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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06763068
Enrollment
575
Registered
2025-01-08
Start date
2021-03-01
Completion date
2022-12-31
Last updated
2025-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frailty, Gastric (Stomach) Cancer, Malnutrition Elderly, Sarcopenia

Keywords

gastric cancer, skeletal muscle mass, frailty, sarcopenia

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.

Interventions

OTHERSkeletal muscle mass and frailty

Measurement correlation variable

Sponsors

Nanjing Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Skeletal muscle massWithin 24 hours of admissionSkeletal 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.
frailtyWithin 24 hours of admission and dischargeThe 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

MeasureTime frameDescription
Nutritional StatusWithin 24 hours of admission and dischargeThe 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 depressionWithin 24 hours of admission and dischargeAnxiety 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026