Back to results

Multimodal Prehabilitation To Improve The Clinical Outcomes Of Frail Elderly Patients With Gastric Cancer

Primary Purpose

Stomach Neoplasms, Frail Elderly

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Multimodal prehabilitation program

ERAS protocol

About this trial

This is an interventional treatment trial for Stomach Neoplasms focused on measuring Multimodal prehabilitation, ERAS

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Aged 65-85 years;
Karnofsky performance score ≥70 or Eastern Cooperative Oncology Group (ECOG) performance status score ≤2;
G8 score ≤14;
Endoscopic biopsies were pathologically confirmed as gastric adenocarcinoma;
Patients with cT1-4aN0-3M0 by endoscopy, imaging evaluations of CT and MRI, and possibility of gastric resection;
Received general anesthesia or combined spinal-epidural anesthesia (Surgery was performed by either laparotomy, laparoscopy or robotic-assisted laparoscopic);
Date of surgery ≥2 weeks from baseline (T0) assessment;
Physical conditions could meet the requirements of exercise training, and no severe concomitant disease;
All subjects had to be willing and able to comply with study protocol and were informed adequately that they maintained the right to drop out of the study at any time.

Exclusion Criteria:

Patients with uncontrolled seizure disorders, central nervous system diseases and mental disorders;
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 bleeding or infarction (within 6 months);
Patients with recurrent infection diseases or serious concomitant disease;
Patients who require synchronous surgery due to other illness;
Patients who required emergency surgery within an emergency setting (obstruction, bleeding, perforation);
Patients who are participating in any other clinical trials.

Sites / Locations

Department of Gastrointestinal Surgery, Qingdao University Affiliated HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Prehabilitation group

ERAS group

Arm Description

The prehabilitation group received multimodal prehabilitation combined with ERAS before the gastrectomy.

The ERAS group patients were treated according to the ERAS pathway.

Outcomes

Primary Outcome Measures

The incidence and severity of postoperative complications

Major postoperative complications of patients with Gastrointestinal malignancy included gastrointestinal complication, surgical site complication, respiratory complication, cardiovascular complication, thromboembolic complication, urinary complication and other complications. The severity of complications was recorded and classified according to Clavien-Dindo classification score.

Secondary Outcome Measures

Cardio-pulmonary function and physical capacity

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

Quality of life (QoL).

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.

Detection of immune and inflammatory indicators

Interleukin, Tumor necrosis factor and C-reactive protein serum concentrations

The postoperative other observation parameters

Postoperative pain severity, postoperative delirium severity and occurrence, first exhaust and defecation, ureteral catheter removal, abdominal drainage tubes removal, postoperative hospital stay, hospitalization costs, 30-day all-cause mortality and 30-day hospital readmission rate.

Oncological outcomes

3-year recurrence-free survival (RFS) rate and 3-year overall survival (OS) rate.

Full Information

NCT ID

NCT05352802

First Posted

April 18, 2022

Last Updated

April 24, 2022

Sponsor

The Affiliated Hospital of Qingdao University

Collaborators

Shandong Provincial Hospital, Qilu Hospital of Shandong University, Qianfoshan Hospital, Yantai Yuhuangding Hospital, Shandong Jining No.1 People's Hospital, Weifang Medical University, Weifang People's Hospital, Dongying People's Hospital, Weihai Municipal Hospital, Weihai Central Hospital, Rizhao People's Hospital, Liaocheng People's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05352802

Brief Title

Multimodal Prehabilitation To Improve The Clinical Outcomes Of Frail Elderly Patients With Gastric Cancer

Official Title

Multimodal Prehabilitation To Improve The Clinical Outcomes Of Frail Elderly Patients With Gastric Cancer: A Multicenter Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Recruiting

Study Start Date

May 1, 2022 (Anticipated)

Primary Completion Date

May 1, 2023 (Anticipated)

Study Completion Date

May 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Affiliated Hospital of Qingdao University

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The GISSG+2201 study was launched by Shandong Gastrointestinal Surgery Study Group (GISSG). The intention is to establish a multimodal prehabilitation protocol in frail elderly patients who undergo gastric cancer radical surgery, explore the feasibility and effectiveness of the measures and evaluate the effect of program on short-term clinical outcome, recovery index and the long-term tumor-related outcome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stomach Neoplasms, Frail Elderly

Keywords

Multimodal prehabilitation, ERAS

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

368 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Prehabilitation group

Arm Type

Experimental

Arm Description

The prehabilitation group received multimodal prehabilitation combined with ERAS before the gastrectomy.

Arm Title

ERAS group

Arm Type

Active Comparator

Arm Description

The ERAS group patients were treated according to the ERAS pathway.

Intervention Type

Behavioral

Intervention Name(s)

Multimodal prehabilitation program

Intervention Description

Multimodal prehabilitation programs have adopted planned, structural, repetitive and purposeful approach that includes elements of exercise, nutritional and psychological.

Intervention Type

Behavioral

Intervention Name(s)

ERAS protocol

Intervention 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.

Primary Outcome Measure Information:

Title

The incidence and severity of postoperative complications

Description

Time Frame

Postoperative (≤30 days after surgery)

Secondary Outcome Measure Information:

Title

Cardio-pulmonary function and physical capacity

Description

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

Time Frame

Baseline (T0), Post-intervention (up to 2 weeks), and POD 30（30 days after surgery）

Title

Quality of life (QoL).

Description

Time Frame

Baseline (T0), Post-intervention (up to 2 weeks), and POD 30（30 days after surgery）

Title

Detection of immune and inflammatory indicators

Description

Interleukin, Tumor necrosis factor and C-reactive protein serum concentrations

Time Frame

Baseline (T0), Post-intervention (up to 2 weeks), and POD 30（30 days after surgery）

Title

The postoperative other observation parameters

Description

Time Frame

Postoperative (≤30 days after surgery)

Title

Oncological outcomes

Description

3-year recurrence-free survival (RFS) rate and 3-year overall survival (OS) rate.

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Aged 65-85 years; Karnofsky performance score ≥70 or Eastern Cooperative Oncology Group (ECOG) performance status score ≤2; G8 score ≤14; Endoscopic biopsies were pathologically confirmed as gastric adenocarcinoma; Patients with cT1-4aN0-3M0 by endoscopy, imaging evaluations of CT and MRI, and possibility of gastric resection; Received general anesthesia or combined spinal-epidural anesthesia (Surgery was performed by either laparotomy, laparoscopy or robotic-assisted laparoscopic); Date of surgery ≥2 weeks from baseline (T0) assessment; Physical conditions could meet the requirements of exercise training, and no severe concomitant disease; All subjects had to be willing and able to comply with study protocol and were informed adequately that they maintained the right to drop out of the study at any time. Exclusion Criteria: Patients with uncontrolled seizure disorders, central nervous system diseases and mental disorders; 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 bleeding or infarction (within 6 months); Patients with recurrent infection diseases or serious concomitant disease; Patients who require synchronous surgery due to other illness; Patients who required emergency surgery within an emergency setting (obstruction, bleeding, perforation); Patients who are participating in any other clinical trials.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yanbing Zhou, MD

Phone

86532-82911324

zhouyanbing@qduhospital.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Yuqi Sun, MD

Phone

86532-82911324

2021010097@qdu.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yanbing Zhou, MD

Organizational Affiliation

The Affiliated Hospital of Qingdao University

Official's Role

Study Director

Facility Information:

Facility Name

Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital

City

Qingdao

State/Province

Shandong

ZIP/Postal Code

266000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yanbing Zhou, MD

Phone

86532-82911324

zhouyanbing@qduhospital.cn

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

Multimodal Prehabilitation To Improve The Clinical Outcomes Of Frail Elderly Patients With Gastric Cancer

We'll reach out to this number within 24 hrs