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New study tests nutritional supplement to tame chemo side effects

NCT ID NCT07590622

Symptom relief Sponsor: IRCCS San Raffaele 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a special nutritional supplement (LH BLU) can reduce serious side effects in people with advanced gastrointestinal cancers who are starting chemotherapy. About 88 participants will either receive the supplement plus nutritional counseling or just counseling alone. The main goal is to see if the supplement lowers the chance of severe side effects.

What this could mean

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

Active substance
LH BLU (a special nutritional supplement with extra nutrients like glutamine, vitamin D, zinc, and selenium)
What this could lead to
If it works, this could point toward a way to reduce severe side effects from chemotherapy in advanced gastrointestinal cancer patients.
What could go wrong
This is a small, early-stage trial with only 88 participants, so results may not apply to everyone. The supplement may not reduce side effects more than standard nutritional counseling.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 88 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jun 2031

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.

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: 1. Will to participate by providing written IC. 2. Male or female aged 18 years or older. 3. A confirmed histological or radiological (in case of hepatocellular carcinoma) diagnosis of advanced GI cancer. 4. Undergoing first-line systemic treatment for advanced disease as determined by the investigators, following good clinical practice and guidelines. 5. Availability to take ONS. 6. Patient's willingness to undergo blood draws to provide plasma and blood samples for analysis according to study objectives. 7. An ECOG PS of 2 or less. 8. Investigator's assessment of life expectancy ≥ 3 months. Exclusion Criteria: 1. Are under 18 years of age. 2. Inability to sign an IC. 3. Inability to follow the procedures of the study, e.g. due to language barrier, major psychological disorders, dementia, etc.; 4. Indication to ongoing artificial nutrition support (totally compromised spontaneous food-intake) and incapacity or unavailability to consume ONS; 5. Pregnancy or lactation.

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Conditions

The condition(s) this trial relates to.

digestive system cancer digestive system neoplasm

As listed by the trial registrant

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

Gastrointestinal cancer

How to take part

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

  1. 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 ↗

  2. 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.

More trials for these conditions

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