NCT05714878

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 6, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

March 22, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

May 10, 2024

Status Verified

May 1, 2024

Enrollment Period

9 months

First QC Date

January 26, 2023

Last Update Submit

May 9, 2024

Conditions

Stomach Neoplasm

Keywords

Gastric cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

    Duke Activity Status Index score on the day before surgery

Secondary Outcomes (3)

  • Morbidity

    In postoperative 30 day after gastrectomy

  • Postoperative hospital stay

    During the postoperative 30 day period

  • 30-day readmission rate

    During the postoperative 30 day period

Study Arms (2)

Prehabilitation arm

EXPERIMENTAL

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

Behavioral: aerobic exercise; resistance exercise; nutritional support; psychological support

Control arm

NO INTERVENTION

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

Interventions

aerobic exercise; resistance exercise; nutritional support; psychological supportBEHAVIORAL

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.

Prehabilitation arm

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pathologically confirmed gastric cancer, clinical I-III TNM stage (AJCC 8th edition);
  • Will receive curative-intent surgery;
  • Life expectance \> 6 months;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital First Medical Center

Beijing, China

Location

Related Publications (2)

  • 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.

    PMID: 36017553BACKGROUND

  • 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.

    PMID: 35588252BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

ExerciseNutritional Support

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaNutrition TherapyTherapeutics

Study Officials

  • Kecheng Zhang

    Chinese PLA General Hospital First Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 26, 2023

First Posted

February 6, 2023

Study Start

March 22, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

May 10, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)