Oral Supplementation to Enhance Recovery Pilot Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Determination if novel immunonutrition regimen is able to be implemented with adequate compliance in Radical Cystectomy (RC) patients: Participant Compliance
研究概览
简要总结
The goal of this clinical research study is to learn the supplements Pro-Stat (which has l-arginine and also contains protein) and omega-3 fatty acids will be well tolerated in patients who have radical cystectomy for bladder cancer. Researchers also want to learn how these medications affect inflammation and recovery for these surgical patients.
This is an investigational study. Pro-Stat is not FDA-approved to treat any specific condition or disease. Omega-3 fatty acids are FDA-approved to treat high triglyceride levels. Their use to treat inflammation and help improve recovery after bladder cancer surgery is investigational.
The study doctor can explain how the supplements are designed to work.
Up to 46 participants will be enrolled in this study. All will take part at MD Anderson.
详细描述
If you agree to take part in this study, you will be asked to perform a few tasks to learn about your strength, memory, and nutrition. These should take about 20 minutes to complete.
Study Groups:
You will be randomly assigned (as in the flip of a coin) into 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group.
- If you are in Group 1, you will receive the Pro-Stat and omega-3 fatty acid supplements.
- If you are in Group 2, you will not receive the Pro-Stat and omega-3 fatty acid supplements.
You will be asked to write down any supplements you take in a diary that will be provided to you. You should write down any supplements you take for the week before and 2 weeks after surgery. Please bring this diary to your follow up appointment after surgery.
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
- None
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
- •All patients undergoing RC for bladder cancer with urinary diversion at MD Anderson Cancer Center (MDACC). All races and ethnicities will be included
- •Patients must be willing to spend time for the study
- •Patient must provide signed informed consent.
- •Male or female, age >/= 18 years.
- •Adequate hepatic function: alkaline phosphatase </= 1.5 x Upper Limit of Normal (ULN); total bilirubin, aspartate aminotransferase (AST), and Alanine aminotransferase (ALT) </= 1.5 x ULN; international normalized ratio (INR) <1.3 (or <3 if on anticoagulant therapy).
排除标准
- •Subjects will be excluded if they do not attend pre-operative clinic dedicated to RC subjects.
- •Subjects with allergies to any supplements.
- •Subjects with galactosemia will be excluded.
- •Subjects may be excluded if they have known autoimmune inflammatory disease. (e.g. rheumatoid arthritis, ulcerative colitis, gout, chronic steroids).
- •Hepatic impairment: alkaline phosphate > 1.5 x ULN; total bilirubin, AST, and ALT > 1.5 x ULN; INR >1.3 (or >3 if on anticoagulant therapy).
- •Previously unable to tolerate either supplement due to taste or gastrointestinal (GI) side effects.
- •Any active malignancies being treated other than bladder cancer (incidentally found prostate cancer at RC is acceptable).
- •Unwillingness or inability to comply with mandated blood draws.
- •Any previous immunotherapy with immune checkpoint inhibitors such was Nivolumab, Atezolizumab and others in the class
研究组 & 干预措施
Immunonutrition: ARS + Omega-3 Fatty Acids
Participants take 1 ounce (30mls) of Arginine recovery supplement (ARS) four times daily 5 days preoperatively and 14 days postoperatively.
Participants also given omega-3 fatty acids, 1 gram four times a day, 4 grams total per day. This will be started 7 days preoperatively and continued 14 days postoperatively.
干预措施: Arginine recovery supplement (Drug)
Immunonutrition: ARS + Omega-3 Fatty Acids
Participants take 1 ounce (30mls) of Arginine recovery supplement (ARS) four times daily 5 days preoperatively and 14 days postoperatively.
Participants also given omega-3 fatty acids, 1 gram four times a day, 4 grams total per day. This will be started 7 days preoperatively and continued 14 days postoperatively.
干预措施: Omega-3 Fatty Acids (Dietary Supplement)
结局指标
主要结局
Determination if novel immunonutrition regimen is able to be implemented with adequate compliance in Radical Cystectomy (RC) patients: Participant Compliance
时间窗: 21 days after starting immunonutrition regimen
Participant compliance defined as "Yes" if a participant completes at least 16 out of the total 21 days' treatment.
次要结局
- Decrease in Inflammatory Response of Serum Interleukin-6 Levels After Radical Cystectomy (RC) postoperative day 1(1 day after surgery)
- Determination if Poor Recovery is Associated With the Use Immunonutrition Before and After Radical Cystectomy (RC): Length of Hospital Stay>7 Days(90 days after surgery)
- Determination if Poor Recovery is Associated With the Use Immunonutrition Before and After Radical Cystectomy (RC): Postoperative Infections(90 days after surgery)
- Determination if Poor Recovery is Associated With the Use Immunonutrition Before and After Radical Cystectomy (RC): Hospital Readmissions(90 days after surgery)
- Determination if Poor Recovery is Associated With the Use Immunonutrition Before and After Radical Cystectomy (RC): Deaths within 90 days of Cystectomy(90 days after surgery)