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NCT Number: NCT07167082

Integrated Bedside Assessment and Prognosis in Hospitalized Patients With Metastatic Cancer

This prospective observational cohort study aims to evaluate whether integrated bedside assessment of handgrip strength, cachexia-related indices, body composition, and patient-reported outcomes improves short-term prognostic stratification in hospitalized patients with metastatic cancer. Handgrip strength is a simple, rapid, and non-invasive measure of muscle function and physical reserve, and it is increasingly recognized as an indicator of frailty, sarcopenia, nutritional status, and cancer cachexia. In addition to handgrip strength, this study evaluates the prognostic value of the handgrip strength-cachexia index, bioelectrical impedance analysis-derived body composition parameters, the CRP-triglyceride-glucose index, and validated patient-reported outcome measures. The study will examine whether these admission-time assessments are associated with 30-day all-cause mortality, 90-day all-cause mortality, and 30-day unplanned hospital readmission.

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Key information

Conditions

Cancer Atrophy Body Weight Body Weight Changes Cachexia Cachexia; Cancer; Sarcopenia Hospitalizations Malnutrition Muscular Atrophy Neoplasms Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms Thinness Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Etlik City Hospital, Medical Oncology Department

Ankara, Yenimahalle, 06210, Turkey (Türkiye)

About this study

Handgrip strength declines with age and is associated with frailty, sarcopenia, cancer cachexia, nutritional deterioration, and adverse clinical outcomes in patients with cancer. In this prospective observational cohort study, consecutive adult patients with histologically or cytologically confirmed metastatic solid malignancies undergoing unplanned hospitalization will be assessed at the time of admission. Handgrip strength will be measured within the first 48 hours of admission using a calibrated hydraulic hand dynamometer. Measurements will be performed on the dominant hand, with patients seated, the elbow flexed at 90 degrees, and the wrist in a neutral position, according to standardized procedures. Three consecutive measurements will be obtained, and the highest value will be recorded for analysis.

In addition to handgrip strength, admission-time assessments will include routine laboratory parameters, the handgrip strength-cachexia index, the CRP-triglyceride-glucose index, bioelectrical impedance analysis-derived body composition measures, and validated patient-reported outcome instruments, including SARC-F, FACT-G, PSQI, PG-SGA, visual analogue scale pain score, and visual analogue scale appetite score. Patients will be followed for short-term clinical outcomes, including 30-day all-cause mortality, 90-day all-cause mortality, and 30-day unplanned hospital readmission after index discharge.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults aged 18 years and older
  • Pathologically confirmed diagnosis of cancer
  • Hospitalized with an expected hospital stay of more than 48 hours
  • Ability to provide written informed consent

Exclusion criteria

  • Diagnosis of anorexia nervosa
  • Acute pancreatitis or acute liver failure at admission
  • History of gastric bypass surgery
  • Presence of chronic active infections
  • History of solid organ transplantation
  • Pregnant or breastfeeding women

Treatment and study plan

Hand Grip Strength Measurement

Other

Hand grip strength will be measured within the first 24 hours of hospitalization using a calibrated hand dynamometer. Measurements will be performed on the dominant hand, with patients seated, following standardized international procedures. Three consecutive measurements will be obtained, and the average value will be recorded. The test is non-invasive, quick, and performed by oncology clinicians trained in the protocol.

Primary outcomes

  1. 30-day All-Cause Mortality

    Time frame: 30 days after hospital admission

    All-cause mortality within 30 days of hospital admission among cancer patients (Yes/No). Mortality status will be assessed through hospital records and follow-up. Hand grip strength values will be analyzed in relation to mortality risk.

Secondary outcomes

  1. Intensive Care Unit Admission

    Time frame: 30 days after hospital admission

    Number of patients requiring ICU admission within 30 days of hospital admission (Yes/No).

  2. Hospital Readmission

    Time frame: 30 days after discharge

    All-cause hospital readmission within 30 days of discharge (Yes/No).

  3. Functional Decline - ECOG Performance Status

    Time frame: Baseline and 30 days after hospital admission

    Decline in functional status assessed by the Eastern Cooperative Oncology Group (ECOG) Performance Status (range 0-4; 0 = fully active, 1 = restricted in strenuous activity, 2 = ambulatory but unable to work, 3 = limited self-care, 4 = completely disabled; higher score = worse performance), comparing baseline and 30-day follow-up.

  4. Length of Hospital Stay

    Time frame: Through initial hospitalization, up to 30 days

    Duration of initial hospitalization, measured in days from admission to discharge.

  5. Major Complications

    Time frame: 30 days after hospital admission

    Incidence of major complications including hospital-acquired infection, respiratory failure, cardiovascular events, acute renal failure, or gastrointestinal failure within 30 days (Yes/No).

  6. Functional Decline - Patient-Generated Subjective Global Assessment (PG-SGA)

    Time frame: Baseline and 30 days after hospital admission

    Decline in nutritional status assessed by the Patient-Generated Subjective Global Assessment (PG-SGA) Score (range 0-35; 0-1 = no intervention required, 2-3 = patient/family education, 4-8 = requires dietitian intervention, ≥9 = critical need for nutritional intervention and/or symptom management; higher score = worse nutritional status), comparing baseline and 30-day follow-up.

Sponsors and collaborators

Lead sponsor

Ankara Etlik City Hospital

Other Gov

Registry information

Official study title

Integrated Assessment of Cachexia, Body Composition, and Patient-Reported Outcomes in Unplanned Hospitalizations of Metastatic Cancer Patients: The PRO-HAND Study

Acronym: PRO-HAND

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 11, 2025
Registry last updated
Jul 1, 2026

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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