Gastric Cancer (Diagnosis)NCT07201857
Peri-habilitation for Patients With Gastric Cancer
A study testing nutrition education plus active supplement and Exercise in people with Gastric Cancer (Diagnosis) and Gastric Cancer Patient, run by Korea University Anam Hospital at 1 site in South Korea.
Trial summary
This study aims to evaluate the clinical applicability of a peri-habilitation program in patients with gastric cancer by applying nutritional intervention for approximately two weeks before surgery and a combined exercise and nutrition intervention for about three weeks after hospital discharge, and by analyzing its… Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Gastric Cancer (Diagnosis), Gastric Cancer Patient, Gastric Cancer Patients Undergoing Gastrectomy
- What is being tested?
- nutrition education plus active supplement and Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Oct 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients aged 65 years or older who have been diagnosed with gastric cancer and are scheduled to undergo surgical treatment or chemotherapy.
Who cannot join
- Patients with severe conditions who are unable to undergo the intervention prior to surgical treatment or chemotherapy.
- Patients with physical (e.g., musculoskeletal) or mental disorders that make participation in or continuation of the program impossible.
- Patients judged to be at risk of additional physical burden from the intervention.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Anam Hospital
Seoul, seongbuk-gu, 02841
seokjun Cho, Ph.D student, 821040493206, zwx0209@korea.ac.kr
About this study
Official title: Peri-habilitation to Enhance Treatment Outcomes and Postoperative Recovery in Patients With Gastric Cancer
This study aims to evaluate the clinical applicability of a peri-habilitation program in patients with gastric cancer by applying nutritional intervention for approximately two weeks before surgery and a combined exercise and nutrition intervention for about three weeks after hospital discharge, and by analyzing its effects on the prevention of postoperative complications and recovery.
- Conditions
- Gastric Cancer (Diagnosis), Gastric Cancer Patient, Gastric Cancer Patients Undergoing Gastrectomy, Gastric Cancer Patients Undergoing Minimally Invasive Gastrectomy, Gastric Cancer Patients Undergoing Laparoscopic Gastrectomy
- Being tested
- nutrition education plus active supplement, Exercise
- Keywords
- peri-habilitation, gastric cancer, postoperative recovery, exercise intervention
- Medical subject headings
- Stomach Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutrition education plus active supplementDietary supplement
Also called Nutrition
Nutrition Group (NUT) Participants will receive standard clinical care combined with nutrition education and protein-enriched soy milk supplementation for approximately 2 weeks before surgery and about 3 weeks after hospital discharge.
ExerciseBehavioural
Also called Exercise and Nutrition
Exercise and Nutrition
Participants will receive peri-habilitation exercise training together with nutritional intervention, including carbohydrate plus protein-enriched soy milk supplementation twice daily (before and after exercise), for approximately 2 weeks before surgery and about 3 weeks after hospital discharge.
| Study group | Role | What they receive |
|---|---|---|
| Nutrition (NUT) | Active comparator | Nutrition (NUT) Participants will receive standard clinical care combined with nutrition education and protein-enriched soy milk supplementation for approximately 2 weeks before surgery and about 3 weeks after hospital discharge. Receives: Dietary Supplement: nutrition education plus active supplement |
| Exercise and Nutrition(EN) | Experimental | Exercise and Nutrition Group (EN)
Participants will receive peri-habilitation exercise training in combination with nutritional intervention, including carbohydrate plus protein-enriched soy milk supplementation twice daily (before and after exercise), for approximately 2 weeks before surgery and about 3 weeks after hospital discharge. Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait speed test
- Time to walk 4 meters (or 3 meters) at a normal, comfortable pace.
- Seconds(sec)
- Lower values(seconds) indicate better performance (faster walking speed)
Measured: Baseline (2 weeks before surgery) Preoperative hospitalization (1-4 days before surgery) Postoperative discharge (at hospital discharge) 3 weeks after discharge 6 months after surgery
Chair stand test
- Time to stand up and sit down 5 times from a chair without using the arms.
- Seconds(sec)
- Lower values(seconds) indicate better performance.
Measured: Baseline (2 weeks before surgery) Preoperative hospitalization (1-4 days before surgery) Postoperative discharge (at hospital discharge) 3 weeks after discharge 6 months after surgery
Balance test
- Time maintaining balance in three positions (feet together, semi-tandem, and tandem stance). The maximum time allowed for each position is 10 seconds.
- Seconds(sec)
- Higher values(seconds) indicate better performance.
Measured: Baseline (2 weeks before surgery) Preoperative hospitalization (1-4 days before surgery) Postoperative discharge (at hospital discharge) 3 weeks after discharge 6 months after surgery
Timed up and go test
- Time to stand up from a chair, walk 3 meters, turn around, walk back, and sit down.
- Seconds(sec)
- Lower values(seconds) indicate better performance.
Measured: Baseline (2 weeks before surgery) Preoperative hospitalization (1-4 days before surgery) Postoperative discharge (at hospital discharge) 3 weeks after discharge 6 months after surgery
Secondary outcomes (5)
Electrocardiogram(ECG)
- Cardiovascular status assessed using electrocardiogram (ECG)
- N/A (qualitative/clinical assessment)
- Abnormal ECG findings indicate impaired cardiovascular function.
Measured: Baseline (2 weeks before surgery) Preoperative hospitalization (1-4 days before surgery) Postoperative discharge (at hospital discharge) 3 weeks after discharge 6 months after surgery
Inflammation and Oxidative Stress Markers (Blood Analysis)
- Inflammatory and oxidative stress markers assessed by blood analysis, including C-reactive protein (CRP) and white blood cell(WBC) count.
- mg/L for CRP; ×10⁹/L for WBC
- Higher values indicate greater systemic inflammation.
Measured: Baseline (2 weeks before surgery) Preoperative hospitalization (1-4 days before surgery) Postoperative discharge (at hospital discharge) 3 weeks after discharge 6 months after surgery
Hospital Anxiety and Depression Scale (HADS)
- The scale ranges from 0 to 21 points for each domain (anxiety and depression). Higher scores indicate worse psychological distress.
- Score on a scale (0-21)
- Higher scores indicate worse psychological condition.
Measured: Baseline (2 weeks before surgery) Postoperative discharge (at hospital discharge) 3 weeks after discharge 6 months after surgery
Quality of life(KOQUSS-32, KOQUSS-40)
- Quality of life assessed using the Korean Quality of Life in Stomach Cancer Patient Study group questionnaires (KOQUSS-32 and KOQUSS-40). Each questionnaire provides domain-specific scores. Higher scores indicate better quality of life.
- Score on a scale (range depends on quetionnaire)
- Higher scores indicate better quality of life.
Measured: Baseline (2 weeks before surgery) 3 weeks after discharge 6 months after surgery
Clavien-dindo classification
- Postoperative complications will be assessed and graded according to the Clavien-Dindo classification system (Grade I-V).
- Number of participants with each complication grade.
- Higher grades indicate more severe postoperative complications.
Measured: Postoperative discharge (at hospital discharge) 3 weeks after discharge 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start15 Oct 2025 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer (Diagnosis)Studies 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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Korea University
- Responsible party
- Principal investigator, Min, Jae-Seok, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07201857
- Sponsor's protocol ID
- KUMCANAM2025GES1
- Status last verified
- Sep 2025
- First submitted
- 16 Sep 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-habilitation to Enhance Treatment Outcomes and Postoperative Recovery in Patients With Gastric Cancer
- ClinicalTrials.gov ID
- NCT07201857
- Acronym / sponsor ID
- KUMCANAM2025GES1
- Conditions
- Gastric Cancer (Diagnosis), Gastric Cancer Patient, Gastric Cancer Patients Undergoing Gastrectomy, Gastric Cancer Patients Undergoing Minimally Invasive Gastrectomy, Gastric Cancer Patients Undergoing Laparoscopic Gastrectomy
- Keywords
- peri-habilitation, gastric cancer, postoperative recovery, exercise intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Collaborators
- Korea University
- Study start
- 15 Oct 2025 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Oct 2025 (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 study aims to evaluate the clinical applicability of a peri-habilitation program in patients with gastric cancer by applying nutritional intervention for approximately two weeks before surgery and a combined exercise and nutrition intervention for about three weeks after hospital discharge, and by analyzing its effects on the prevention of postoperative complications and recovery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutrition (NUT) | Active comparator | Dietary Supplement: nutrition education plus active supplementNutrition (NUT) Participants will receive standard clinical care combined with nutrition education and protein-enriched soy milk supplementation for approximately 2 weeks before surgery and about 3 weeks after hospital discharge. |
| Exercise and Nutrition(EN) | Experimental | Behavioral: ExerciseExercise and Nutrition Group (EN) Participants will receive peri-habilitation exercise training in combination with nutritional intervention, including carbohydrate plus protein-enriched soy milk supplementation twice daily (before and after exercise), for approximately 2 weeks before surgery and about 3 weeks after hospital discharge. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Patients aged 65 years or older who have been diagnosed with gastric cancer and are scheduled to undergo surgical treatment or chemotherapy.
Key exclusion criteria (3 listed)
- Patients with severe conditions who are unable to undergo the intervention prior to surgical treatment or chemotherapy.
- Patients with physical (e.g., musculoskeletal) or mental disorders that make participation in or continuation of the program impossible.
- Patients judged to be at risk of additional physical burden from the intervention.
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 |
|---|---|---|
| nutrition education plus active supplementAlso: NutritionNutrition Group (NUT) Participants will receive standard clinical care combined with nutrition education and protein-enriched soy milk supplementation for approximately 2 weeks before surgery and about 3 weeks after hospital discharge. | Dietary supplement | Nutrition (NUT) |
| ExerciseAlso: Exercise and NutritionExercise and Nutrition Participants will receive peri-habilitation exercise training together with nutritional intervention, including carbohydrate plus protein-enriched soy milk supplementation twice daily (before and after exercise), for approximately 2 weeks before surgery and about 3 weeks after hospital discharge. | Behavioural | Exercise and Nutrition(EN) |
Primary outcome
Gait speed test
Time frame: Baseline (2 weeks before surgery) Preoperative hospitalization (1-4 days before surgery) Postoperative discharge (at hospital discharge) 3 weeks after discharge 6 months after surgery
* Time to walk 4 meters (or 3 meters) at a normal, comfortable pace. * Seconds(sec) * Lower values(seconds) indicate better performance (faster walking speed)
Chair stand test
Time frame: Baseline (2 weeks before surgery) Preoperative hospitalization (1-4 days before surgery) Postoperative discharge (at hospital discharge) 3 weeks after discharge 6 months after surgery
* Time to stand up and sit down 5 times from a chair without using the arms. * Seconds(sec) * Lower values(seconds) indicate better performance.
Balance test
Time frame: Baseline (2 weeks before surgery) Preoperative hospitalization (1-4 days before surgery) Postoperative discharge (at hospital discharge) 3 weeks after discharge 6 months after surgery
* Time maintaining balance in three positions (feet together, semi-tandem, and tandem stance). The maximum time allowed for each position is 10 seconds. * Seconds(sec) * Higher values(seconds) indicate better performance.
Timed up and go test
Time frame: Baseline (2 weeks before surgery) Preoperative hospitalization (1-4 days before surgery) Postoperative discharge (at hospital discharge) 3 weeks after discharge 6 months after surgery
* Time to stand up from a chair, walk 3 meters, turn around, walk back, and sit down. * Seconds(sec) * Lower values(seconds) indicate better performance.
5 secondary outcomes
Electrocardiogram(ECG)
Time frame: Baseline (2 weeks before surgery) Preoperative hospitalization (1-4 days before surgery) Postoperative discharge (at hospital discharge) 3 weeks after discharge 6 months after surgery
Inflammation and Oxidative Stress Markers (Blood Analysis)
Time frame: Baseline (2 weeks before surgery) Preoperative hospitalization (1-4 days before surgery) Postoperative discharge (at hospital discharge) 3 weeks after discharge 6 months after surgery
Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline (2 weeks before surgery) Postoperative discharge (at hospital discharge) 3 weeks after discharge 6 months after surgery
Quality of life(KOQUSS-32, KOQUSS-40)
Time frame: Baseline (2 weeks before surgery) 3 weeks after discharge 6 months after surgery
Clavien-dindo classification
Time frame: Postoperative discharge (at hospital discharge) 3 weeks after discharge 6 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nutrition education plus active supplement and Exercise in people with Gastric Cancer (Diagnosis) and Gastric Cancer Patient, run by Korea University Anam Hospital at 1 site in South Korea.
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 1 inclusion and 3 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: opening soon, as of the sponsor's last update on 1 Oct 2025. 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 South Korea. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait speed test (time frame: Baseline (2 weeks before surgery) Preoperative hospitalization (1-4 days before surgery) Postoperative discharge (at hospital discharge) 3 weeks after discharge 6 months after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2025.