An observational study in Sarcopenia in Elderly, Frailty/Sarcopenia and Oncological Patients, sponsored by Azienda Socio Sanitaria Territoriale Ovest Milanese, Ospedale di Legnano. Enrolling by invitation at 1 site in Italy. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2026-06-08.
Sponsored by Azienda Socio Sanitaria Territoriale Ovest Milanese, Ospedale di Legnano · Observational
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.
1,284 studies on the registry are indexed under Frailty; 452 are open to participants now.
This study's planned enrollment of 160 is below the median of 225 across 493 observational studies indexed under Frailty.
Browse Frailty studies →Azienda Socio Sanitaria Territoriale Ovest Milanese, Ospedale di Legnano is the lead sponsor of 5 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Inclusion Criteria:
Inclusion criteria for patients with solid tumors:
Inclusion criteria for patients with hematologic :
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Impact of frailty on grade 3-4 Chemotherapy Toxicity in Patients with Solid and Hematologic Malignancies.
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. Multidimensional geriatric assessment including: G8 (0-17): ≤14 = frail/vulnerable; \>14 = normal. IADL (0-8): higher scores indicate greater independence. CCI: 0-2 = low comorbidity; ≥3 = high comorbidity burden. SPPB (0-12): 10-12 = good, 7-9 = intermediate, ≤6 = poor physical performance. MUST: 0 = low, 1 = medium, ≥2 = high risk of malnutrition. Mini-Cog (0-5): ≥3 = normal cognition; \<3 = cognitive impairment. CARG: low, intermediate, or high risk of severe chemotherapy toxicity. MNA: ≥24 = normal; 17-23.5 = at risk of malnutrition; \<17 = malnourished. Laboratory tests: routine pre-chemotherapy assessments according to institutional standards. BIA: evaluation of body composition, muscle mass, and phase angle. CT/MRI: assessment of muscle area at L3/L4; sarcopenia defined as \<4.8 cm²/m² in women and \<6.6 cm²/m² in men
Time frame: 12 months from screening
Identification of Sarcopenia and Frailty through Clinical Assessment
Agreement between CT/MRI and BIA for sarcopenia diagnosis and association with geriatric and laboratory parameters. G8 (0-17): ≤14 = frail/vulnerable; \>14 = normal. IADL (0-8): higher scores indicate greater independence. CCI: 0-2 = low comorbidity; ≥3 = high comorbidity burden. SPPB (0-12): 10-12 = good, 7-9 = intermediate, ≤6 = poor physical performance. MUST: 0 = low, 1 = medium, ≥2 = high risk of malnutrition. Mini-Cog (0-5): ≥3 = normal cognition; \<3 = cognitive impairment. CARG: low, intermediate, or high risk of severe chemotherapy toxicity. MNA: ≥24 = normal; 17-23.5 = at risk of malnutrition; \<17 = malnourished. Laboratory tests: routine pre-chemotherapy assessments according to institutional standards. BIA: evaluation of body composition, muscle mass, and phase angle. CT/MRI: assessment of muscle area at L3/L4; sarcopenia defined as \<4.8 cm²/m² in women and \<6.6 cm²/m² in men.
Time frame: 12 months from the screening
Correlation of Radiological, Functional, Clinical, and Laboratory Assessments in the Diagnosis of Sarcopenia and Frailty
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.
Time frame: 12 months from screening
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Azienda Socio Sanitaria Territoriale Ovest Milanese, Ospedale di Legnano