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

NCT06645912 | Completed

• 1 other identifier: 2022-7/14
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Locally Advanced Gastric Adenocarcinoma

Keywords

Gastric cancer; Older patients; Oral nutritional supplement

Outcome Measures

Primary Outcomes (5)

• 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 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 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 Outcomes (5)

• Change in Body Weight

  Baseline and 8 Weeks

• Change in Body Mass Index (BMI)

  Baseline and 8 Weeks

• Change in Mid-Upper Arm Circumference

  Baseline and 8 Weeks

• Change in Calf Circumference

  Baseline and 8 Weeks

• Changes in Bioelectrical Impedance Analysis (BIA)

  Baseline and 8 Weeks

Study Arms (2)

ONS and standard nutrition support

EXPERIMENTAL

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

Dietary Supplement: oral nutritional supplement

standart nutrition support

NO INTERVENTION

Patients receiving only standart nutritional support

Interventions

oral nutritional supplement 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.

ONS and standard nutrition support

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Erzincan Binali Yildirim University Mengucek Gazi Training and Research Hospital: lead

Study Sites (1)

Erzincan Binali Yıldırım Üniversitesi Mengücek Gazi Eğitim ve Araştırma. Hastanesi

Erzincan, Merkez, 24000, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 40782206 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Diğdem DOĞAN AKAGÜNDÜZ

  Erzincan Mengucek Gazi Research and Training Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Associate Proffesor

Model Details: Randomized ıntervantıonal study

Study Record Dates

• First Submitted: October 12, 2024
• First Posted: October 17, 2024
• Study Start: February 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 23, 2024
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)