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Clinical Trials/NCT06763068
NCT06763068
Completed
Not Applicable

BIA-measured Skeletal Muscle Mass Used to Assess Frailty in Older Gastric Cancer Patients

Nanjing Medical University1 site in 1 country575 target enrollmentMarch 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gastric (Stomach) Cancer
Sponsor
Nanjing Medical University
Enrollment
575
Locations
1
Primary Endpoint
Skeletal muscle mass
Status
Completed
Last Updated
last year

Overview

Brief Summary

The primary aim of this study was to quantify the diagnosis of pre-surgical skeletal muscle mass in elderly gastric cancer patients and to analyse its correlation with frailty. The second aim was to investigate whether skeletal muscle mass, or sarcopenia, is associated with mobility and nutritional status, and anxiety and depression. The main questions it aims to answer are whether skeletal muscle mass is significantly associated with frailty and whether it can be used as a brief screening tool for preoperative frailty.

Registry
clinicaltrials.gov
Start Date
March 1, 2021
End Date
December 31, 2022
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Nanjing Medical University
Responsible Party
Principal Investigator
Principal Investigator

Yinning Guo

PhD student

Nanjing Medical University

Eligibility Criteria

Inclusion Criteria

  • diagnosed with gastric cancer by endoscopy or pathology; age \>60 years old; radical gastrectomy was proposed; be able to communicate simply in writing and verbal.

Exclusion Criteria

  • received preoperative radiotherapy or chemotherapy; combined with other sites of malignant tumors; combined with severe heart, liver, lung and renal insufficiency; recent using hormones, immunosuppressants; with physical disabilities.

Outcomes

Primary Outcomes

Skeletal muscle mass

Time Frame: Within 24 hours of admission

Skeletal muscle mass was measured by bioelectrical impedance analysis(BIA) and was classified as sarcopenia if it was less than 7.0 kg/m2 in men and 5.7 kg/m2 in women.

frailty

Time Frame: Within 24 hours of admission and discharge

The Tilburg frailty scale was used to assess the frailty of older people with gastric cancer. The Tilburg frailty scale was compiled by Gobbens et al. The scale contains 15 items in three dimensions of physical, psychological and social frailty. The total score of the scale is 0-15 points and the cut-off value of the total scale was 5, with higher score indicating more severe frailty.

Secondary Outcomes

  • Nutritional Status(Within 24 hours of admission and discharge)
  • anxiety and depression(Within 24 hours of admission and discharge)

Study Sites (1)

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