A Phase II Feasibility and Correlative Study of Probiotic Supplementation in Cancer Patients Receiving Chemotherapy or Tyrosine Kinase Inhibitors (TKIs)
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Incidence of grade 2-4 diarrhea over the 9-week study period, assessed by CTCAE version 4.0
研究概览
简要总结
This randomized phase II clinical trial studies probiotic supplementation in preventing treatment-related diarrhea in patients with cancer undergoing chemotherapy. Probiotics may help prevent diarrhea caused by treatment with chemotherapy.
详细描述
PRIMARY OBJECTIVES:
I. Incidence of moderate/severe (grade 2-4) diarrhea graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
II. Functional Assessment of Chronic Illness Therapy - Diarrhea (FACIT-D) Trial Outcome Index.
SECONDARY OBJECTIVES:
I. To evaluate the effects of probiotic supplementation on dose delays or reductions due to gastrointestinal (GI) toxicity.
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
- •Any patient with a documented malignancy initiating treatment including (as a single agent or in combination with other drugs) any one of the following cancer therapeutics:
- •o Fluorouracil (5FU), capecitabine, irinotecan, paclitaxel, docetaxel, cabazitaxel, crizotinib, sorafenib, sunitinib, erlotinib, or lapatinib
- •Any pathologically confirmed malignancy for which the patient would receive any of the listed cancer therapeutics
- •Performance status of Eastern Cooperative Oncology Group (ECOG) 0-2
- •Patient must have an estimated life expectancy of at least 6 months
- •Absolute neutrophil count (ANC) > 1500
- •Platelets > 100K
- •Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 2.5 x ULN (upper limit normal)
- •Serum bilirubin < 1.5 x ULN
- •Serum creatinine < 1.5 x ULN
- •Ability to understand and the willingness to sign a written informed consent document and comply with the treatment protocol
排除标准
- •Patients currently undergoing treatment with the above listed therapeutics at time of initiation of trial; patients can have had prior treatment(s) with one or more of the agents if they are initiating a new treatment with another agent on the list, provided they have had at least a 2 week "washout" period
- •Patients currently taking anti-diarrheal medications or therapy
- •Patients undergoing hemodialysis
- •Patients with known allergic or hypersensitivity reaction to probiotics, yoghurt, or similar diet or supplemental products
- •Acute or chronic diarrhea, including lactose intolerance, gluten or other dietary sensitivity resulting in gastrointestinal symptoms
- •Pregnant or nursing patients
- •Known human immunodeficiency virus (HIV) positive
- •Prior abdominal surgery resulting in a stoma, ostomy, fistula, or other anatomic defect
- •Concurrent or near future radiotherapy; prior, completed radiotherapy allowed; any radiotherapy within the vicinity of the GI tract must have been completed at least 4 weeks prior to start of trial
- •Treatment with any investigational drug within 4 weeks prior to enrollment
- •Current treatment with antibiotics or other gut motility agents within 2 weeks of starting study medication
- •Abnormal thyroid function that is not controlled with medication
- •Patients taking other dietary supplements within 2 weeks of starting study medication
- •Any other serious or uncontrolled illness which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial
结局指标
主要结局
Incidence of grade 2-4 diarrhea over the 9-week study period, assessed by CTCAE version 4.0
时间窗: Up to 9 weeks
Will be calculated by the percentage of patients experiencing grade 2-4 diarrhea as documented by patient diary and primary oncologist's documentation. The data for patients on tyrosine kinase inhibitors and conventional cytotoxic chemotherapy will be analyzed both combined and separately.
FACIT-D Trial Outcome Index (TOI)
时间窗: Up to 4 weeks post treatment
The FACIT-D TOI has a range of scores from 0-100 which are a combination of physical well being, functional well being, and diarrhea subscale. The data for patients on tyrosine kinase inhibitors and conventional cytotoxic chemotherapy will be analyzed both combined and separately.
次要结局
- Overall survival(Up to 2 years)
- Dose delays or reductions due to GI toxicity(Up to 9 weeks)
- Anti-diarrheal use(Up to 9 weeks)
- Overall HR-QOL(Up to 4 weeks post treatment)
- Febrile neutropenia(Up to 4 weeks post treatment)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(Up to 4 weeks post treatment)
- Progression free survival(Up to 2 years)