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New study tracks gut health and confusion in malnourished cancer surgery patients

NCT ID NCT07622888

Knowledge-focused Sponsor: Arma Ltd. 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 follows 120 malnourished adults undergoing major abdominal or pelvic cancer surgery to see how their gut function, nutrition, and risk of confusion (delirium) change in the first week after surgery. Researchers will also check if giving a natural chemical called serotonin through a vein helps the gut recover faster. No treatments are assigned—doctors provide standard care, and the study simply records what happens.

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 120 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

Adult patients (≥18 years) with histologically or cytologically confirmed abdominal or pelvic malignancy scheduled for major oncologic surgery (radical or cytoreductive), with pre existing malnutrition (NRS 2002 ≥3 and ≥1 phenotypic + ≥1 etiologic GLIM criterion), and expected postoperative hospital stay ≥7 days.

Ages

18 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 ≥ 18 years. * Histologically confirmed malignant tumor of the abdomen or pelvis with planned radical or cytoreductive surgery. * Baseline malnutrition defined as NRS2002 ≥ 3 and at least one phenotypic and one etiologic GLIM criterion. * Expected postoperative hospitalization ≥ 7 days. * Ability to undergo baseline cognitive and nutritional assessments (MoCA, NRS2002, GLIM, PG-SGA) prior to surgery. * Signed informed consent for participation and data collection. Exclusion Criteria: * Severe decompensated hepatic or renal failure rendering surgery infeasible. * Documented preexisting severe cognitive impairment or dementia precluding valid postoperative cognitive/delirium assessment (e.g., MoCA \< 18 or documented dementia). * Pregnancy or breastfeeding. * Participation in another interventional randomized clinical trial within the prior 30 days that could confound outcomes. * Inability to ensure postoperative follow-up or reliable data collection (planned transfer without access, loss of contact).

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Conditions

The condition(s) this trial relates to.

Abdominal Neoplasms delirium Emergence Delirium Malnutrition neoplasm nutritional deficiency disease Pelvic Neoplasms

As listed by the trial registrant

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

Abdominal neoplasm Delirium, postoperative Gastrointestinal dysfunction Malnutrition Pelvic neoplasm

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

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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

  • North-Western District Scientific and Clinical Center named after L.G. Sokolov, FMBA of Russia

    Saint Petersburg, 194291, Russia

More trials for these conditions

Other studies related to the condition(s) this trial covers.