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Clinical Trials/NCT06521541
NCT06521541RecruitingNot Applicable

Whole Course Multi-model Prehabilitation to Improve Clinical Outcome in Patients Undergoing Neoadjuvant Treatment Prior to Gastrectomy : A Single Center Randomized Control Trial

The Affiliated Hospital of Qingdao University1 site in 1 country90 target enrollmentStarted: June 1, 2024Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
90
Locations
1
Primary Endpoint
Cardiopulmonary capacity
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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;
  • •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.

Arms & Interventions

Multimodal prehabilitation group

Experimental

Patients received multimodal prehabilitation combined with ERAS before the gastrectomy.

Intervention: Multimodal prehabilitation program (Behavioral)

ERAS group

Active Comparator

The ERAS pathway was followed in patients in the ERAS group.

Intervention: ERAS program (Behavioral)

Outcomes

Primary Outcomes

Cardiopulmonary capacity

Time Frame: Baseline (T0), Post-neoadjuvant chemotherapy (through completetion of neoadjuvant therapy, an average of 16 weeks), and prior to surgery(T2)

The 6-minute walk test (6MWT) can be used to measure exercise capacity to reflect cardiopulmonary function.

Secondary Outcomes

  • Patient's quality of life(Baseline (T0), Post-neoadjuvant chemotherapy (through completetion of neoadjuvant therapy, an average of 16 weeks), and prior to surgery(T2))
  • Serum albumin levels(Baseline (T0), Post-neoadjuvant chemotherapy (through completetion of neoadjuvant therapy, an average of 16 weeks), and prior to surgery(T2))
  • First liquid diet(Postoperative (≤30 days after surgery))
  • sarcopenia(Baseline (T0), Post-neoadjuvant chemotherapy (through completetion of neoadjuvant therapy, an average of 16 weeks), and prior to surgery(T2))
  • Duration of postoperative hospital stay(Postoperative (≤30 days after surgery))
  • 3-year recurrence-free survival(3 years)
  • 3-year overall survival(3 years)
  • First exhaust and defecation(Postoperative (≤30 days after surgery))
  • The incidence of postoperative complications(Postoperative (≤30 days after surgery))
  • completetion of neoadjuvant chemotherapy(Post-neoadjuvant chemotherapy (through completetion of neoadjuvant therapy, an average of 16 weeks))
  • Hospitalization costs(Postoperative (≤30 days after surgery))

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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