Clinical trial NCT06521541: Whole Course Multi-model Prehabilitation to Improve Clinical Outcome in Patients Undergoing Neoadjuvant Treatment Prior to Gastrectomy
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastric Cancer
Prehabilitation
Keywords: Multimodal prehabilitation
Neoadjuvant chemotherapy
Lead sponsor: The Affiliated Hospital of Qingdao University
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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.

Primary outcomes:
measure: Cardiopulmonary capacity
timeFrame: Baseline (T0), Post-neoadjuvant chemotherapy (through completetion of neoadjuvant therapy, an average of 16 weeks), and prior to surgery(T2)
Secondary outcomes:
measure: Patient's quality of life
timeFrame: Baseline (T0), Post-neoadjuvant chemotherapy (through completetion of neoadjuvant therapy, an average of 16 weeks), and prior to surgery(T2)
measure: Serum albumin levels
timeFrame: Baseline (T0), Post-neoadjuvant chemotherapy (through completetion of neoadjuvant therapy, an average of 16 weeks), and prior to surgery(T2)
measure: sarcopenia
timeFrame: Baseline (T0), Post-neoadjuvant chemotherapy (through completetion of neoadjuvant therapy, an average of 16 weeks), and prior to surgery(T2)
measure: completetion of neoadjuvant chemotherapy
timeFrame: Post-neoadjuvant chemotherapy (through completetion of neoadjuvant therapy, an average of 16 weeks)
measure: First exhaust and defecation
timeFrame: Postoperative (≤30 days after surgery)
measure: First liquid diet
timeFrame: Postoperative (≤30 days after surgery)
measure: The incidence of postoperative complications
timeFrame: Postoperative (≤30 days after surgery)
measure: Duration of postoperative hospital stay
timeFrame: Postoperative (≤30 days after surgery)
measure: Hospitalization costs
timeFrame: Postoperative (≤30 days after surgery)
measure: 3-year recurrence-free survival
timeFrame: 3 years
measure: 3-year overall survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital
state: Shandong
Study officials:
affiliation: The Affiliated Hospital of Qingdao University
name: Yanbing Zhou
role: STUDY_DIRECTOR
References: