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Multimodal Prehabilitation for Resectable Gastric Cancer

Primary Purpose

Stomach Neoplasm

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
aerobic exercise; resistance exercise; nutritional support; psychological support
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stomach Neoplasm focused on measuring Gastric cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Pathologically confirmed gastric cancer, clinical I-III TNM stage (AJCC 8th edition); Will receive curative-intent surgery; Life expectance > 6 months; Exclusion Criteria: Gastric stump cancer or combined with other malignances; NYHA III, NYHA IV; Inability to swallow, with gastrostomy, or inability to move because of orthopedic disease or neuromuscular disease; Psychiatric disorders, COPD, end-stage hepatic or renal disease, uncontrolled cardiac arhythmia or uncontrolled hypertention; Receiving immunosuppressive therapy; Emergency surgery because of tumor bleeding or tumor perforation;

Sites / Locations

  • Chinese PLA General Hospital First Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Prehabilitation arm

Control arm

Arm Description

Patient receives prehabilitation intervention including exercise, nutrition and psychological support.

Patient receives regular care recommended by the WHO without supervision and support.

Outcomes

Primary Outcome Measures

Duke Activity Status Index before surgery
Duke Activity Status Index score is a 12-item self-reported questionnaire that assesses daily activities such as personal care, ambulation, household tasks, and recreation with respective metabolic costs. Duke Activity Status Index score ranges from 0 to 58.2. The higher score indicates the better functional status. Duke Activity Status Index has been recommended by European Society of Cardiology guidelines for functional assessment of patients undergoing non-cardiac surgery.

Secondary Outcome Measures

Morbidity
Postoperative complication
Postoperative hospital stay
Period from day of surgery to day of discharge from hospital
30-day readmission rate
Proportion of patients admitted to the hospital after discharge because of complications

Full Information

First Posted
January 26, 2023
Last Updated
March 21, 2023
Sponsor
Chinese PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05714878
Brief Title
Multimodal Prehabilitation for Resectable Gastric Cancer
Official Title
Multimodal Prehabilitation for Patients With Resectable Gastric Cancer: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 22, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Surgical resection is the mainstay for gastric cancer. Surgical stress response, like insulin resistance and catabolism, is inevitable and is a risk factor for postoperative outcome. To cope with this stress, the enhanced recovery protocol has been proposed and successfully implemented in clinical practice. Recently, prehabilitation have attracted increasingly attention, which is the preoperative part of enhanced recovery pathway. Prehabtilitation are bundles of evidenced elements in order to improve patient's functional capacity. Patients with gastric cancer are usually suffered from nutritional risk, anxiety and frailty. In this trial, we investigate whether multimodal prehabilitation (exercise, nutrition and psychological support) could improve patient's functional status to better tolerate surgical trauma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasm
Keywords
Gastric cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prehabilitation arm
Arm Type
Experimental
Arm Description
Patient receives prehabilitation intervention including exercise, nutrition and psychological support.
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
Patient receives regular care recommended by the WHO without supervision and support.
Intervention Type
Behavioral
Intervention Name(s)
aerobic exercise; resistance exercise; nutritional support; psychological support
Intervention Description
Patient with gastric cancer received two weeks of prehabilitation intervention. An individualized exercise program was established according to the FITT (Frequency, Intensity, Time and Type) principle. Aerobic exercise: 3-5 times/week, 30-60 min jogging or brisk walking per time, intensity based on heart rate and modified Borg-scale. Resistance exercise: 2-3 times/week, 10-12 RM per sets, 2-3 sets with 2 min interval rest, seated knee up, knee extension, etc. Nutritional support: 30kcal/kg/d, 1.5mg/kg/d protein, oral nutritional supplement with suggested recipes. Psychological support: provided with guidance on gastric cancer, regular online chat through Wechat, alcohol quitting, smoking cessation and light music.
Primary Outcome Measure Information:
Title
Duke Activity Status Index before surgery
Description
Duke Activity Status Index score is a 12-item self-reported questionnaire that assesses daily activities such as personal care, ambulation, household tasks, and recreation with respective metabolic costs. Duke Activity Status Index score ranges from 0 to 58.2. The higher score indicates the better functional status. Duke Activity Status Index has been recommended by European Society of Cardiology guidelines for functional assessment of patients undergoing non-cardiac surgery.
Time Frame
Duke Activity Status Index score on the day before surgery
Secondary Outcome Measure Information:
Title
Morbidity
Description
Postoperative complication
Time Frame
In postoperative 30 day after gastrectomy
Title
Postoperative hospital stay
Description
Period from day of surgery to day of discharge from hospital
Time Frame
During the postoperative 30 day period
Title
30-day readmission rate
Description
Proportion of patients admitted to the hospital after discharge because of complications
Time Frame
During the postoperative 30 day period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pathologically confirmed gastric cancer, clinical I-III TNM stage (AJCC 8th edition); Will receive curative-intent surgery; Life expectance > 6 months; Exclusion Criteria: Gastric stump cancer or combined with other malignances; NYHA III, NYHA IV; Inability to swallow, with gastrostomy, or inability to move because of orthopedic disease or neuromuscular disease; Psychiatric disorders, COPD, end-stage hepatic or renal disease, uncontrolled cardiac arhythmia or uncontrolled hypertention; Receiving immunosuppressive therapy; Emergency surgery because of tumor bleeding or tumor perforation;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kecheng Zhang, PhD
Phone
010-66938328
Email
zhangkecheng@301hospital.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kecheng Zhang
Organizational Affiliation
Chinese PLA General Hospital First Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese PLA General Hospital First Medical Center
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kecheng Zhang

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36017553
Citation
Halvorsen S, Mehilli J, Cassese S, Hall TS, Abdelhamid M, Barbato E, De Hert S, de Laval I, Geisler T, Hinterbuchner L, Ibanez B, Lenarczyk R, Mansmann UR, McGreavy P, Mueller C, Muneretto C, Niessner A, Potpara TS, Ristic A, Sade LE, Schirmer H, Schupke S, Sillesen H, Skulstad H, Torracca L, Tutarel O, Van Der Meer P, Wojakowski W, Zacharowski K; ESC Scientific Document Group. 2022 ESC Guidelines on cardiovascular assessment and management of patients undergoing non-cardiac surgery. Eur Heart J. 2022 Oct 14;43(39):3826-3924. doi: 10.1093/eurheartj/ehac270. No abstract available. Erratum In: Eur Heart J. 2023 Sep 07;:
Results Reference
background
PubMed Identifier
35588252
Citation
Molenaar CJ, van Rooijen SJ, Fokkenrood HJ, Roumen RM, Janssen L, Slooter GD. Prehabilitation versus no prehabilitation to improve functional capacity, reduce postoperative complications and improve quality of life in colorectal cancer surgery. Cochrane Database Syst Rev. 2022 May 19;5(5):CD013259. doi: 10.1002/14651858.CD013259.pub2.
Results Reference
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Multimodal Prehabilitation for Resectable Gastric Cancer

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