Gastric CancerNCT06521541
Whole Course Multi-model Prehabilitation to Improve Clinical Outcome in Patients Undergoing Neoadjuvant Treatment Prior to Gastrectomy
A study testing Multimodal prehabilitation program and ERAS program in people with Gastric Cancer and Prehabilitation, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial summary
The intention of research is to establish a multimodal prehabilitation protocol in patients who undergo neoadjuvant chemotherapy prior to gastrectomy, explore the feasibility and effectiveness of the measures and evaluate the effect of program on short-term clinical outcome, fitness and long-term prognosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Prehabilitation
- What is being tested?
- Multimodal prehabilitation program and ERAS program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 1 May 2025
- Phase
- Interventional
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥18 years;
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤2；
- Endoscopic biopsies were pathologically confirmed as gastric adenocarcinoma；
- The feasibility of neoadjuvant therapy was suggested by MDT, and the feasibility of radical gastrectomy was re-evaluated after neoadjuvant therapy;
- Blood routine, liver function, kidney function, heart function and lung function were normal before neoadjuvant therapy, and there was no contraindication of chemotherapy and surgery;
- The pregnancy test was negative within 1 month, and she was not pregnant or breastfeeding;
- Informed consent and ability to comply with research protocols.
Who cannot join
- metastasis;
- 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 hemorrhage, cerebral infarction, TIA or central nervous system disease or mental illness within 6 months, could not cooperate with the completion of neoadjuvant therapy and pre-rehabilitation exercise;
- Patients have severe infections (such as MODS, etc.) or have allergic reactions to chemotherapy drugs and metabolic disorders;
- Concurrent tumors or other diseases requiring simultaneous surgery (except laparoscopic gallbladder surgery);
- Emergency surgery is required due to tumor complications (e.g., bleeding, perforation, obstruction);
- Patients participating in other clinical trials.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital
Qingdao, Shandong, 266000
Yanbing Zhou, MD, 86532-82911324, zhouyanbing@qduhospital.cn
About this study
Official title: Whole Course Multi-model Prehabilitation to Improve Clinical Outcome in Patients Undergoing Neoadjuvant Treatment Prior to Gastrectomy : A Single Center Randomized Control Trial
The intention of research is to establish a multimodal prehabilitation protocol in patients who undergo neoadjuvant chemotherapy prior to gastrectomy, explore the feasibility and effectiveness of the measures and evaluate the effect of program on short-term clinical outcome, fitness and long-term prognosis.
- Conditions
- Gastric Cancer, Prehabilitation
- Being tested
- Multimodal prehabilitation program, ERAS program
- Keywords
- Multimodal prehabilitation, Neoadjuvant chemotherapy
- 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
Patients adopted planned, structural, repetitive and purposeful approach that includes elements of exercise, nutritional and psychological.Patients were evaluated for changes during neoadjuvant therapy and postoperative recovery
ERAS programBehavioural
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 |
|---|---|---|
| Multimodal prehabilitation group | Experimental | Patients received multimodal prehabilitation combined with ERAS before the gastrectomy. Receives: Behavioral: Multimodal prehabilitation program |
| ERAS group | Active comparator | The ERAS pathway was followed in patients in the ERAS group. Receives: Behavioral: ERAS program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiopulmonary capacity
The 6-minute walk test (6MWT) can be used to measure exercise capacity to reflect cardiopulmonary function.
Measured: Baseline (T0), Post-neoadjuvant chemotherapy (through completetion of neoadjuvant therapy, an average of 16 weeks), and prior to surgery(T2)
Secondary outcomes (11)
Patient's quality of life
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-neoadjuvant chemotherapy (through completetion of neoadjuvant therapy, an average of 16 weeks), and prior to surgery(T2)
Serum albumin levels
The level of Serum albumin is used to assess nurtritional status.
Measured: Baseline (T0), Post-neoadjuvant chemotherapy (through completetion of neoadjuvant therapy, an average of 16 weeks), and prior to surgery(T2)
sarcopenia
At the L3 level, total SM will be measured. Skeletal muscle index (SMI) will be calculated as follows: SM/height(m)2. SMI is used to assess nurtritional status.
Measured: Baseline (T0), Post-neoadjuvant chemotherapy (through completetion of neoadjuvant therapy, an average of 16 weeks), and prior to surgery(T2)
completetion of neoadjuvant chemotherapy
Discontinued due to adverse reactions
Measured: Post-neoadjuvant chemotherapy (through completetion of neoadjuvant therapy, an average of 16 weeks)
First exhaust and defecation
First exhaust and defecation is used to assess the postoperative recovery course.
Measured: Postoperative (≤30 days after surgery)
First liquid diet
First liquid diet is used to assess the postoperative recovery course.
Measured: Postoperative (≤30 days after surgery)
The incidence of postoperative complications
Refers to the incidence of early postoperative complications.
Measured: Postoperative (≤30 days after surgery)
Duration of postoperative hospital stay
Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.
Measured: Postoperative (≤30 days after surgery)
Hospitalization costs
The expense from admission to discharge
Measured: Postoperative (≤30 days after surgery)
3-year recurrence-free survival
3-year recurrence-free survival (RFS) rate
Measured: 3 years
3-year overall survival
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 posted26 Jul 2024
- Study start1 Jun 2024
- Primary completion1 Jan 2025 (estimated)
- Study completion1 May 2025 (estimated)
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 Gastric CancerStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yanbing Zhou, Study director, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06521541
- Sponsor's protocol ID
- Prehab2024-01
- Status last verified
- Jul 2024
- First submitted
- 14 Jul 2024
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Liu Q, Meng C, Cao S, Liu X, Tian Y, Li Z, Han L, Wang Q, Liu Z, Lv J, Liu N, Ji Q, Jiang Y, Han H, Zhao L, Niu Z, Jiang H, Sun Y, Liu G, Zhong H, Wang K, Zhou Y. The whole-course of supervised home-based multi-modal prehabilitation to improve clinical outcome in patients undergoing neoadjuvant chemotherapy prior to gastrectomy: a single-center randomized controlled trial. Gastric Cancer. 2026 May;29(3):669-679. doi: 10.1007/s10120-026-01735-w. Epub 2026 Mar 23.
PubMed 41870736