- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07167082
- Original Trial
Hand Grip Strength and Prognosis in Hospitalized Cancer Patients (PRO-HAND)
September 3, 2025 updated by: Galip Can Uyar, Ankara Etlik City Hospital
Hospitalized Cancer Patients: Prognostic Value of Hand Grip Strength - A Prospective Cohort Study
This prospective cohort study aims to investigate the relationship between hand grip strength and prognosis in hospitalized cancer patients.
Hand grip strength, a simple, rapid, and non-invasive measure of overall muscle function, is increasingly recognized as an indicator of frailty, nutritional status, and physical health.
The study will evaluate whether lower hand grip strength is associated with higher short-term mortality (30-day all-cause mortality) and adverse clinical outcomes, including ICU admission, hospital readmission, and functional decline.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Hand grip strength declines with age and is associated with frailty, sarcopenia, and cancer cachexia.
It is a reliable prognostic marker in cancer patients.
In this prospective cohort study, hospitalized patients with pathologically confirmed cancer will undergo hand grip strength measurement within the first 24 hours of admission using a calibrated hand dynamometer.
Measurements will be performed on the dominant hand, with patients seated, following international standardized procedures.
Three consecutive measurements will be obtained, and the average value will be recorded.
Assessments will be conducted by oncology clinicians trained in the protocol.
Patients will be followed for 30 days to evaluate primary and secondary endpoints, including all-cause mortality, functional decline, length of hospital stay, intensive care unit admission, readmission, and major complications.
Study Type
Observational
Enrollment (Actual)
130
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Yenimahalle
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Ankara, Yenimahalle, Turkey (Türkiye), 06210
- Etlik City Hospital, Medical Oncology Department
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
The study population consists of adult patients aged 18 years and older with pathologically confirmed cancer who are admitted to the Ankara Etlik City Hospital, Department of Medical Oncology.
Eligible participants are hospitalized for more than 48 hours and undergo hand grip strength measurement within 24 hours of admission.
Patients represent a heterogeneous group of solid tumor cases across different cancer types and stages, reflecting a real-world hospitalized oncology population.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Hospitalized Cancer Patients
This cohort consists of adult patients (aged 18-80 years) with pathologically confirmed cancer who are admitted to the hospital for at least 48 hours.
Hand grip strength is measured within the first 24 hours of admission using a standardized dynamometer protocol.
Patients are followed prospectively for 30 days to evaluate primary and secondary outcomes including all-cause mortality, functional decline, hospital stay duration, readmission, and major complications.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
30 days after hospital admission
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
30 days after hospital admission
|
|
Hospital Readmission
Time Frame: 30 days after discharge
|
All-cause hospital readmission within 30 days of discharge (Yes/No).
|
30 days after discharge
|
|
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.
|
Baseline and 30 days after hospital admission
|
|
Length of Hospital Stay
Time Frame: Through initial hospitalization, up to 30 days
|
Duration of initial hospitalization, measured in days from admission to discharge.
|
Through initial hospitalization, up to 30 days
|
|
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).
|
30 days after hospital admission
|
|
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.
|
Baseline and 30 days after hospital admission
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Galip Can Uyar, MD, Ankara Etlik City Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2024
Primary Completion (Actual)
October 20, 2024
Study Completion (Actual)
March 25, 2025
Study Registration Dates
First Submitted
August 23, 2025
First Submitted That Met QC Criteria
September 3, 2025
First Posted (Estimated)
September 11, 2025
Study Record Updates
Last Update Posted (Estimated)
September 11, 2025
Last Update Submitted That Met QC Criteria
September 3, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Neuromuscular Manifestations
- Nutrition Disorders
- Pathological Conditions, Anatomical
- Body Weight
- Body Weight Changes
- Muscular Atrophy
- Atrophy
- Weight Loss
- Thinness
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Malnutrition
- Neoplasms
- Sarcopenia
- Cachexia
Other Study ID Numbers
- AEŞH-BADEK-2024-1105 (Other Identifier: Ankara Etlik City Hospital Ethics Committee)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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