Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06645912
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-10-12
Brief Title:
Effect of High Protein ONS on Older Gastric Cancer Patients Receiving Neoadjuvant Chemotherapy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of High Protein Nutritional Supplementation on Nutritional Status Functional Capacity and Quality of Life in Older Patients With Gastric Cancer Receiving Neoadjuvant Chemotherapy
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This interventional prospective randomized controlled study was conducted to compare the effects of high-protein oral nutritional supplement ONS and medical nutritional therapy to medical nutrition therapy alone on nutritional status quality of life and physical function capacity after neoadjuvant chemotherapy in patients aged 65 and over with newly diagnosed locally advanced gastric cancer
Detailed Description:
This study is a prospective randomized controlled trial conducted from February 2023 to February 2024 focusing on the effects of high-protein oral nutritional supplementation ONS in older patients aged 65 and over with newly diagnosed locally advanced gastric cancer undergoing neoadjuvant chemotherapy NAC
Study Design
The trial involved two groups
Intervention group ONS group - Received ONS in addition to standard medical nutrition therapy
Control group non-ONS group - Received only standard medical nutrition therapy without ONS supplementation
Participants were randomized using computer-aided randomization with 28 patients in each group After excluding patients based on specific criteria eg discontinuation of chemotherapy refusal to consume ONS or non-compliance with nutrition therapy 23 patients remained in each group totaling 46 patients for final analysis
Patients in the ONS group received a high-protein supplement containing 188 g of protein 7 g of fat 28 g of carbohydrates and 250 calories per 200 mL Both groups received personalized medical nutrition therapy based on their nutritional needs calculated as 30 kcalkgday of energy and 15 gkgday of protein
Data Collection and Monitoring
Data was collected at three key time points
Baseline Week 0 Assessments included anthropometric measurements handgrip strength food intake records nutritional status evaluation Mini Nutritional Assessment biochemical markers quality of life EORTC QLQ-C30 functional status ADL and IADL and comorbidity index Charlson Comorbidity Index
Mid-Intervention Week 4 Food intake MNA and ONS adherence were re-assessed with the ONS follow-up form and new anthropometric data collected
Post-Intervention Week 8 Final assessments covered all previously mentioned parameters anthropometry handgrip strength MNA biochemical data ADL IADL EORTC QLQ-C30 alongside an evaluation of compliance and ONS consumption
Statistical Analysis
The primary outcome measures were changes in nutritional status physical function handgrip strength ADL IADL and quality of life EORTC QLQ-C30 between baseline and week 8 Secondary outcomes included body composition changes measured by BIA adverse events CTCAE v50 and dietary intake analysis using BEBIS software The interventions impact was evaluated by comparing pre- and post-intervention changes between the two groups
Study Design
The trial involved two groups
Intervention group ONS group - Received ONS in addition to standard medical nutrition therapy
Control group non-ONS group - Received only standard medical nutrition therapy without ONS supplementation
Participants were randomized using computer-aided randomization with 28 patients in each group After excluding patients based on specific criteria eg discontinuation of chemotherapy refusal to consume ONS or non-compliance with nutrition therapy 23 patients remained in each group totaling 46 patients for final analysis
Patients in the ONS group received a high-protein supplement containing 188 g of protein 7 g of fat 28 g of carbohydrates and 250 calories per 200 mL Both groups received personalized medical nutrition therapy based on their nutritional needs calculated as 30 kcalkgday of energy and 15 gkgday of protein
Data Collection and Monitoring
Data was collected at three key time points
Baseline Week 0 Assessments included anthropometric measurements handgrip strength food intake records nutritional status evaluation Mini Nutritional Assessment biochemical markers quality of life EORTC QLQ-C30 functional status ADL and IADL and comorbidity index Charlson Comorbidity Index
Mid-Intervention Week 4 Food intake MNA and ONS adherence were re-assessed with the ONS follow-up form and new anthropometric data collected
Post-Intervention Week 8 Final assessments covered all previously mentioned parameters anthropometry handgrip strength MNA biochemical data ADL IADL EORTC QLQ-C30 alongside an evaluation of compliance and ONS consumption
Statistical Analysis
The primary outcome measures were changes in nutritional status physical function handgrip strength ADL IADL and quality of life EORTC QLQ-C30 between baseline and week 8 Secondary outcomes included body composition changes measured by BIA adverse events CTCAE v50 and dietary intake analysis using BEBIS software The interventions impact was evaluated by comparing pre- and post-intervention changes between the two groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None