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

Erzincan Binali Yildirim University Mengucek Gazi Training and Research Hospital

Status

Completed

Conditions

Locally Advanced Gastric Adenocarcinoma

Treatments

Dietary Supplement: oral nutritional supplement

Study type

Interventional

Funder types

Other

Identifiers

NCT06645912

2022-7/14

Details and patient eligibility

About

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.

Full 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.

Enrollment

46 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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)