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

NCT ID: NCT06645912

Last Updated: 2024-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2024-02-23

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 (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.

Conditions

Locally Advanced Gastric Adenocarcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

ONS and standard nutrition support

Patients receiving high protein containing oral nutritional supplement with standart nutritional support

Group Type: EXPERIMENTAL

oral nutritional supplement

Intervention Type: DIETARY_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.

standart nutrition support

Patients receiving only standart nutritional support

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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)

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erzincan Binali Yildirim University Mengucek Gazi Training and Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Baran Akagündüz

MD, Associate Proffesor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Diğdem DOĞAN AKAGÜNDÜZ

Role: STUDY_DIRECTOR

Erzincan Mengucek Gazi Research and Training Hospital

Locations

Erzincan Binali Yıldırım Üniversitesi Mengücek Gazi Eğitim ve Araştırma. Hastanesi

Erzincan, Merkez, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Dogan Akagunduz D, Turker PF, Akagunduz B. Effects of high-protein nutritional supplementation on nutritional status, physical function, and quality of life in older gastric cancer patients receiving neoadjuvant chemotherapy: a randomized trial. Support Care Cancer. 2025 Aug 9;33(9):775. doi: 10.1007/s00520-025-09822-x.

Reference Type: DERIVED

PMID: 40782206 (View on PubMed)

Other Identifiers

2022-7/14

Identifier Type: -

Identifier Source: org_study_id