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Trial Title:
Whole Course Multi-model Prehabilitation to Improve Clinical Outcome in Patients Undergoing Neoadjuvant Treatment Prior to Gastrectomy
NCT ID:
NCT06521541
Condition:
Gastric Cancer
Prehabilitation
Conditions: Official terms:
Stomach Neoplasms
Conditions: Keywords:
Multimodal prehabilitation
Neoadjuvant chemotherapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Behavioral
Intervention name:
Multimodal prehabilitation program
Description:
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
Arm group label:
Multimodal prehabilitation group
Intervention type:
Behavioral
Intervention name:
ERAS program
Description:
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.
Arm group label:
ERAS group
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Aged ≥18 years;
2. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2；
3. Endoscopic biopsies were pathologically confirmed as gastric adenocarcinoma；
4. The feasibility of neoadjuvant therapy was suggested by MDT, and the feasibility of
radical gastrectomy was re-evaluated after neoadjuvant therapy;
5. 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;
6. The pregnancy test was negative within 1 month, and she was not pregnant or
breastfeeding;
7. Informed consent and ability to comply with research protocols.
Exclusion Criteria:
1. metastasis;
2. 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;
3. 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;
4. Patients have severe infections (such as MODS, etc.) or have allergic reactions to
chemotherapy drugs and metabolic disorders;
5. Concurrent tumors or other diseases requiring simultaneous surgery (except
laparoscopic gallbladder surgery);
6. Emergency surgery is required due to tumor complications (e.g., bleeding,
perforation, obstruction);
7. Patients participating in other clinical trials.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital
Address:
City:
Qingdao
Zip:
266000
Country:
China
Status:
Recruiting
Contact:
Last name:
Yanbing Zhou, MD
Phone:
86532-82911324
Email:
zhouyanbing@qduhospital.cn
Start date:
June 1, 2024
Completion date:
May 1, 2025
Lead sponsor:
Agency:
The Affiliated Hospital of Qingdao University
Agency class:
Other
Source:
The Affiliated Hospital of Qingdao University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06521541
