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

Completed

• Conditions: Gastric (Stomach) Cancer; Frailty; Sarcopenia; Malnutrition Elderly

• Registration Number: NCT06763068
• Lead Sponsor: Nanjing Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2025-01
• Study First Submitted: 2025-01-02
• Study First Submitted QC: 2025-01-02
• Last Update Submitted: 2025-01-02
• Study First Posted: 2025-01-08
• Last Update Posted: 2025-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 575

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Skeletal muscle mass	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	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 Outcome Measures

Name	Time	Method
Nutritional Status	Within 24 hours of admission and discharge	The Mini Nutritional Assessment Short-form (MNA SF) scale was used to assess the nutritional status of older people with gastric cancer, which was a simplified version of the MNA scale developed by Rubenstein et al\[. The total score of this scale is 14, 12\~14 points indicate normal nutrition, 8\~11 points indicate the risk of nutrition, ≤7 points indicate malnutrition.
anxiety and depression	Within 24 hours of admission and discharge	Anxiety and Depression in older people with gastric cancer were assessed by the Chinese version of the Hospital Anxiety and Depression Scale (HADS), which was developed by Zigmond AS et al\[23\]. The scale has 14 items, 7 of which are used to assess depressed and 7 of which are used to assess anxiety. Each item has a score of 1-4 point and a total score of more than 7 indicates the presence of anxiety or depression.

Trial Locations

Locations (1)

Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China