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Could a Nutrient-Rich diet tame the painful side effects of chemoradiotherapy?

NCT ID NCT00333099

Symptom relief Sponsor: University Hospital, Clermont-Ferrand 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time

Summary

This trial tests whether a special liquid nutrition formula, enriched with arginine, omega-3 fatty acids, and nucleotides, can reduce the frequency and severity of mouth sores (mucositis) in patients with head and neck or esophageal cancer undergoing chemoradiotherapy. Participants receive either this immunonutrition or a standard nutrition formula through a feeding tube, starting before treatment and continuing until the last day. The study also looks at treatment tolerance, nutritional and immune status, quality of life, and costs.

What this could mean

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

Active substance
An enteral nutrition formula enriched with arginine, omega-3 fatty acids, and nucleotides (Impact), compared with a standard enteral nutrition formula.
What this could lead to
If effective, this special nutrition could reduce painful mouth sores and help patients complete their cancer treatment with fewer interruptions, improving quality of life.
What could go wrong
This is a phase 4 trial, but results may still be uncertain. The special formula might not reduce mucositis more than standard nutrition, and some patients may experience digestive discomfort or other side effects.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

250 people

The number who actually took part.

Start date

May 2006

Finished

Sep 2011

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: * H\&N and esophageal cancer patients, not treated by surgery and needing chemoradiotherapy * Performance status: Objective Mucositis Score (OMS) of 0, 1, 2 or Karnofsky \> 50% * Acceptance of a gastrostomy, jejunostomy or a nasogastric tube to conduct enteral nutrition * Informed consent form signed Exclusion Criteria: * H\&N cancer treated by exclusive radiotherapy * H\&N and esophageal cancer which can be treated by exclusive surgery * Tonsil cancer * Existence of metastases * Concomitant cancer * Repeat of cancer at site * Insulin dependant diabetes * Thyroid diseases * Subjects with major surgery or severe infectious status in the 3 preceding months * Biological assessment incompatible with the esophagus chemotherapy treatment (polynuclear cells \< 1500/ml; blood platelets \< 100000/ml; serum creatinine \> 130 µmol/ml; ASAT, ALAT, ALP and bilirubin \> twice the norm) * Patients taking food or supplements enriched with omega 3 (arginine and nucleotides), during the period of the study and in the preceding month * Breast feeding women or in period of fertility without effective means of contraception * Patients who refuse to participate or are unable to receive information or are unable to sign written informed consent.

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Conditions

The condition(s) this trial relates to.

esophageal cancer Esophageal Neoplasms head and neck cancer Head and Neck Neoplasms Malnutrition nutritional deficiency disease

As listed by the trial registrant

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

Esophageal cancer Head and neck cancer Malnutrition

Contacts and locations

Locations

  • Hotel Dieu

    Clermont-Ferrand, Auvergne, 63058, France

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