A Longitudinal, Single Institution Study Evaluating Weight Stability in Advanced Pancreatic Cancer Patients With Cachexia Who Are Receiving Enteral Feeding
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Weight
研究概览
简要总结
Eligible patients will have a diagnosis of both pancreatic adenocarcinoma and cachexia defined as greater than 5% unintentional weight loss within 6 months prior to screening visit. Patients must be greater than 18 years of age; and have greater than 3 months life expectancy.
This study will observe a standard of care intervention (tube feeding) for potential benefit. Peptamen will be administered through a jejunal or a gastrojejunal feeding tube and dosing will be calculated using the Mifflin St. Jeor equation. It will be administered daily for the duration of the protocol.
详细描述
In this study, we will prospectively evaluate advanced pancreatic adenocarcinoma patients with cachexia, who are receiving enteral feeding, with a peptide based diet (medical food), through a jejunal or gastrojejunal feeding tube. We plan to collect serum samples routinely and establish a cohort of patients with this clinical syndrome. Our aims are to establish the feasibility and efficacy of enteral nutrition and its relationship to meaningful clinical outcomes. Furthermore, we will assess for a correlation between cachexia, activity, and patient reported outcomes on domains of quality of life in an optional activity tracker sub-study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Advanced or locally advanced pancreatic cancer patients (can include new or recurrent diagnosis) referred to SOCCI-CSMC for chemotherapy
- •Cachexia defined as greater than 5% unexplained weight loss within 6 months prior to screening visit or consultation with medical oncologist
- •Candidate for enteral feeding with Peptamen, a peptide based formula. Must have jejunal or gastrojejunal tube either previously placed or at least prior to Day 1 of study
- •Age ≥ 18 years.
- •ECOG performance status 0-2
- •Greater than or equal to 3 month life expectancy
- •Ability to understand and the willingness to sign a written informed consent
- •May have received prior anti-cancer treatment, complete or partial resection of primary tumor
- •Patients must be ambulatory and have access to a smart phone to participate in the activity tracker sub-study
排除标准
- •Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
- •Malignant ascites requiring paracenteses
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Bowel obstruction, partial or total
- •Pregnancy
结局指标
主要结局
Weight
时间窗: Change from baseline at 3 months
次要结局
- Change in lean body mass(Change from baseline at 3 months)
- Performance Status (ECOG)(Change from baseline at 3 months)
- Quality of Life (EORTC QLQ-C30)(Change from baseline at 3 months)
- Response to nutritional management(Change from baseline at 3 months)
- Food intake assessment by 24-hour recall(Change from baseline at 3 months)
- Smell and taste alteration by questionnaire(Change from baseline at 3 months)
- Muscle strength using hand grip strength dynamometer(Change from baseline at 3 months)
- Survival(3 years)
- Activity - steps taken(Change from baseline at 3 months)
- Activity - number of stairs(Change from baseline at 3 months)
- Activity - sleep duration and interruptions(Change from baseline at 3 months)
- Activity - heart rate(Change from baseline at 3 months)
- Changes in microbiome analysis(Change from baseline at 3 months)
研究者
Andrew Hendifar, MD
Assistant Professor of Medicine
Cedars-Sinai Medical Center