Whole Course Multi-model Prehabilitation to Improve Clinical Outcome in Patients Undergoing Neoad… (NCT06521541) | Clinical Trial Compass
RecruitingNot Applicable
Whole Course Multi-model Prehabilitation to Improve Clinical Outcome in Patients Undergoing Neoadjuvant Treatment Prior to Gastrectomy
China90 participantsStarted 2024-06-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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;
What they're measuring
1
Cardiopulmonary capacity
Timeframe: Baseline (T0), Post-neoadjuvant chemotherapy (through completetion of neoadjuvant therapy, an average of 16 weeks), and prior to surgery(T2)
Trial details
NCT IDNCT06521541
SponsorThe Affiliated Hospital of Qingdao University