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Frailty check could predict chemo danger for seniors

NCT ID NCT07624370

Knowledge-focused Sponsor: Azienda Socio Sanitaria Territoriale Ovest Milanese, Ospedale di Legnano Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how frailty—a state of weakness and reduced physical function—affects the risk of severe side effects from chemotherapy in people aged 70 and older with cancer. Researchers will assess 160 patients using various tests for frailty, muscle loss, and overall health before treatment. The goal is to see if frailty can predict who will experience serious toxicity, helping doctors tailor treatments more safely.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help doctors identify which older patients are at higher risk of severe side effects from chemotherapy, leading to more personalized and safer treatment plans.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly improve outcomes. Results may not apply to all cancer types or treatment settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 160 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

70 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

biliary tract cancer colorectal cancer esophageal cancer Frailty gastric cancer hematologic disorder intestinal cancer lung cancer lymphoma malignant pancreatic neoplasm mesothelioma plasma cell myeloma Sarcopenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Frailty/sarcopenia Hematologic disease Oncological patients Sarcopenia in elderly

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Trial Office-ASST Ovest Milanese

    Legnano, Italy, 20025, Italy

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