment is to be given 4-5 times per week on a one- treatment-per-day basis
- •The daily prescribed dose must lie between 170-210 cGy (inclusive) per day
- •No planned split-course RT
- •No proton RT
- •Will receive concurrent administration of chemotherapy (fluorouracil, capecitabine, cisplatin, oxaliplatin, carboplatin, and/or mitomycin C) during pelvic RT
- •No current or prior metastases beyond regional lymph nodes
- •PATIENT CHARACTERISTICS:
- •ECOG performance status (PS) of 0, 1, or 2
- •Life expectancy ≥ 6 months
- •Able to complete questionnaire(s) by themselves or with assistance
- •Not pregnant or nursing
- •Negative pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only
- •Fertile patients must use effective contraception
- •Hemoglobin > 10.0 g/dL
- •White blood cells (WBC) > 3,500/mm³
- •Absolute neutrophil count (ANC) > 1,500/mm³
- •Platelet count > 100,000/mm³
- •Willing to abstain from ingestion of yogurt products and/or any product containing probiotics during study drug treatment
- •No known allergy to a probiotic preparation
- •No history of inflammatory bowel disease
- •No ≥ grade 3 diarrhea, ≥ grade 3 rectal bleeding, abdominal cramping, or incontinence of stool ≤ 7 days prior to registration
- •No medical condition that may interfere with ability to receive protocol treatment
- •No history of gastrointestinal or genitourinary obstruction or porphyria
- •No history of irritable bowel syndrome (IBS)
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No prior abdominal-perineal resection, Hartmann procedure, or other surgical procedure leaving the patient without a functioning rectum
- •No planned use of leucovorin
- •No prior pelvic RT
- •No use of probiotics ≤ 2 weeks prior to registration
- •No use of antibiotics ≤ 3 days prior to registration
- •No planned continuous antibiotic treatment during RT
排除标准
- 未提供
研究组 & 干预措施
Arm I
Experimental
Patients receive live freeze-dried lactic acid bacteria probiotic (VSL#3®) orally (PO) 3 times a day during RT (5-8 weeks) and for 2 weeks after completion of RT.
干预措施: live freeze-dried lactic acid bacteria probiotic (Dietary Supplement)
Arm II
Placebo Comparator
Patients receive placebo PO 3 times a day during RT (5-8 weeks) and for 2 weeks after completion of RT.
干预措施: placebo (Other)
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
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