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Can a special diet before surgery prevent infections in head and neck cancer patients?

NCT ID NCT00765440

Disease control Sponsor: Centre Antoine Lacassagne 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tested whether giving a special nutritional supplement (immunonutrition) before and after surgery could reduce infections in 311 patients with head and neck cancer. Participants were randomly assigned to one of three nutrition regimens. The main goal was to see if the supplement lowered the rate of infectious complications after surgery.

What this could mean

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

Active substance
therapeutic nutritional supplementation (immunonutrition)
What this could lead to
If it works, this could show that a specific nutritional supplement given around surgery lowers the risk of infections in head and neck cancer patients.
What could go wrong
This trial is completed but results are not yet widely confirmed. The benefit may be small or not apply to all patients. Nutritional supplements are generally safe, but the effect on infection rates is uncertain.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

311 people

The number who actually took part.

Start date

Jul 2007

Finished

Apr 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 to 75 years

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.

DISEASE CHARACTERISTICS: * Diagnosis of de novo cancer of the upper aerodigestive tract, including the following: * Oral cavity * Larynx * Oropharynx * Hypopharynx * Planned surgical excision of tumors with opening of the mucous membranes, with or without immediate reconstruction by myocutaneous pedicle flap or free-bone graft * Planned adjuvant enteral nutritional regimen lasting at least 7 days post-operatively PATIENT CHARACTERISTICS: * ANC \> 1.8 x 10\^9/L * Hemoglobin \> 9 g/dL * Transaminases ≤ 3 times upper limit of normal (ULN) * Bilirubin ≤ 3 times ULN * Creatinine 70-250 μmol/L * Urea ≤ 1.5 times ULN * Glucose \< 1.5 g/L * Sodium \< 145 mmol/L * Not pregnant or nursing * Fertile patients must use effective contraception * No psychological, social, geographical, or familial reasons prohibiting follow-up * No insulin-dependent diabetes * No severe psychiatric illness PRIOR CONCURRENT THERAPY: * No head and neck surgery for cancer within the past year * No prior oral components of immunonutrition * No prior neoadjuvant chemotherapy * No prior radiotherapy to head and neck

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Conditions

The condition(s) this trial relates to.

head and neck cancer Head and Neck Neoplasms Infections infectious disease Malnutrition nutritional deficiency disease Squamous Cell Carcinoma of Head and Neck tongue cancer upper aerodigestive tract neoplasm

As listed by the trial registrant

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

Head and neck cancer Infection Malnutrition

Contacts and locations

Locations

  • Centre Antoine Lacassagne

    Nice, 06189, France

More trials for these conditions

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