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Completed

NCT Number: NCT06763068

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

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.

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Key information

Conditions

Gastric (Stomach) Cancer Atrophy Digestive System Diseases Digestive System Neoplasms Frailty Gastrointestinal Diseases Gastrointestinal Neoplasms Malnutrition Elderly Muscular Atrophy Neoplasms Neoplasms by Site Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms Stomach Diseases Stomach Neoplasms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nanjing Medical University

Nanjing, Jiangsu, 211166, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Skeletal muscle mass and frailty

Other

Measurement correlation variable

Primary outcomes

  1. 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.

  2. 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

  1. Nutritional Status

    Time frame: 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.

  2. anxiety and depression

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Nanjing Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 8, 2025
Registry last updated
Jan 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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