MC1267, A Randomized, Blinded Pilot Placebo-Controlled Trial With Oral Serum Bovine Immunoglobulin (SBI) to Assess Quality of Life and the Faster Post-Operative Recovery of Gynecological Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Time-to-QOL Improvement Defined as Any Increase in the QOL Score Measured Using the Total Score of the 14-item Postoperative Quality of Life (PQL) Tool
研究概览
简要总结
This randomized pilot phase II trial studies how well serum bovine immunoglobulin protein isolate works in improving quality of life and post-operative recovery in patients with cancer of the female reproductive tract after undergoing surgery. Serum bovine immunoglobulin may help provide nutrition to patients who are not able to eat or digest ordinary food. This may improve the quality of life of patients with gynecological cancer and help them recover more quickly from surgery.
详细描述
PRIMARY OBJECTIVES:
I. To compare the time-to-quality of life (QOL) improvement from baseline in postoperative gynecological cancer patients who are receiving oral serum bovine immunoglobulin (SBI) vs. placebo.
SECONDARY OBJECTIVES:
I. To compare the surgical complication rates between oral SBI vs. placebo up to 1 month post-surgery (safety endpoint).
II. To compare the QOL, as derived from the previously-validated Symptom Distress Scale, the Postoperative Quality of Life questionnaire (PQL), and the uniscale (overall QOL item) between patients receiving oral SBI vs. placebo.
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 (Participant, Investigator)
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
- •Diagnosis of gynecological cancer of any type or strong suspicion for cancer
- •Patients must have begun postoperative oral intake of food prior to registration
- •Open laparotomy or laparoscopic surgery undertaken with cancer therapeutic intent (not a subsequent surgery to manage a postoperative complication) that had occurred =< 7 days prior to registration and that entailed more than a simple hysterectomy
- •Creatinine =< 1.5 x the upper limit of normal (ULN)
- •Absolute neutrophil count >= 1500/mm^3
- •Platelet count >= 100,000/mm^3
- •Ability to complete questionnaire(s) by themselves or with assistance
- •Provide informed written consent
- •Negative (serum) pregnancy test done =< 7 days prior to randomization, for women of childbearing potential only
- •Willing to provide mandatory baseline blood samples for correlative research purposes
排除标准
- •Symptomatic and/or untreated brain metastases
- •Ongoing parenteral nutrition (receiving intravenous nutrition support at the time of enrollment); note: patients may be receiving maintenance intravenous (IV) fluids
- •Current enrollment in any other trial that entails the concurrent administration of any other agent designed to enhance postoperative recovery
- •Allergy to beef
研究组 & 干预措施
Arm I (serum-derived bovine immunoglobulin protein isolate)
Patients receive SBI PO BID on days 1-28.
Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.
干预措施: serum-derived bovine immunoglobulin protein isolate (Biological)
Arm I (serum-derived bovine immunoglobulin protein isolate)
Patients receive SBI PO BID on days 1-28.
Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.
干预措施: laboratory biomarker analysis (Other)
Arm I (serum-derived bovine immunoglobulin protein isolate)
Patients receive SBI PO BID on days 1-28.
Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.
干预措施: quality-of-life assessment (Other)
Arm I (serum-derived bovine immunoglobulin protein isolate)
Patients receive SBI PO BID on days 1-28.
Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.
干预措施: questionnaire administration (Other)
Arm II (placebo)
Patients receive placebo PO BID on days 1-28.
Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.
干预措施: placebo (Other)
Arm II (placebo)
Patients receive placebo PO BID on days 1-28.
Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.
干预措施: laboratory biomarker analysis (Other)
Arm II (placebo)
Patients receive placebo PO BID on days 1-28.
Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.
干预措施: quality-of-life assessment (Other)
Arm II (placebo)
Patients receive placebo PO BID on days 1-28.
Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.
干预措施: questionnaire administration (Other)
结局指标
主要结局
Time-to-QOL Improvement Defined as Any Increase in the QOL Score Measured Using the Total Score of the 14-item Postoperative Quality of Life (PQL) Tool
时间窗: up to 25 months
For this endpoint, the total QOL score could range from 1 to 140 (0 being the worst and 140 being the best). The primary analysis will be a comparison of oral SBI vs. placebo using a two-sided log-rank test between the 2 Kaplan-Meier curves.the total score of the 14-item Postoperative Quality of Life (PQL) tool \[15\] will be used, where the total score could range from 0 to 140 (0 being the worst and 140 being the best). These scores will be converted to the percentage scale, where a score of 140 will be converted to 100 and a score of 0 will remain as 0. This QOL will be measured weekly for the entire 12 week length of the study and at the end of the intervention. QOL improvement will be defined as at least a 10 point increase in the QOL score from baseline, on the percentage scale.
次要结局
- Intervention Compliance Assessed Using the Compliance Questionnaire(up to 25 months)
- Overall Adverse Event Rates for Grade 2 or Higher Adverse Events, Graded According to the Common Terminology Criteria for Adverse Events Version 4.0(up to 25 months)
- Change in QOL in Patients Who do Not Start Intervention or Discontinue Early, Measured Using the 14-item PQL Tool, Uniscale, and the Previously-validated Symptom Distress Scale(Baseline up to 25 months)
- Surgical Complication Rates(Up to 1 month post-surgery)
- Change in QOL Measured Using the 14-item PQL Tool, Uniscale, and the Previously-validated Symptom Distress Scale(up to 25 months)