Oral Protein Supplements for Nutritional and Quality of Life Improvement After Pancreatic Resection in Elderly Patients
NCT Number: NCT06570174
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pancreatic Cancer|Cholangiocarcinoma|Intraductal Papillary Mucinous Neoplasm|Neuroendocrine Tumor|Solid Pseudopapillary Tumor
Interventions: DIETARY_SUPPLEMENT: oral protein supplements|GENETIC: placebo
Sponsor: Yonsei University
Sex: ALL
Age: OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2021-01-07
Completion Date: 2022-07-18
Locations: Department of Surgery, Yonsei University College of Medicine, Seoul, 03722, Korea, Republic of

Summary:
This study investigates the effects of oral protein supplements on the nutritional status and quality of life in elderly patients following standard pancreatic resection. The research aims to determine whether these supplements can improve protein intake and contribute to better skeletal muscle mass, which is critical for recovery and overall health. The study hypothesizes that higher compliance with protein supplementation will be positively correlated with increased protein intake and improved muscle mass index, potentially leading to enhanced postoperative outcomes in this patient population.

Primary Outcome Measures: Muscle mass, Muscle mass was measured using the InBody S10 (InBody®, Seoul, Korea) device, which employs the Bioelectrical Impedance Analysis (BIA) method. Body Cell Mass (BCM), Phase Angle, and Skeletal Muscle Mass Index (SMI) were used for analysis. The SMI was calculated by dividing the appendicular skeletal muscle mass (ASM), which is the sum of the muscle mass of the limbs excluding the trunk, by the square of the height in meters \[SMI = ASM/height²\]., 1. The day before surgery (pre-OP), 2. Within 24 hours before the scheduled discharge date (DC; approximately 5 to 7 days postoperatively), 3. At the first outpatient visit following surgery (OPD; approximately 6 weeks postoperatively)."|nutritional status, Nutritional status was assessed using the Patient-Generated Subjective Global Assessment (PG-SGA). This tool involves patient-reported changes in weight, food intake, symptoms affecting intake, and activity level. A dietitian then evaluates factors like diagnosis, metabolic stress, body fat, muscle mass, and edema to classify the patient's nutritional status as well-nourished (Grade A), moderately malnourished (Grade B), or severely malnourished (Grade C)., 1. The day before surgery (pre-OP), 2. Within 24 hours before the scheduled discharge date (DC; approximately 5 to 7 days postoperatively), 3. At the first outpatient visit following surgery (OPD; approximately 6 weeks postoperatively)."
Secondary Outcome Measures: Intake, Usual intake before surgery was investigated using the 24-hour recall method. During the hospitalization period, the patients' daily intake was recorded using the self-developed "meal intake during hospitalization" survey. The patients were asked to write a "meal journal" and bring it with them at the time of their first outpatient visit. The patients' nutrient intake was analyzed using the "CAN-Pro 5.0(Web ver.) (Korean Nutrition Society, Seoul, Korea)" program., 1. The day before surgery (pre-OP), 2. Within 24 hours before the scheduled discharge date (DC; approximately 5 to 7 days postoperatively), 3. At the first outpatient visit following surgery (OPD; approximately 6 weeks postoperatively)."|QoL, The patients' quality of life was assessed using the "European Organization for Research and Treatment in Cancer 30 (EORTC QLQ-C30)" questionnaire, which is a questionnaire designed to evaluate the quality of life of cancer patients. The final score was calculated by adding the scores for the last two questions out of 30 evaluation questions on the subjects' overall quality of life. The higher the quality of life (QoL) score, the better the quality of life., 1. The day before surgery (pre-OP), 2. Within 24 hours before the scheduled discharge date (DC; approximately 5 to 7 days postoperatively), 3. At the first outpatient visit following surgery (OPD; approximately 6 weeks postoperatively)."|Walking Speed(Indicators Related to Sarcopenia), The time it took for the patients to walk 10 meters on a straight and flat surface was measured. Gait speed was measured in the hallway of the hospital ward during hospitalization and in the corridor of the clinic during outpatient visits. The patients were in structed to walk at their usual pace., 1. The day before surgery (pre-OP), 2. Within 24 hours before the scheduled discharge date (DC; approximately 5 to 7 days postoperatively), 3. At the first outpatient visit following surgery (OPD; approximately 6 weeks postoperatively)."