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Integrated Bedside Assessment and Prognosis in Hospitalized Patients With Metastatic Cancer

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07167082
Acronym
PRO-HAND
Enrollment
233
Registered
2025-09-11
Start date
2024-09-01
Completion date
2025-03-25
Last updated
2026-07-01

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

Conditions

Cachexia; Cancer; Sarcopenia, Cancer, Hospitalizations, Sarcopenia

Keywords

Hand Grip Strength, Prognosis, Hospitalized Cancer Patients, Cachexia, Malnutrition, Functional Decline, Mortality

Brief summary

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.

Detailed description

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.

Interventions

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.

Sponsors

Ankara Etlik City Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

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

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

Design outcomes

Primary

MeasureTime frameDescription
30-day All-Cause Mortality30 days after hospital admissionAll-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

MeasureTime frameDescription
Intensive Care Unit Admission30 days after hospital admissionNumber of patients requiring ICU admission within 30 days of hospital admission (Yes/No).
Hospital Readmission30 days after dischargeAll-cause hospital readmission within 30 days of discharge (Yes/No).
Functional Decline - ECOG Performance StatusBaseline and 30 days after hospital admissionDecline 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.
Length of Hospital StayThrough initial hospitalization, up to 30 daysDuration of initial hospitalization, measured in days from admission to discharge.
Major Complications30 days after hospital admissionIncidence of major complications including hospital-acquired infection, respiratory failure, cardiovascular events, acute renal failure, or gastrointestinal failure within 30 days (Yes/No).
Functional Decline - Patient-Generated Subjective Global Assessment (PG-SGA)Baseline and 30 days after hospital admissionDecline 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.

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORGalip Can Uyar, MD

Ankara Etlik City Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 2, 2026