Stomach NeoplasmsNCT05352802
Multimodal Prehabilitation To Improve The Clinical Outcomes Of Frail Elderly Patients With Gastric Cancer
A study testing Multimodal prehabilitation program and ERAS protocol in people with Stomach Neoplasms and Frail Elderly, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial summary
The GISSG+2201 study was launched by Shandong Gastrointestinal Surgery Study Group (GISSG). The intention is to establish a multimodal prehabilitation protocol in frail elderly patients who undergo gastric cancer radical surgery, explore the feasibility and effectiveness of the measures and evaluate the effect of… Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Stomach Neoplasms, Frail Elderly
- What is being tested?
- Multimodal prehabilitation program and ERAS protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 368 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 1 May 2027
- 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 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Aged 65-85 years;
- Karnofsky performance score ≥70 or Eastern Cooperative Oncology Group (ECOG) performance status score ≤2;
- G8 score ≤14;
- Endoscopic biopsies were pathologically confirmed as gastric adenocarcinoma;
- Patients with cT1-4aN0-3M0 by endoscopy, imaging evaluations of CT and MRI, and possibility of gastric resection;
- Received general anesthesia or combined spinal-epidural anesthesia (Surgery was performed by either laparotomy, laparoscopy or robotic-assisted laparoscopic);
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- Date of surgery ≥2 weeks from baseline (T0) assessment;
- Physical conditions could meet the requirements of exercise training, and no severe concomitant disease;
- All subjects had to be willing and able to comply with study protocol and were informed adequately that they maintained the right to drop out of the study at any time.
Who cannot join
- Patients with uncontrolled seizure disorders, central nervous system diseases and mental disorders;
- End-stage cardiac insufficiency (LVEF<30% or NYHA class IV), liver cirrhosis (Child-Pugh classification C), End-stage renal failure (receives chronic dialysis), or ASA grade IV;
- Cerebral bleeding or infarction (within 6 months);
- Patients with recurrent infection diseases or serious concomitant disease;
- Patients who require synchronous surgery due to other illness;
- Patients who required emergency surgery within an emergency setting (obstruction, bleeding, perforation);
- Patients who are participating in any other clinical trials.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital
Qingdao, Shandong, 266000
About this study
Official title: Supervised Home-based Multimodal Prehabilitation to Improve the Clinical Outcomes of Frail Elderly Patients With Gastric Cancer: Multicenter Randomized Controlled Trial (GISSG+2201)
The GISSG+2201 study was launched by Shandong Gastrointestinal Surgery Study Group (GISSG). The intention is to establish a multimodal prehabilitation protocol in frail elderly patients who undergo gastric cancer radical surgery, explore the feasibility and effectiveness of the measures and evaluate the effect of program on short-term clinical outcome, recovery index and the long-term tumor-related outcome.
- Conditions
- Stomach Neoplasms, Frail Elderly
- Being tested
- Multimodal prehabilitation program, ERAS protocol
- Keywords
- Multimodal prehabilitation, ERAS
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal prehabilitation programBehavioural
Multimodal prehabilitation programs have adopted planned, structural, repetitive and purposeful approach that includes elements of exercise, nutritional and psychological.
ERAS protocolBehavioural
The core content is to adopt a series of optimized measures performed during the perioperative period on the basis of evidence-based medical findings to reduce the physiological and psychological stress of patients and to accelerate their recovery.
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation group | Experimental | The prehabilitation group received multimodal prehabilitation combined with ERAS before the gastrectomy. Receives: Behavioral: Multimodal prehabilitation program; Behavioral: ERAS protocol |
| ERAS group | Active comparator | The ERAS group patients were treated according to the ERAS pathway. Receives: Behavioral: ERAS protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and severity of postoperative complications
Major postoperative complications of patients with Gastrointestinal malignancy included gastrointestinal complication, surgical site complication, respiratory complication, cardiovascular complication, thromboembolic complication, urinary complication and other complications. The severity of complications was recorded and classified according to Clavien-Dindo classification score.
Measured: Postoperative (≤30 days after surgery)
Secondary outcomes (5)
Cardio-pulmonary function and physical capacity
The 6-minute walk test (6MWT) can be used to measure exercise capacity to reflect cardio-pulmonary function.
Measured: Baseline (T0), Post-intervention (up to 2 weeks), and POD 30（30 days after surgery）
Quality of life (QoL).
QoL comprises patient-reported outcomes (PRO) of physical symptoms and psychosocial health status. Quality of Life Questionnaire (QLQ) C30 is sensitive tool for measuring individual performance status. Each index score ranges from 1 to 4, with higher scores indicating higher risk.
Measured: Baseline (T0), Post-intervention (up to 2 weeks), and POD 30（30 days after surgery）
Detection of immune and inflammatory indicators
Interleukin, Tumor necrosis factor and C-reactive protein serum concentrations
Measured: Baseline (T0), Post-intervention (up to 2 weeks), and POD 30（30 days after surgery）
The postoperative other observation parameters
Postoperative pain severity, postoperative delirium severity and occurrence, first exhaust and defecation, ureteral catheter removal, abdominal drainage tubes removal, postoperative hospital stay, hospitalization costs, 30-day all-cause mortality and 30-day hospital readmission rate.
Measured: Postoperative (≤30 days after surgery)
Oncological outcomes
3-year recurrence-free survival (RFS) rate and 3-year overall survival (OS) rate.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start1 Sep 2022
- Primary completion13 Apr 2024
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stomach NeoplasmsStudies of the same condition, open and under way.
- More trials run by The Affiliated Hospital of Qingdao UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 368 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong Provincial Hospital, Qilu Hospital of Shandong University, Qianfoshan Hospital, Yantai Yuhuangding Hospital, Jining First People's Hospital, Weifang Medical University, Weifang People's Hospital, Dongying People's Hospital, Weihai Municipal Hospital, Weihai Central Hospital, Rizhao People's Hospital, Liaocheng People's Hospital
- Responsible party
- Sponsor
- Investigators
- Yanbing Zhou, MD, Study director, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05352802
- Sponsor's protocol ID
- GISSG+2201
- Status last verified
- Dec 2024
- First submitted
- 18 Apr 2022
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Sun Y, Tian Y, Cao S, Li L, Yu W, Ding Y, Wang X, Kong Y, Wang X, Wang H, Hui X, Qu J, Wang H, Duan Q, Yang D, Zhang H, Zhou S, Liu X, Li Z, Liu Q, Zhou Y. Supervised Multimodal Prehabilitation and Clinical Outcomes in Older Patients With Frailty and Gastric Cancer: The GISSG+2201 Randomized Clinical Trial. JAMA Surg. 2026 Mar 1;161(3):223-233. doi: 10.1001/jamasurg.2025.6256.
PubMed 41604182Sun Y, Tian Y, Cao S, Li L, Yu W, Ding Y, Wang X, Kong Y, Wang X, Wang H, Hui X, Qu J, Wang H, Duan Q, Yang D, Zhang H, Zhou S, Liu X, Li Z, Meng C, Kehlet H, Zhou Y. Multimodal prehabilitation to improve the clinical outcomes of frail elderly patients with gastric cancer: a study protocol for a multicentre randomised controlled trial (GISSG+2201). BMJ Open. 2023 Oct 10;13(10):e071714. doi: 10.1136/bmjopen-2023-071714.
PubMed 37816552
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supervised Home-based Multimodal Prehabilitation to Improve the Clinical Outcomes of Frail Elderly Patients With Gastric Cancer: Multicenter Randomized Controlled Trial (GISSG+2201)
- ClinicalTrials.gov ID
- NCT05352802
- Acronym / sponsor ID
- GISSG+2201
- Conditions
- Stomach Neoplasms, Frail Elderly
- Keywords
- Multimodal prehabilitation, ERAS
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 368 participants (actual)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Collaborators
- Shandong Provincial Hospital, Qilu Hospital of Shandong University, Qianfoshan Hospital, Yantai Yuhuangding Hospital, Jining First People's Hospital, Weifang Medical University, Weifang People's Hospital, Dongying People's Hospital, Weihai Municipal Hospital, Weihai Central Hospital, Rizhao People's Hospital, Liaocheng People's Hospital
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 13 Apr 2024 (actual)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 29 Apr 2022 (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.
The GISSG+2201 study was launched by Shandong Gastrointestinal Surgery Study Group (GISSG). The intention is to establish a multimodal prehabilitation protocol in frail elderly patients who undergo gastric cancer radical surgery, explore the feasibility and effectiveness of the measures and evaluate the effect of program on short-term clinical outcome, recovery index and the long-term tumor-related outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation group | Experimental | Behavioral: Multimodal prehabilitation program, Behavioral: ERAS protocolThe prehabilitation group received multimodal prehabilitation combined with ERAS before the gastrectomy. |
| ERAS group | Active comparator | Behavioral: ERAS protocolThe ERAS group patients were treated according to the ERAS pathway. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- Aged 65-85 years;
- Karnofsky performance score ≥70 or Eastern Cooperative Oncology Group (ECOG) performance status score ≤2;
- G8 score ≤14;
- Endoscopic biopsies were pathologically confirmed as gastric adenocarcinoma;
- Patients with cT1-4aN0-3M0 by endoscopy, imaging evaluations of CT and MRI, and possibility of gastric resection;
Key exclusion criteria (7 listed)
- Patients with uncontrolled seizure disorders, central nervous system diseases and mental disorders;
- End-stage cardiac insufficiency (LVEF<30% or NYHA class IV), liver cirrhosis (Child-Pugh classification C), End-stage renal failure (receives chronic dialysis), or ASA grade IV;
- Cerebral bleeding or infarction (within 6 months);
- Patients with recurrent infection diseases or serious concomitant disease;
- Patients who require synchronous surgery due to other illness;
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 |
|---|---|---|
| Multimodal prehabilitation programMultimodal prehabilitation programs have adopted planned, structural, repetitive and purposeful approach that includes elements of exercise, nutritional and psychological. | Behavioural | Prehabilitation group |
| ERAS protocolThe core content is to adopt a series of optimized measures performed during the perioperative period on the basis of evidence-based medical findings to reduce the physiological and psychological stress of patients and to accelerate their recovery. | Behavioural | ERAS group, Prehabilitation group |
Primary outcome
The incidence and severity of postoperative complications
Time frame: Postoperative (≤30 days after surgery)
Major postoperative complications of patients with Gastrointestinal malignancy included gastrointestinal complication, surgical site complication, respiratory complication, cardiovascular complication, thromboembolic complication, urinary complication and other complications. The severity of complications was recorded and classified according to Clavien-Dindo classification score.
5 secondary outcomes
Cardio-pulmonary function and physical capacity
Time frame: Baseline (T0), Post-intervention (up to 2 weeks), and POD 30（30 days after surgery）
Quality of life (QoL).
Time frame: Baseline (T0), Post-intervention (up to 2 weeks), and POD 30（30 days after surgery）
Detection of immune and inflammatory indicators
Time frame: Baseline (T0), Post-intervention (up to 2 weeks), and POD 30（30 days after surgery）
The postoperative other observation parameters
Time frame: Postoperative (≤30 days after surgery)
Oncological outcomes
Time frame: 3 years
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 13 Dec 2024.
- Derived from this study: PubMed 41604182Sun Y, Tian Y, Cao S, Li L, Yu W, Ding Y, Wang X, Kong Y, Wang X, Wang H, Hui X, Qu J, Wang H, Duan Q, Yang D, Zhang H, Zhou S, Liu X, Li Z, Liu Q, Zhou Y. Supervised Multimodal Prehabilitation and Clinical Outcomes in Older Patients With Frailty and Gastric Cancer: The GISSG+2201 Randomized Clinical Trial. JAMA Surg. 2026 Mar 1;161(3):223-233. doi: 10.1001/jamasurg.2025.6256.
- Derived from this study: PubMed 37816552Sun Y, Tian Y, Cao S, Li L, Yu W, Ding Y, Wang X, Kong Y, Wang X, Wang H, Hui X, Qu J, Wang H, Duan Q, Yang D, Zhang H, Zhou S, Liu X, Li Z, Meng C, Kehlet H, Zhou Y. Multimodal prehabilitation to improve the clinical outcomes of frail elderly patients with gastric cancer: a study protocol for a multicentre randomised controlled trial (GISSG+2201). BMJ Open. 2023 Oct 10;13(10):e071714. doi: 10.1136/bmjopen-2023-071714.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
Yanbing Zhou, MD study director
The Affiliated Hospital of Qingdao University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal prehabilitation program and ERAS protocol in people with Stomach Neoplasms and Frail Elderly, run by The Affiliated Hospital of Qingdao University at 1 site in China.
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 9 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 13 Dec 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 China. 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?
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?
The incidence and severity of postoperative complications (time frame: Postoperative (≤30 days after surgery)). 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 NCT05352802, which also lists 2 linked publications.
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 13 Dec 2024.