- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07405307
Sarcopenia Risk Screening in Patients With Gastrointestinal Cancer Using SARC-F
Evaluation of the Proportion of Patients With Gastrointestinal Cancer Who Have Symptoms of Sarcopenia
Sarcopenia is a syndrome characterized by progressive loss of skeletal muscle mass and strength and is associated with worse outcomes in cancer patients. It can negatively affect prognosis, increase postoperative complications, reduce tolerance to systemic therapy, and impair quality of life. Sarcopenia may be present even in patients with preserved nutritional status or overweight.
This study evaluated the proportion of patients with gastrointestinal cancer who were at risk of sarcopenia, as assessed by the SARC-F screening questionnaire, before initiation of systemic treatment and during treatment. Patients with a positive screening result could be referred for further nutritional evaluation and assessment of sarcopenia severity using anthropometric measurements and DXA, according to standard clinical practice.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Sarcopenia is a complex condition characterized by progressive and generalized loss of skeletal muscle mass and strength. In oncology patients, sarcopenia is associated with increased mortality, higher rates of postoperative complications, reduced response to systemic therapy, increased treatment-related toxicity, and decreased quality of life. Sarcopenia may occur independently of malnutrition and may also be present in patients with normal or increased body weight.
Sarcopenia is not only related to the presence of malignant disease but may also develop or worsen as a consequence of oncological treatment. Several antineoplastic therapies have been shown to negatively affect muscle mass and function.
Due to its significant negative clinical impact, early detection of sarcopenia risk is essential. The SARC-F questionnaire is a validated screening tool recommended by the European Working Group on Sarcopenia in Older People (EWGSOP2) for identifying individuals at risk of sarcopenia.
This prospective observational cohort study evaluated the proportion of patients with gastrointestinal cancers treated at the Institute of Oncology Ljubljana who screened positive for sarcopenia risk using the SARC-F questionnaire before initiation of systemic treatment and during treatment. The study also assessed changes in the proportion of patients at risk over time.
Patients with a positive SARC-F screening result could be referred to the Clinical Nutrition Outpatient Clinic for further evaluation, including anthropometric measurements and DXA assessment, in order to determine the severity of sarcopenia. Based on clinical evaluation and in agreement with the treating oncologist, multimodal and multidisciplinary preventive and therapeutic interventions could be introduced as part of routine clinical care.
The study was conducted over a two-year period.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Ljubljana, Slovenia, 1000
- Institute of Oncology Ljubljana
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult patients (≥18 years) with gastrointestinal cancer
- Patients planned for or receiving systemic anticancer treatment (adjuvant treatment or treatment of metastatic disease)
- Ability to complete the SARC-F screening questionnaire
- Written informed consent provided
Exclusion Criteria:
- Patients younger than 18 years
- Patients unable to complete the questionnaire (e.g., severe cognitive impairment or inability to cooperate)
- Patients not eligible for systemic anticancer treatment
- Refusal to participate in the study
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Gastrointestinal Cancer Patients
Patients with gastrointestinal cancer receiving systemic treatment (adjuvant or metastatic setting) at the Institute of Oncology Ljubljana.
Participants will be screened for sarcopenia risk using the SARC-F questionnaire at baseline and during treatment.
|
Participants with a positive SARC-F screening result will be referred to the Clinical Nutrition Outpatient Clinic for further assessment of sarcopenia using anthropometric measurements and DXA, and for implementation of multidisciplinary interventions according to standard clinical practice.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of gastrointestinal cancer patients with positive SARC-F screening
Time Frame: Baseline (before start of systemic treatment) and during systemic treatment (after 3 months)
|
Percentage of patients with gastrointestinal cancer who screen positive for sarcopenia risk using the SARC-F questionnaire.
A SARC-F score ≥4 will be considered positive.
|
Baseline (before start of systemic treatment) and during systemic treatment (after 3 months)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Neuromuscular Manifestations
- Neoplasms by Site
- Neoplasms
- Pathological Conditions, Anatomical
- Digestive System Neoplasms
- Digestive System Diseases
- Gastrointestinal Diseases
- Muscular Atrophy
- Atrophy
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Gastrointestinal Neoplasms
- Sarcopenia
Other Study ID Numbers
- OIL-SARC-2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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