Frailty in the Elderly Oncological and Oncohematological Patient.

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

• Impact of frailty on grade 3-4 Chemotherapy Toxicity in Patients with Solid and Hematologic Malignancies. [Time frame: 12 months from screening]

Secondary outcome measures (2)

• Identification of Sarcopenia and Frailty through Clinical Assessment [Time frame: 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]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-only

Study locations

Italy · 1 center

• Trial Office-ASST Ovest Milanese — Legnano

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. PMID 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 p PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 32732941

Identifiers

NCT: NCT07624370 · 20-2024 · 5159

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗