A Phase I and Randomized Controlled Phase II Trial of the Probiotic LGG for Prevention of Side Effects in Patients Undergoing Chemoradiation for Gastrointestinal Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Efficacy (randomized phase II trial)
研究概览
简要总结
Phase 3 placebo-controlled trial to determine efficacy of the probiotic LGG for reducing acute treatment related GI toxicity in patients with GI malignancy with phase 1 safety lead-in.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Current diagnosis of a gastrointestinal, abdominal, or pelvic cancer for which the use of continuous definitive or adjuvant external-beam RT to the abdomen or pelvis to a minimum dose of 4500 cGy is planned.
- •Scheduled to receive concurrent administration of fluoropyrimidine chemotherapy (5-FU or capecitabine) during radiation therapy.
- •Age ≥ 18 years.
- •Life expectancy ≥ 6 months.
- •Negative pregnancy test done ≤7 days prior to registration (for women of childbearing potential only).
- •The following laboratory values obtained ≤ 28 days prior to registration:
- •Hemoglobin ≥ 9.0 g/dL
- •WBC ≥ 3,500
- •Absolute neutrophil count ≥ 1,500
- •Platelets ≥ 100,000
- •ECOG Performance Status (PS) of 0, 1, or
- •Willingness to abstain from ingestion of yogurt products and/or any product containing probiotics during study drug treatment.
- •Ability to complete questionnaire(s) alone or with assistance.
- •Ability to understand and willingness to sign informed consent.
排除标准
- •Previous bowel resection which, in the opinion of the investigator, would decrease the benefit of the probiotic. Patients who have undergone recent bowel surgeries which would not decrease the benefit of the probiotic are eligible provided they are more than 30 days from surgery with no serious complications.
- •Known allergy to a probiotic preparation.
- •Any history of inflammatory bowel disease.
- •Grade 3 or 4 diarrhea, rectal bleeding, abdominal cramping, or incontinence of stool ≤7 days prior to registration.
- •Any medical condition that may interfere with ability to receive protocol treatment.
- •Prior abdominal or pelvic RT.
- •Use of probiotics ≤ 2 weeks prior to registration.
- •Use of antibiotics ≤ 3 days prior to registration.
- •Planned continuous antibiotic treatment during RT.
- •History of gastrointestinal or genitourinary obstruction or porphyria.
- •History of irritable bowel syndrome (IBS).
- •History of hypersensitivity to all of the following antibiotics: penicillin, erythromycin, clindamycin, and any fluoroquinolone.
研究组 & 干预措施
LGG
LGG (containing 10^10 viable bacteria) taken by mouth twice daily beginning at baseline (but starting at least 3 days prior to the start of radiation) and continue during RT and for the 2 weeks following RT.
干预措施: LGG (Drug)
Placebo
Placebo taken by mouth twice daily beginning at baseline (but starting at least 3 days prior to the start of radiation) and continue during RT and for the 2 weeks following RT.
干预措施: Placebo (Drug)
结局指标
主要结局
Efficacy (randomized phase II trial)
时间窗: Up to 6 months following the last dose of LGG or placebo
Compare the proportion of patients receiving abdominal or pelvic chemoradiation with a fluoropyrimidine being treated with the probiotic LGG who develop CTCAE grade 2 or greater diarrhea to the proportion of patients receiving abdominal or pelvic chemoradiation with a fluoropyrimidine being treated with placebo who develop CTCAE grade 2 or greater diarrhea
Safety (phase I safety lead-in)
时间窗: Up to 30 days following completion of treatment
Determine the safety and tolerability of LGG in patients receiving abdominal or pelvic chemoradiation with a fluoropyrimidine The DSMC will review the data as part of an interim analysis when the last patient has had 30 days of follow-up. The DSMC will ensure that at least 18 patients have had follow-up at 30 days (with expected 10% drop-out). Accrual to the randomized portion of the trial will occur only if there are no episodes of lactobacillus associated septicemia. Additionally, if two or more serious adverse events of a similar nature occur and a causal relationship to the investigational product cannot be excluded, accrual to the randomized portion will not occur.
次要结局
- Diarrhea subscale score(Up to 5 years after completion of treatment.)
- Need for antidiarrhea medication(Up to 2 weeks after completion of treatment)
- Grade 3 or greater diarrhea(Up to 6 months following the last dose of LGG or placebo)
- Fecal calprotectin(Up to 2 weeks following the completion of treatment)
- Serum citrulline(Up to 2 weeks following the completion of treatment)