Clinical trial NCT06645912: Effect of High Protein ONS on Older Gastric Cancer Patients Receiving Neoadjuvant Chemotherapy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Locally Advanced Gastric Adenocarcinoma
Keywords: Gastric cancer
Older patients
Oral nutritional supplement
Lead sponsor: Erzincan Binali Yildirim University Mengucek Gazi Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2024-10-17
Enrollment: 46
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized ıntervantıonal study
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Change in Mini Nutritional Assessment (MNA) score
timeFrame: Baseline and 8 Weeks
measure: Change in Handgrip Strength
timeFrame: Baseline and 8 Weeks
measure: Change in EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30) score
timeFrame: Baseline and 8 Weeks
measure: Change in 'Activities of Daily Living' (ADL) Score
timeFrame: Baseline and 8 Weeks
measure: Change in 'Instrumental Activities of Daily Living' (IADL) Score
timeFrame: Baseline and 8 Weeks
Secondary outcomes:
measure: Change in Body Weight
timeFrame: Baseline and 8 Weeks
measure: Change in Body Mass Index (BMI)
timeFrame: Baseline and 8 Weeks
measure: Change in Mid-Upper Arm Circumference
timeFrame: Baseline and 8 Weeks
measure: Change in Calf Circumference
timeFrame: Baseline and 8 Weeks
measure: Changes in Bioelectrical Impedance Analysis (BIA)
timeFrame: Baseline and 8 Weeks
Other outcomes:
Locations:
city: Erzincan
country: Turkey
facility: Erzincan Binali Yıldırım Üniversitesi Mengücek Gazi Eğitim ve Araştırma. Hastanesi
state: Merkez
Study officials:
affiliation: Erzincan Mengucek Gazi Research and Training Hospital
name: Diğdem DOĞAN AKAGÜNDÜZ
role: STUDY_DIRECTOR
References: