Clinical trial NCT06570174: Oral Protein Supplements for Nutritional and Quality of Life Improvement After Pancreatic Resection in Elderly Patients
Official title: Oral Protein Supplements Might Improve Nutritional Status and Quality of Life in Elderly Patients After Standard Pancreatic Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Cancer
Cholangiocarcinoma
Intraductal Papillary Mucinous Neoplasm
Neuroendocrine Tumor
Solid Pseudopapillary Tumor
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Muscle mass
timeFrame: 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)."
measure: nutritional status
timeFrame: 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 outcomes:
measure: Intake
timeFrame: 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)."
measure: QoL
timeFrame: 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)."
measure: Walking Speed(Indicators Related to Sarcopenia)
timeFrame: 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)."
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Surgery, Yonsei University College of Medicine
Study officials:
References: