Effect of High Protein ONS on Older Gastric Cancer Patients Receiving Neoadjuvant Chemotherapy

Effect of High Protein Nutritional Supplementation on Nutritional Status, Functional Capacity and Quality of Life in Older Patients With Gastric Cancer Receiving Neoadjuvant Chemotherapy

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.

Study Overview

• Status: Completed
• Conditions: Locally Advanced Gastric Adenocarcinoma
• Intervention / Treatment: Dietary supplement: oral nutritional supplement

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 (e.g., 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 18.8 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 kcal/kg/day of energy and 1.5 g/kg/day 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 v5.0), and dietary intake analysis using BEBIS software. The intervention's impact was evaluated by comparing pre- and post-intervention changes between the two groups.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Merkez
    • Erzincan, Merkez, Turkey, 24000
      • Erzincan Binali Yıldırım Üniversitesi Mengücek Gazi Eğitim ve Araştırma. Hastanesi

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• • Aged 65 years or older.

  • Newly diagnosed histological confirmed locally advanced gastric cancer (Stage IIa to IIIa).
  • Scheduled to receive Neoadjuvant chemotherapy.
  • ECOG performance status of 0-2.
  • Signed informed consent to participate

Exclusion Criteria:

• Severe comorbidities affecting survival within 3 months.

  • Inability to comply with study procedures.
  • Previous gastric surgery or chemotherapy.
  • Metastatic dissease (Stage IV)
  • Poor performance status (ECOG 3-4)
  • Early satge (Stage I)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: standart nutrition support; Patients receiving only standart nutritional support
Experimental: ONS and standard nutrition support; Patients receiving high protein containing oral nutritional supplement with standart nutritional support	Dietary supplement: oral nutritional supplement; The ONS group received a high-protein ONS providing 18.8 g of protein, 7 g of fat, 28 g of carbohydrates, and 250 calories of energy per 200 mL and medical nutrition therapy. The product is gluten-free and contains lactose, minerals, trace elements, and vitamins . The Control group received only standard nutrition therapy without ONS supplementation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Handgrip Strength	Unit of Measure: Kilograms (kg). Measured with a hand dynamometer, the average handgrip strength (kg) will be calculated based on three measurements of the dominant hand.	Baseline and 8 Weeks
Change in Mini Nutritional Assessment (MNA) score	Unit of Measure: MNA score (Units on a Scale). This will measure changes in nutritional status using the MNA scoring system, which ranges from 0 to 30. A higher score indicates better nutritional status (24-30: normal nutritional status, 17-23.5: at risk of malnutrition, <17: malnourished).	Baseline and 8 Weeks
Change in EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30) score	Unit of Measure: QLQ-C30 score (Units on a Scale). The EORTC QLQ-C30 evaluates quality of life across multiple domains, including physical, emotional, and social functioning. Scores range from 0 to 100, with higher scores indicating better quality of life in functioning scales but worse symptoms when higher scores are in symptom scales.	Baseline and 8 Weeks
Change in 'Activities of Daily Living' (ADL) Score	Unit of Measure: ADL score (Units on a Scale). The ADL scale assesses the patient's ability to perform basic daily tasks, such as bathing, dressing, and feeding. Scores range from 0 to 6, with higher scores indicating better physical function and independence.	Baseline and 8 Weeks
Change in 'Instrumental Activities of Daily Living' (IADL) Score	Unit of Measure: IADL score (Units on a Scale). The IADL scale evaluates the patient's ability to perform more complex daily tasks, such as managing finances and using transportation. Scores range from 0 to 8, with higher scores reflecting better functional independence.	Baseline and 8 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Body Weight	Unit of Measure: Kilograms (kg). Body weight will be recorded in kilograms and tracked over time.	Baseline and 8 Weeks
Change in Body Mass Index (BMI)	Unit of Measure: kg/m². BMI will be calculated by dividing weight in kilograms by the square of height in meters.	Baseline and 8 Weeks
Change in Mid-Upper Arm Circumference	Unit of Measure: Centimeters (cm). This anthropometric measurement will be taken with a non-stretchable tape measure.	Baseline and 8 Weeks
Change in Calf Circumference	Unit of Measure: Centimeters (cm). Calf circumference will also be measured with a tape measure and recorded in centimeters.	Baseline and 8 Weeks
Changes in Bioelectrical Impedance Analysis (BIA)	Unit of Measure: Percentage (%). BIA will be used to assess body composition, such as body fat percentage and lean mass percentage.	Baseline and 8 Weeks

Collaborators and Investigators

• Sponsor: Erzincan Binali Yildirim University Mengucek Gazi Training and Research Hospital
• Investigators: Study Director: Diğdem DOĞAN AKAGÜNDÜZ, Erzincan Mengucek Gazi Research and Training Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): February 1, 2024
• Study Completion (Actual): February 23, 2024

Study Registration Dates

• First Submitted: October 12, 2024
• First Submitted That Met QC Criteria: October 15, 2024
• First Posted (Actual): October 17, 2024

Study Record Updates

• Last Update Posted (Actual): October 18, 2024
• Last Update Submitted That Met QC Criteria: October 16, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Gastric cancer; Older patients; Oral nutritional supplement
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: 2022-7/14

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