Nutrition Intervention for Pancreatic Cancer

Официальное название

Feasibility, Tolerance, and Fat Metabolism Pilot Study of a Structured Lipid Medical Food in Patients With Pancreatic Cancer

Обзор

Patients with pancreatic cancer (pancreatic ductal adenocarcinoma (PDAC) and pancreatic neuroendocrine tumor (NET)) commonly experience fat malabsorption due to exocrine pancreatic insufficiency (EPI) and leads to gastrointestinal (GI) symptoms, malnutrition, weight loss, and reduced quality of life (QoL). Current standard treatment, pancreatic enzyme replacement therapy (PERT), is limited by suboptimal adherence, high cost, and partial effectiveness to prevent fat malabsorption. The objective of the study is to assess the feasibility and maintenance of lipid absorption function of a structured lipid medical food (SLMF; Encala®) powder in subjects with PDAC and NET with EPI.

Подробное описание

This study is a prospective, single-arm pilot clinical trial designed to evaluate the feasibility, tolerance, safety, and potential effects of a structured lipid medical food (Encala®) in adult patients with pancreatic cancer, including pancreatic ductal adenocarcinoma (PDAC) and pancreatic neuroendocrine tumors (NET), who are at risk for exocrine pancreatic insufficiency (EPI) and fat malabsorption. Fat malabsorption is common in patients with pancreatic cancer due to impaired pancreatic enzyme function, leading to gastrointestinal symptoms, malnutrition, weight loss, and reduced quality of life. The structured lipid medical food evaluated in this study is designed to improve fat absorption without requiring pancreatic lipase or bile acids, potentially addressing a critical gap in nutritional support for this population.

This study will enroll approximately 18 adult participants recruited through the Penn Pancreatic Cancer Research Center. Participants will receive the study intervention over an 8-week period, during which they will consume 4-5 daily doses of the structured lipid medical food (approximately 400-500 kcal/day), mixed with preferred foods, beverages, or enteral feeding formulations.

Participants will undergo study assessments at baseline, 4 weeks, and 8 weeks. These assessments will include evaluation of gastrointestinal symptoms, nutritional status, dietary intake, body composition, and physical function. Laboratory measures, including plasma fatty acids and nutritional biomarkers, will be collected to assess changes in fat absorption and nutritional status. A malabsorption blood test (MBT) will also be used to evaluate intestinal fat absorption.

The primary outcomes of this study are feasibility, tolerance, and safety of the intervention. Secondary outcomes include changes in gastrointestinal symptoms, body weight, nutritional biomarkers, and measure of fat absorption (MBT) at baseline.

Findings from this pilot study will provide preliminary data on the feasibility and potential clinical benefits of this nutritional intervention and will inform the design of future larger-scale studies aimed at improving nutritional management and quality of life in patients with pancreatic cancer.

Вмешательства

• Другое Structured Lipid Medical Food
  Structured lipid medical food (Encala®) powder administered orally or via enteral feeding. Each dose consists of approximately 18.4 g (2 scoops) providing 100 kcal. Participants will receive 4-5 doses daily (total 400-500 kcal/day) for 8 weeks. The product is mixed with participant-selected foods, beverages, or tube feeding formula. Dosing is individualized based on weight status and recent weight loss.

Первичные конечные точки

• Feasibility of Encala Intervention ( Enrollment Rate ) [Срок оценки: From enrollment to end of intervention at 8 weeks]
• Change in PROMIS Gastrointestinal Symptom Score [Срок оценки: Baseline to Week 8]
• Feasibility of Encala Intervention ( Retention Rate ) [Срок оценки: Baseline to Week 8]
• Feasibility of Encala Intervention ( Visit Completion) [Срок оценки: Baseline to Visit 8]
• Feasibility of Encala Intervention ( Product Adherence ) [Срок оценки: Baseline to Visit 8]

Вторичные конечные точки (12)

• Baseline Malabsorption Blood Test (MBT) Area Under the Curve [Срок оценки: Baseline and Week 8]
• Change in Total Plasma Fatty Acid Concentration [Срок оценки: Baseline, 4 weeks, and 8 weeks]
• Change in Serum Prealbumin [Срок оценки: Baseline, 4 weeks, and 8 weeks]
• Change in Serum Vitamin A [Срок оценки: Baseline, 4 weeks, and 8 weeks]
• Change in Plasma Choline [Срок оценки: Baseline and 8 weeks]
• Change in Dietary Intake [Срок оценки: Baseline, 4 weeks, and 8 weeks]
• Change in Physical Function Short Physical Performance Battery (SPPB) [Срок оценки: Baseline, 4 weeks, and 8 weeks]
• Change in Quality of Life (PROMIS) Questionnaires [Срок оценки: Baseline, 4 weeks, and 8 weeks]
• Change in Hand Grip Strength [Срок оценки: Baseline, 4 weeks, and Week 8]
• Change in Body Weight [Срок оценки: Baseline, 4 weeks, and 8 weeks]
• Change in Fat Mass (kg) measured by DXA [Срок оценки: Baseline and 8 weeks]
• Change in Body Mass Index [Срок оценки: Baseline, Week 4, and Week 8]

Критерии участия

Критерии включения

• Pancreatic ductal adenocarcinoma or pancreatic neuroendocrine tumor diagnosis and age greater than or equal to 18 years
• Life expectancy of 4 months or greater
• Oral or enteral tube feeding for > 60% daily calories
• For patients with NET, evidence of GI dysfunction such as >5% unintentional weight loss, increased number of bowel movements¸change in stool consistency (e.g., soft stool or diarrhea), as documented in the medical record and confirmed by the treating oncologist.

Критерии исключения

• Pregnant or lactating
• Unable to consume food by mouth (oral intake)
• Allergy to soy lecithin product ingredients
• Psychosocial environment for which study participation may be difficult for subject or family, as confirmed by medical team
• Military service members, Reserve Service members, National Guard members, Department of Defense (DoD) civilians, and DoD contractors
• Patients with diminished capacity to consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 2 центра

• Children's Hospital of Philadelphia — Philadelphia
• University of Pennsylvania Abramson Cancer Center — Philadelphia

Публикации

• Mascarenhas MR, Mondick J, Barrett JS, Wilson M, Stallings VA, Schall JI. Malabsorption blood test: Assessing fat absorption in patients with cystic fibrosis and pancreatic insufficiency. J Clin Pharmacol. 2015 Aug;55(8):854-65. doi: 10.1002/jcph.484. Epub 2015 Mar 23. PMID 25689042
• Stallings VA, Schall JI, Maqbool A, Mascarenhas MR, Alshaikh BN, Dougherty KA, Hommel K, Ryan J, Elci OU, Shaw WA. Effect of Oral Lipid Matrix Supplement on Fat Absorption in Cystic Fibrosis: A Randomized Placebo-Controlled Trial. J Pediatr Gastroenterol Nutr. 2016 Dec;63(6):676-680. doi: 10.1097/MPG.0000000000001213. PMID 27050056
• Stallings VA, Tindall AM, Mascarenhas MR, Maqbool A, Schall JI. Improved residual fat malabsorption and growth in children with cystic fibrosis treated with a novel oral structured lipid supplement: A randomized controlled trial. PLoS One. 2020 May 8;15(5):e0232685. doi: 10.1371/journal.pone.0232685. eCollection 2020. PMID 32384122
• Tindall A, Mascarenhas M, Maqbool A, Stallings VA. Lysophosphatidylcholine-Rich Nutrition Therapy Increased Gut Absorption of Coingested Dietary Fat: a Randomized Controlled Trial. Curr Dev Nutr. 2023 Jul 31;7(9):101985. doi: 10.1016/j.cdnut.2023.101985. eCollection 2023 Sep. PMID 37671264

Идентификаторы

NCT: NCT07554560 · 25-023423 · HT94252510749

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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