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Simple frailty quiz may predict chemo risks in seniors

NCT ID NCT07272538

Knowledge-focused Sponsor: Ankara Etlik City Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at whether two easy-to-use frailty checklists (FRAIL and FiND) can predict severe side effects from chemotherapy in adults aged 65 and older with gastrointestinal cancers. Researchers followed 84 patients who had already had surgery and were receiving standard chemo. They found that higher frailty scores at the start of treatment were linked to more serious side effects, which could help doctors personalize care for older patients.

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

84 people

The number who actually took part.

Started

Dec 2023

Finished

Dec 2024

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Who is studied

This study included older adults (≥65 years) with gastrointestinal cancers who underwent curative-intent surgery and received standard adjuvant chemotherapy at Ankara Etlik City Hospital. A total of 84 participants were evaluated. All participants completed baseline frailty assessments (FRAIL and FiND) before chemotherapy initiation and were followed throughout the full adjuvant treatment course.

Ages

65 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: * Age ≥65 years * Histologically confirmed gastrointestinal (GI) malignancy, including: Colorectal adenocarcinoma (colon or rectum), Gastric adenocarcinoma, Pancreatic adenocarcinoma, Biliary tract cancer (cholangiocarcinoma, gallbladder cancer) Small intestine adenocarcinoma, Esophageal cancer (adenocarcinoma or squamous cell carcinoma) * Completion of curative-intent surgery with a postoperative plan for adjuvant chemotherapy. * Receipt of standard adjuvant chemotherapy, including (but not limited to): FOLFOX, CAPOX (XELOX), Capecitabine monotherapy, FOLFIRINOX (selected fit older adults only), Gemcitabine ± capecitabine * Initiation of adjuvant chemotherapy within the study period. * Baseline frailty assessment (FRAIL Scale and FiND questionnaire) completed before the first chemotherapy cycle. * Ability to provide informed consent and comply with frailty and toxicity follow-up assessments. Exclusion Criteria: * Age \<65 years. * Metastatic, recurrent, or unresectable disease at the time of adjuvant treatment. * Receiving neoadjuvant-only treatment without subsequent adjuvant chemotherapy. * Non-adenocarcinoma GI malignancies treated with protocols outside standard adjuvant chemotherapy (e.g., GIST receiving adjuvant imatinib; neuroendocrine tumors). * Prior chemotherapy within 12 months for another malignancy. * Missing baseline frailty assessment (FRAIL or FiND). * Missing toxicity follow-up after chemotherapy initiation. * Severe cognitive impairment, advanced dementia, or psychiatric illness preventing reliable questionnaire completion. * Concurrent participation in another interventional clinical trial that may alter chemotherapy toxicity or functional outcomes.

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Conditions

The condition(s) this trial relates to.

biliary tract cancer colorectal adenocarcinoma digestive system cancer digestive system neoplasm esophageal cancer Frailty gastric adenocarcinoma pancreatic adenocarcinoma small intestine adenocarcinoma

As listed by the trial registrant

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

Chemotherapy Frailty at older adults Gastrointestinal cancers

Contacts and locations

Locations

  • Etlik City Hospital Medical Oncology Department

    Ankara, Yenimahalle, 06270, Turkey (Türkiye)

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