Frailty in the Elderly Oncological and Oncohematological Patient.

NCT07624370 | Enrolling By Invitation

• 2 other identifiers: 20-20245159
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Sarcopenia in Elderly; Frailty/Sarcopenia; Oncological Patients; Hematologic Disease

Outcome Measures

Primary Outcomes (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

  12 months from screening

Secondary Outcomes (2)

• Identification of Sarcopenia and Frailty through Clinical Assessment

  12 months from the screening

• Correlation of Radiological, Functional, Clinical, and Laboratory Assessments in the Diagnosis of Sarcopenia and Frailty

  12 months from screening

Study Arms (1)

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

Interventions

Frailty evaluation OTHER

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

Frail patients with solid tumors and hematologic malignancies.

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Azienda Socio Sanitaria Territoriale Ovest Milanese, Ospedale di Legnano: lead

Study Sites (1)

Trial Office-ASST Ovest Milanese

Legnano, Italy, 20025, Italy

Location

Related Publications (19)

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MeSH Terms

Conditions

Frailty; Sarcopenia; Hematologic Diseases

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: June 3, 2026
• Study Start: March 21, 2025
• Primary Completion: April 9, 2026
• Study Completion (Estimated): December 13, 2028
• Last Updated: June 8, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)