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

NCT06570174 | Completed DMC

• 1 other identifier: 4-2020-0552
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer; Cholangiocarcinoma; Intraductal Papillary Mucinous Neoplasm; Neuroendocrine Tumor; Solid Pseudopapillary Tumor

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Intake

  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

  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)

  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)."

Study Arms (2)

Protein Supplement group

EXPERIMENTAL

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

Placebo group

PLACEBO COMPARATOR

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

Interventions

oral protein supplements DIETARY_SUPPLEMENT

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.

Protein Supplement group

placebo GENETIC

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.

Placebo group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients aged 65 years or older who were diagnosed with and underwent surgery for one of the following cancers:
• pancreatic cancer
• cholangiocarcinoma
• intraductal papillary mucinous neoplasm
• neuroendocrine tumor
• solid pseudopapillary tumor.

You may not qualify if:

• Patients were excluded from the study if they met any of the following criteria:
• Patients who were assessed as severely malnourished before surgery (PG-SGA grade C);
• 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;
• Patients with a body mass index (BMI) of 30 kg/m² or higher;
• Patients with ascites or edema severe enough to affect weight evaluation;
• Patients whose bioelectrical impedance analysis (BIA) could not be measured due to the use of pacemakers or implants;
• Patients whom the researcher deemed unable to participate in the study for psychological or cognitive reasons;
• Patients who did not provide consent for participation in this study.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Surgery, Yonsei University College of Medicine

Seoul, 03722, South Korea

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Cholangiocarcinoma; Neuroendocrine Tumors

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2024
• First Posted: August 26, 2024
• Study Start: January 7, 2021
• Primary Completion: July 18, 2022
• Study Completion: July 18, 2022
• Last Updated: August 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)