Pancreatic CancerNCT06570174
Oral Protein Supplements for Nutritional and Quality of Life Improvement After Pancreatic Resection in Elderly Patients
A study testing oral protein supplements in people with Pancreatic Cancer and Cholangiocarcinoma, run by Yonsei University at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Pancreatic Cancer, Cholangiocarcinoma, Intraductal Papillary Mucinous Neoplasm
- What is being tested?
- oral protein supplements
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Jan 2021to 18 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Surgery, Yonsei University College of Medicine
Seoul, 03722
About this study
Official title: 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.
Read the 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.
- Conditions
- Pancreatic Cancer, Cholangiocarcinoma, Intraductal Papillary Mucinous Neoplasm, Neuroendocrine Tumor, Solid Pseudopapillary Tumor
- Being tested
- oral protein supplements, placebo
- Medical subject headings
- Pancreatic Neoplasms, Cholangiocarcinoma, Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral protein supplementsDietary 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.
placeboGenetic
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Genetic: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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].
Measured: 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).
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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)."
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start7 Jan 2021
- Primary completion18 Jul 2022
- Study completion18 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06570174
- Sponsor's protocol ID
- 4-2020-0552
- Status last verified
- Aug 2024
- First submitted
- 18 Aug 2024
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Protein Supplements Might Improve Nutritional Status and Quality of Life in Elderly Patients After Standard Pancreatic Resection
- ClinicalTrials.gov ID
- NCT06570174
- Acronym / sponsor ID
- 4-2020-0552
- Conditions
- Pancreatic Cancer, Cholangiocarcinoma, Intraductal Papillary Mucinous Neoplasm, Neuroendocrine Tumor, Solid Pseudopapillary Tumor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 7 Jan 2021 (actual)
- Primary completion
- 18 Jul 2022 (actual)
- Study completion
- 18 Jul 2022 (actual)
- First posted
- 26 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protein Supplement group | Experimental | Dietary Supplement: oral protein supplementsThis 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. |
| Placebo group | Placebo comparator | Genetic: placeboThis 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Patients aged 65 years or older who were diagnosed with and underwent surgery for one of the following cancers:
Key exclusion criteria (8 listed)
- Patients were excluded from the study if they met any of the following criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral protein supplementsParticipants 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. | Dietary supplement | Protein Supplement group |
| placeboParticipants 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. | Genetic | Placebo group |
Primary outcome
Muscle mass
Time frame: 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)."
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].
nutritional status
Time frame: 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 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).
3 secondary outcomes
Intake
Time frame: 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
Time frame: 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)
Time frame: 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)."
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Pancreatic Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral protein supplements in people with Pancreatic Cancer and Cholangiocarcinoma, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle mass (time frame: 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)."). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024.