Frailty in the Elderly Oncological and Oncohematological Patient. (SALICE)
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.
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Locais de estudo
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Italy
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Legnano, Italy, Itália, 20025
- Trial Office-ASST Ovest Milanese
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
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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.
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Evaluation of the frailty impact on the toxicity grade 3-4 in patients undergoing chemotherapy treatment.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Impact of frailty on grade 3-4 Chemotherapy Toxicity in Patients with Solid and Hematologic Malignancies.
Prazo: 12 months from screening
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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 |
12 months from screening
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Correlation of Radiological, Functional, Clinical, and Laboratory Assessments in the Diagnosis of Sarcopenia and Frailty
Prazo: 12 months from screening
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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.
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12 months from screening
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Identification of Sarcopenia and Frailty through Clinical Assessment
Prazo: 12 months from the screening
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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. |
12 months from the screening
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Colaboradores e Investigadores
Publicações e links úteis
Publicações Gerais
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Adler AJ, Berlyne GM. Silicon metabolism. II. Renal handling in chronic renal failure patients. Nephron. 1986;44(1):36-9. doi: 10.1159/000183909.
- Langdon RB, Freeman JA. Pharmacology of retinotectal transmission in the goldfish: effects of nicotinic ligands, strychnine, and kynurenic acid. J Neurosci. 1987 Mar;7(3):760-73. doi: 10.1523/JNEUROSCI.07-03-00760.1987.
- Palumbo A, Bringhen S, Mateos MV, Larocca A, Facon T, Kumar SK, Offidani M, McCarthy P, Evangelista A, Lonial S, Zweegman S, Musto P, Terpos E, Belch A, Hajek R, Ludwig H, Stewart AK, Moreau P, Anderson K, Einsele H, Durie BG, Dimopoulos MA, Landgren O, San Miguel JF, Richardson P, Sonneveld P, Rajkumar SV. Geriatric assessment predicts survival and toxicities in elderly myeloma patients: an International Myeloma Working Group report. Blood. 2015 Mar 26;125(13):2068-74. doi: 10.1182/blood-2014-12-615187. Epub 2015 Jan 27.
- Polverelli N, Tura P, Battipaglia G, Malagola M, Bernardi S, Gandolfi L, Zollner T, Zanaglio C, Farina M, Morello E, Turra A, Mohty M, Russo D. Multidimensional geriatric assessment for elderly hematological patients (>/=60 years) submitted to allogeneic stem cell transplantation. A French-Italian 10-year experience on 228 patients. Bone Marrow Transplant. 2020 Dec;55(12):2224-2233. doi: 10.1038/s41409-020-0934-1. Epub 2020 May 12.
- Fried LP, Ferrucci L, Darer J, Williamson JD, Anderson G. Untangling the concepts of disability, frailty, and comorbidity: implications for improved targeting and care. J Gerontol A Biol Sci Med Sci. 2004 Mar;59(3):255-63. doi: 10.1093/gerona/59.3.m255.
Datas de registro do estudo
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Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Estimado)
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Enviado pela primeira vez
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Atualizações de registro de estudo
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Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 20-2024
- 5159 (Outro identificador: COMITATO ETICO TERRITORIALE LOMBARDIA 3)
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