Frailty in the Elderly Oncological and Oncohematological Patient. (NCT07624370) | Clinical Trial Compass
By InvitationNot Applicable
Frailty in the Elderly Oncological and Oncohematological Patient.
Italy160 participantsStarted 2025-03-21
Plain-language 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.
Who can participate
Age range
70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Impact of frailty on grade 3-4 Chemotherapy Toxicity in Patients with Solid and Hematologic Malignancies.
Timeframe: 12 months from screening
Trial details
NCT IDNCT07624370
SponsorAzienda Socio Sanitaria Territoriale Ovest Milanese, Ospedale di Legnano