Oral Protein Supplements for Nutritional and Quality of Life Improvement After Pancreatic Resection in Elderly Patients

Oral Protein Supplements Might Improve Nutritional Status and Quality of Life in Elderly Patients After Standard Pancreatic Resection

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.

Study Overview

• Status: Completed
• Conditions: Pancreatic Cancer; Neuroendocrine Tumor; Cholangiocarcinoma; Intraductal Papillary Mucinous Neoplasm; Solid Pseudopapillary Tumor
• Intervention / Treatment: Dietary supplement: oral protein supplements; Genetic: placebo

Detailed Description

This study was a randomized, double-blind, placebo-controlled clinical trial conducted to assess the effects of oral protein supplements on nutritional status and quality of life in elderly patients following pancreaticobiliary surgery. The study included elderly patients aged 65 years or older who underwent surgery for pancreaticobiliary cancer. The trial was conducted between January 7, 2021, and July 18, 2022.

A total of 60 patients were initially enrolled, but after 19 dropouts, the final analysis was based on 41 patients (18 in the placebo group and 23 in the experimental group). The experimental group received protein supplements providing 18g of protein per day, while the control group received a placebo containing carbohydrates instead of protein.

Key outcomes such as nutrient intake, nutritional status, quality of life, muscle mass, muscle strength, and 10-meter gait speed were measured at three time points: before surgery, at discharge, and during an outpatient visit. The data were analyzed using a Linear Mixed-Effects Model to evaluate the effects of the intervention.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Department of Surgery, Yonsei University College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients aged 65 years or older who were diagnosed with and underwent surgery for one of the following cancers:

  1. pancreatic cancer
  2. cholangiocarcinoma
  3. intraductal papillary mucinous neoplasm
  4. neuroendocrine tumor
  5. solid pseudopapillary tumor.

Exclusion Criteria:

• Patients were excluded from the study if they met any of the following criteria:

  1. Patients who were assessed as severely malnourished before surgery (PG-SGA grade C);
  2. Patients with an estimated glomerular filtration rate (eGFR) of less than 60 mL/min, or those diagnosed with chronic kidney disease and a history of related treatment;
  3. Patients with a body mass index (BMI) of 30 kg/m² or higher;
  4. Patients with ascites or edema severe enough to affect weight evaluation;
  5. Patients whose bioelectrical impedance analysis (BIA) could not be measured due to the use of pacemakers or implants;
  6. Patients whom the researcher deemed unable to participate in the study for psychological or cognitive reasons;
  7. Patients who did not provide consent for participation in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Protein Supplement group; This group received a daily oral protein supplement providing 18g of protein. The supplement was administered postoperatively and continued throughout the study period to evaluate its impact on nutritional status, quality of life, muscle mass, muscle strength, and gait speed.	Dietary supplement: oral protein supplements; Participants in this group received an oral protein supplement providing 18g of protein per day. The supplement was administered postoperatively and continued throughout the study period. The goal was to assess the impact of protein supplementation on protein intake, nutritional status, quality of life, muscle mass, muscle strength, and 10-meter gait speed. These outcomes were measured at three specific time points: before surgery, at discharge, and during the outpatient visit.
Placebo Comparator: Placebo group; This group received a placebo that contained carbohydrates instead of protein. The placebo was identical in appearance and taste to the protein supplement, ensuring the double-blind nature of the study. This arm was used to compare the effects of the protein supplement on the same outcomes.	Genetic: placebo; Participants in this group received a placebo supplement containing carbohydrates instead of protein, which was identical in appearance and taste to the protein supplement to maintain the study's double-blind design. The placebo was administered postoperatively and continued throughout the study period. The aim was to serve as a control to evaluate the effects of the protein supplement on outcomes including nutrient intake, nutritional status, quality of life, muscle mass, muscle strength, and 10-meter gait speed, measured at three key time points: before surgery, at discharge, and during the outpatient visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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)."

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2021
• Primary Completion (Actual): July 18, 2022
• Study Completion (Actual): July 18, 2022

Study Registration Dates

• First Submitted: August 18, 2024
• First Submitted That Met QC Criteria: August 22, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): August 26, 2024
• Last Update Submitted That Met QC Criteria: August 22, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Cholangiocarcinoma; Neuroendocrine Tumors; Neoplasms, Cystic, Mucinous, and Serous
• Other Study ID Numbers: 4-2020-0552

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No