Frailty in the Elderly Oncological and Oncohematological Patient. (SALICE)

May 29, 2026 updated by: Azienda Socio Sanitaria Territoriale Ovest Milanese, Ospedale di Legnano

Impatto Della Diagnosi di fragilità Sulla tossicità da Terapia in Pazienti Anziani Affetti da Tumore oncoLogIco e onCoEmatologico.

The Italian population is progressively aging, and cancer incidence increases with age. Older patients are at higher risk of frailty, a condition associated with adverse outcomes such as disability, falls, hospitalization, and mortality.

Key indicators of frailty include reduced balance, impaired physical activity, cognitive decline, and particularly sarcopenia, defined as the progressive loss of skeletal muscle mass and strength. After age 60, muscle mass decreases by 1.4-2.5% annually, while muscle strength declines by 15% between ages 60-70 and by up to 30% per decade thereafter.

Sarcopenia increases the risk of falls, fractures, hospitalization, and non-cancer-related death. In cancer patients, its prevalence ranges from 11% to 74% and is associated with poorer survival outcomes in both early and advanced disease stages.In clinical oncology practice, several tools are available to assess frailty, identify vulnerable patients, and personalize care, treatment, and supportive interventions.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

160

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

  • Italy
    • Italy
      • Legnano, Italy, Italy, 20025
        • Trial Office-ASST Ovest Milanese

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

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who are about to initiate first-line treatment, or who have received a maximum of two cycles of therapy for advanced/metastatic disease or a hematologic malignancy, will be assessed for eligibility for study enrollment. The type of oncologic or hematologic treatment will be selected by the investigator according to good clinical practice and in accordance with national and international guidelines.

Description

Inclusion Criteria:

Inclusion criteria for patients with solid tumors:

  • Cytological or histological diagnosis of lung cancer or gastrointestinal tract tumors (esophageal, gastric, intestinal, colorectal, pancreatic, and biliary tract cancers), mesothelioma.
  • Age ≥ 70 years
  • Patients deemed eligible, at the investigator's discretion, for first-line treatment including at least one chemotherapeutic agent
  • Previous treatments (e.g., adjuvant therapy) are allowed if completed at least one year prior to randomization
  • ECOG performance status 0, 1, or 2
  • Written informed consent obtained

Inclusion criteria for patients with hematologic malignancies:

  • Cytological or histological diagnosis of multiple myeloma or lymphoma
  • Age ≥ 70 years
  • Patients deemed eligible, at the investigator's discretion, for first-line systemic treatment
  • ECOG performance status 0, 1, 2, or 3
  • Written informed consent obtained

Exclusion Criteria:

  • Brain metastases (in solid tumors)
  • Symptomatic bone lesions (in solid tumors)
  • Cardiac disease classified as NYHA class III or IV
  • Current or prior prostate or breast cancer receiving hormonal therapy (GnRH agonists or antagonists, androgen inhibitors, estrogen inhibitors)
  • Acute leukemia
  • Patients with pacemakers or implantable cardioverter-defibrillators (ICD)

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
Frail patients with solid tumors and hematologic malignancies.
This cohort includes frail patients diagnosed with solid tumors or hematologic malignancies, to evaluate the impact of frailty on clinical outcome.
Other: Frailty evaluation
Evaluation of the frailty impact on the toxicity grade 3-4 in patients undergoing chemotherapy treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of Frailty on Chemotherapy Toxicity in cancer
Time Frame: 12 months from the screening
Association Between Frailty and Grade 3-4 Chemotherapy Toxicity in Patients With Solid and Hematologic Malignancies.
12 months from the screening
Impact of frailty on grade 3-4 Chemotherapy Toxicity in Patients with Solid and Hematologic Malignancies.
Time Frame: 12 months from screening
Evaluation of the impact of frailty on the probability of grade 3 or 4 toxicity in patients with solid or hematologic malignancies undergoing chemotherapy treatment.
12 months from screening

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of Sarcopenia and Frailty through Clinical Assessment
Time Frame: 12 months from the screening
Evaluation of the agreement between radiological imaging (CT/MRI) and bioimpedance analysis in the diagnosis of sarcopenia, as well as the correlation between instrumental investigations, geriatric assessment parameters, and laboratory findings for the identification of sarcopenia and frailty.
12 months from the screening
Correlation of Radiological, Functional, Clinical, and Laboratory Assessments in the Diagnosis of Sarcopenia and Frailty
Time Frame: 12 months from screening
Evaluation of the concordance between sarcopenia diagnosed through radiological imaging (CT/MRI) and that obtained through a functional assessment (bioelectrical impedance analysis), the correlation between instrumental assessments and clinical parameters (comprehensive geriatric assessment) for the diagnosis of sarcopenia/frailty, and the correlation between laboratory values and clinical-instrumental measures.
12 months from screening

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Socio Sanitaria Territoriale Ovest Milanese, Ospedale di Legnano

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

March 21, 2025

Primary Completion (Actual)

April 9, 2026

Study Completion (Estimated)

December 13, 2028

Study Registration Dates

First Submitted

May 29, 2026

First Submitted That Met QC Criteria

May 29, 2026

First Posted (Actual)

June 3, 2026

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-2024
  • 5159 (Other Identifier: COMITATO ETICO TERRITORIALE LOMBARDIA 3)

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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