Locally Advanced Gastric AdenocarcinomaNCT06645912
Effect of High Protein ONS on Older Gastric Cancer Patients Receiving Neoadjuvant Chemotherapy
A study testing oral nutritional supplement in people with Locally Advanced Gastric Adenocarcinoma, run by Erzincan Binali Yildirim University Mengucek Gazi Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Locally Advanced Gastric Adenocarcinoma
- What is being tested?
- oral nutritional supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2023to 23 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- • 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erzincan Binali Yıldırım Üniversitesi Mengücek Gazi Eğitim ve Araştırma. Hastanesi
Erzincan, Merkez, 24000
About this study
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
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.
Read the 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
- Being tested
- oral nutritional supplement
- Keywords
- Gastric cancer, Older patients, Oral nutritional supplement
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral nutritional supplementDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| ONS and standard nutrition support | Experimental | Patients receiving high protein containing oral nutritional supplement with standart nutritional support Receives: Dietary Supplement: oral nutritional supplement |
| standart nutrition support | No intervention | Patients receiving only standart nutritional support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 8 Weeks
Secondary outcomes (5)
Change in Body Weight
Unit of Measure: Kilograms (kg). Body weight will be recorded in kilograms and tracked over time.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start1 Feb 2023
- Primary completion1 Feb 2024
- Study completion23 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Locally Advanced Gastric AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized ıntervantıonal study
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erzincan Binali Yildirim University Mengucek Gazi Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Baran Akagündüz, Erzincan Binali Yildirim University Mengucek Gazi Training and Research Hospital
- Investigators
- Diğdem DOĞAN AKAGÜNDÜZ, Study director, Erzincan Mengucek Gazi Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06645912
- Sponsor's protocol ID
- 2022-7/14
- Status last verified
- Oct 2024
- First submitted
- 12 Oct 2024
- Last updated
- 18 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40782206
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06645912
- Acronym / sponsor ID
- 2022-7/14
- Conditions
- Locally Advanced Gastric Adenocarcinoma
- Keywords
- Gastric cancer, Older patients, Oral nutritional supplement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Erzincan Binali Yildirim University Mengucek Gazi Training and Research HospitalOther government
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 23 Feb 2024 (actual)
- First posted
- 17 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized ıntervantıonal study
| Arm | Type | Receives |
|---|---|---|
| ONS and standard nutrition support | Experimental | Dietary Supplement: oral nutritional supplementPatients receiving high protein containing oral nutritional supplement with standart nutritional support |
| standart nutrition support | No intervention | –Patients receiving only standart nutritional support |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- • Aged 65 years or older.
Key exclusion criteria (6 listed)
- Severe comorbidities affecting survival within 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral nutritional supplementThe 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. | Dietary supplement | ONS and standard nutrition support |
Primary outcome
Change in Mini Nutritional Assessment (MNA) score
Time frame: Baseline and 8 Weeks
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).
Change in Handgrip Strength
Time frame: Baseline and 8 Weeks
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.
Change in EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30) score
Time frame: Baseline and 8 Weeks
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.
Change in 'Activities of Daily Living' (ADL) Score
Time frame: Baseline and 8 Weeks
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.
Change in 'Instrumental Activities of Daily Living' (IADL) Score
Time frame: Baseline and 8 Weeks
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.
5 secondary outcomes
Change in Body Weight
Time frame: Baseline and 8 Weeks
Change in Body Mass Index (BMI)
Time frame: Baseline and 8 Weeks
Change in Mid-Upper Arm Circumference
Time frame: Baseline and 8 Weeks
Change in Calf Circumference
Time frame: Baseline and 8 Weeks
Changes in Bioelectrical Impedance Analysis (BIA)
Time frame: Baseline and 8 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Derived from this study: PubMed 40782206Dogan 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.
- Individual participant dataSharing planned: No
Related trials for Locally Advanced Gastric Adenocarcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2
Perioperative Chemotherapy With Low-Dose Radiotherapy and Tislelizumab for Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Gastric or Gastroesophageal Junction Adenocarcinoma
Active, not recruitingPhase 2
Perioperative Cadonilimab (AK104) in Locally Advanced MSI-H/dMMR Gastric or Gastroesophageal Junction and Colorectal Adenocarcinoma
MSI-H/dMMR Gastric Carcinoma and Colorectal Cancer
Active, not recruitingPhase 2
Ramucirumab and Trifluridine/Tipiracil or Paclitaxel for the Treatment of Patients With Previously Treated Advanced Gastric or Gastroesophageal Junction Cancer
Clinical Stage III Gastric Cancer AJCC v8, Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
RecruitingPhase 3
A Study of Zolbetuximab Together With Pembrolizumab and Chemotherapy in Adults With Gastric Cancer
Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer, Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diğdem DOĞAN AKAGÜNDÜZ study director
Erzincan Mengucek Gazi Research and Training Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral nutritional supplement in people with Locally Advanced Gastric Adenocarcinoma, run by Erzincan Binali Yildirim University Mengucek Gazi Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Mini Nutritional Assessment (MNA) score (time frame: Baseline and 8 Weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06645912, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024.