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Sarcopenia in ElderlySALICENCT07624370

Frailty in the Elderly Oncological and Oncohematological Patient.

An observational study of Sarcopenia in Elderly and Frailty/Sarcopenia, run by Azienda Socio Sanitaria Territoriale Ovest Milanese, Ospedale di Legnano at 1 site in Italy.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 70 years and older
What is being tested?
Frailty evaluation
How many people
160 participants
Where
1 siteItaly
Study dates
21 Mar 2025to 13 Dec 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

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.

Who may be able to join

  • 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
Show all 12Show fewer
  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Italy1 site
  • Trial Office-ASST Ovest Milanese

    Legnano, Italy, 20025

Other trials in Italy

About this study

Official title: 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.

Being tested
Frailty evaluation
Medical subject headings
Frailty, Sarcopenia, Hematologic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Frailty evaluationOther

    Evaluation of the frailty impact on the toxicity grade 3-4 in patients undergoing chemotherapy treatment.

Study groups in NCT07624370
Study groupRoleWhat they receive
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.
Receives: Other: Frailty evaluation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 12 months from screening

Secondary outcomes (2)
  1. 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.

    Measured: 12 months from the screening

  2. 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.

    Measured: 12 months from screening

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2026
  2. Study start21 Mar 2025
  3. Primary completion9 Apr 2026
  4. Study completion13 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07624370
Sponsor's protocol ID
20-2024
Other IDs
5159
Acronym
SALICE
Status last verified
Mar 2026
First submitted
29 May 2026
Last updated
8 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Given B, Given C, Azzouz F, Stommel M. Physical functioning of elderly cancer patients prior to diagnosis and following initial treatment. Nurs Res. 2001 Jul-Aug;50(4):222-32. doi: 10.1097/00006199-200107000-00006.

    PubMed 11480531
  • Coulson AB, Royle KL, Pawlyn C, Cairns DA, Hockaday A, Bird J, Bowcock S, Kaiser M, de Tute R, Rabin N, Boyd K, Jones J, Parrish C, Gardner H, Meads D, Dawkins B, Olivier C, Henderson R, Best P, Owen R, Jenner M, Kishore B, Drayson M, Jackson G, Cook G. Frailty-adjusted therapy in Transplant Non-Eligible patients with newly diagnosed Multiple Myeloma (FiTNEss (UK-MRA Myeloma XIV Trial)): a study protocol for a randomised phase III trial. BMJ Open. 2022 Jun 2;12(6):e056147. doi: 10.1136/bmjopen-2021-056147.

    PubMed 35654466
  • Ziaaldini MM, Marzetti E, Picca A, Murlasits Z. Biochemical Pathways of Sarcopenia and Their Modulation by Physical Exercise: A Narrative Review. Front Med (Lausanne). 2017 Oct 4;4:167. doi: 10.3389/fmed.2017.00167. eCollection 2017.

    PubMed 29046874
  • Mir O, Coriat R, Blanchet B, Durand JP, Boudou-Rouquette P, Michels J, Ropert S, Vidal M, Pol S, Chaussade S, Goldwasser F. Sarcopenia predicts early dose-limiting toxicities and pharmacokinetics of sorafenib in patients with hepatocellular carcinoma. PLoS One. 2012;7(5):e37563. doi: 10.1371/journal.pone.0037563. Epub 2012 May 30.

    PubMed 22666367
  • Theermann R, Krodel A. [The spine as an unusual location for a malignant synovioma]. Z Orthop Ihre Grenzgeb. 1989 Sep-Oct;127(5):575-8. doi: 10.1055/s-2008-1040294. German.

    PubMed 2556865
  • Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13.

    PubMed 20392703
  • Williams GR, Rier HN, McDonald A, Shachar SS. Sarcopenia & aging in cancer. J Geriatr Oncol. 2019 May;10(3):374-377. doi: 10.1016/j.jgo.2018.10.009. Epub 2018 Oct 19. No abstract available.

    PubMed 30343999
  • Williams A, Baruah D, Patel J, Szabo A, Chhabra S, Dhakal B, Hari P, Janz S, Stolley M, D'Souza A. Prevalence and significance of sarcopenia in multiple myeloma patients undergoing autologous hematopoietic cell transplantation. Bone Marrow Transplant. 2021 Jan;56(1):225-231. doi: 10.1038/s41409-020-01008-9. Epub 2020 Jul 30.

    PubMed 32732941
  • Prado CM, Baracos VE, McCargar LJ, Reiman T, Mourtzakis M, Tonkin K, Mackey JR, Koski S, Pituskin E, Sawyer MB. Sarcopenia as a determinant of chemotherapy toxicity and time to tumor progression in metastatic breast cancer patients receiving capecitabine treatment. Clin Cancer Res. 2009 Apr 15;15(8):2920-6. doi: 10.1158/1078-0432.CCR-08-2242. Epub 2009 Apr 7.

    PubMed 19351764
  • Nestor KE Jr, Emmerson DA, Anthony NB, Nestor KE. Research note: lack of an effect of high levels of menadione on tumor development in Japanese quail females. Poult Sci. 1991 Nov;70(11):2382-5. doi: 10.3382/ps.0702382.

    PubMed 1754553
  • Cespedes Feliciano EM, Lee VS, Prado CM, Meyerhardt JA, Alexeeff S, Kroenke CH, Xiao J, Castillo AL, Caan BJ. Muscle mass at the time of diagnosis of nonmetastatic colon cancer and early discontinuation of chemotherapy, delays, and dose reductions on adjuvant FOLFOX: The C-SCANS study. Cancer. 2017 Dec 15;123(24):4868-4877. doi: 10.1002/cncr.30950. Epub 2017 Sep 7.

    PubMed 28881381
  • Shachar SS, Deal AM, Weinberg M, Nyrop KA, Williams GR, Nishijima TF, Benbow JM, Muss HB. Skeletal Muscle Measures as Predictors of Toxicity, Hospitalization, and Survival in Patients with Metastatic Breast Cancer Receiving Taxane-Based Chemotherapy. Clin Cancer Res. 2017 Feb 1;23(3):658-665. doi: 10.1158/1078-0432.CCR-16-0940. Epub 2016 Aug 3.

    PubMed 27489287
  • Wannamethee SG, Atkins JL. Muscle loss and obesity: the health implications of sarcopenia and sarcopenic obesity. Proc Nutr Soc. 2015 Nov;74(4):405-12. doi: 10.1017/S002966511500169X. Epub 2015 Apr 27.

    PubMed 25913270
  • Adler AJ, Berlyne GM. Silicon metabolism. II. Renal handling in chronic renal failure patients. Nephron. 1986;44(1):36-9. doi: 10.1159/000183909.

    PubMed 3748249
  • Keller K, Engelhardt M. Strength and muscle mass loss with aging process. Age and strength loss. Muscles Ligaments Tendons J. 2014 Feb 24;3(4):346-50. eCollection 2013 Oct.

    PubMed 24596700

Questions about this trial

What is this clinical trial studying?

An observational study of Sarcopenia in Elderly and Frailty/Sarcopenia, run by Azienda Socio Sanitaria Territoriale Ovest Milanese, Ospedale di Legnano at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Impact of frailty on grade 3-4 Chemotherapy Toxicity in Patients with Solid and Hematologic Malignancies. (time frame: 12 months from screening). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07624370, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.

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