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MalnutritionPhase 4NCT00333099

INEC Study: Immuno-modulating Enteral Nutrition in Cancer

A Phase 4 study testing Impact (R) Enteral Nutrition and impact in people with Malnutrition and Esophageal Cancer, run by University Hospital, Clermont-Ferrand at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study is to investigate if enteral immunonutrition of head and neck or esophageal cancer patients, using an arginine, omega 3 fatty acid, nucleotides-enhanced diet [Impact (R), Novartis] versus a standard enteral nutrition (control, Novartis), could improve clinical outcomes (mucositis frequency… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Impact (R) Enteral Nutrition and impact
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
250 participants
Where
1 siteFrance
Study dates
May 2006to Sep 2011
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hotel Dieu

    Clermont-Ferrand, Auvergne, 63058

Other trials in France

About this study

Official title: Effect of Enteral Immunonutrition During Chemoradiotherapy in Patients With Head and Neck Cancer or Esophageal Cancer

The aim of this study is to investigate if enteral immunonutrition of head and neck or esophageal cancer patients, using an arginine, omega 3 fatty acid, nucleotides-enhanced diet [Impact (R), Novartis] versus a standard enteral nutrition (control, Novartis), could improve clinical outcomes (mucositis frequency, treatment tolerance), nutritional and immune status, and life quality parameters.

Read the detailed description

Malnutrition is frequent in head and neck (H\&N) and esophageal cancers and alters immune status, anti-infectious and anti-tumoral defenses and the response to the treatment (surgery, chemotherapy, radiotherapy). Treatment of these 2 types of cancer is often chemoradiotherapy which frequently induces mucositis. Mucositis enhances nutritional risk and could impose a modification or an interruption of the treatment. The aim of this study is to investigate if enteral immunonutrition of head and neck or esophageal cancer patients, using an arginine, omega 3 fatty acid, nucleotides-enhanced diet [Impact(R), Novartis] versus a standard enteral nutrition (control, Novartis), could improve clinical outcomes (mucositis frequency, treatment tolerance), nutritional and immune status, and life quality parameters.

Being tested
Impact (R) Enteral Nutrition, impact
Keywords
Enteral nutrition, immunonutrients, head and neck cancer, esophageal cancer, chemoradiotherapy, H&N or esophageal cancer patients with a chemoradiotherapy treatment.
Medical subject headings
Malnutrition, Esophageal Neoplasms, Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Impact (R) Enteral NutritionDietary supplement

    mucositis frequency, treatment tolerance

  • impactOther

    1500 calories every day :

    -5 days before the begining of the chemoradiotherapy and until the last day of the treatment

Study groups in NCT00333099
Study groupRoleWhat they receive
nutritionPlacebo comparatorstudy of immuno-modulating enteral nutrition
Receives: Dietary Supplement: Impact (R) Enteral Nutrition; Other: impact

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency and grade of mucositis

    Measured: each visit

Secondary outcomes (5)

  1. Effect on treatment conditions (interruption, doses)

    Measured: each visit

  2. Other complications linked to chemoradiotherapy

    Measured: each week of chemoradiotherapy

  3. Nutritional and immune status

    Measured: at randomisation's visit, visit at the end of treatment, 1, 6 and 12 months after the end of treatment

  4. Life quality

    Measured: at randomisation's visit, visit at the end of treatment, 6 and 12 months after the end of treatment

  5. Cost

    Measured: each visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2006 (estimated)
  2. Study startMay 2006
  3. Primary completionSep 2010
  4. Study completionSep 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00333099
Sponsor's protocol ID
CHU63-0012
Status last verified
Jul 2026
First submitted
1 Jun 2006
Last updated
3 Aug 2026
Results posted
No

Publications

  • Vasson MP, Talvas J, Perche O, Dillies AF, Bachmann P, Pezet D, Achim AC, Pommier P, Racadot S, Weber A, Ramdani M, Kwiatkowski F, Bouteloup C. Immunonutrition improves functional capacities in head and neck and esophageal cancer patients undergoing radiochemotherapy: a randomized clinical trial. Clin Nutr. 2014 Apr;33(2):204-10. doi: 10.1016/j.clnu.2013.06.008. Epub 2013 Jun 20.

    PubMed 23849811

  • van Bokhorst-de van der Schuer, van Leeuwen PA, Kuik DJ, Klop WM, Sauerwein HP, Snow GB, Quak JJ. The impact of nutritional status on the prognoses of patients with advanced head and neck cancer. Cancer. 1999 Aug 1;86(3):519-27.

    PubMed 10430262

  • Nozoe T, Kimura Y, Ishida M, Saeki H, Korenaga D, Sugimachi K. Correlation of pre-operative nutritional condition with post-operative complications in surgical treatment for oesophageal carcinoma. Eur J Surg Oncol. 2002 Jun;28(4):396-400. doi: 10.1053/ejso.2002.1257.

    PubMed 12099649

  • Gianotti L, Braga M, Nespoli L, Radaelli G, Beneduce A, Di Carlo V. A randomized controlled trial of preoperative oral supplementation with a specialized diet in patients with gastrointestinal cancer. Gastroenterology. 2002 Jun;122(7):1763-70. doi: 10.1053/gast.2002.33587.

    PubMed 12055582

  • de Luis DA, Arranz M, Aller R, Izaola O, Cuellar L, Terroba MC. Immunoenhanced enteral nutrition, effect on inflammatory markers in head and neck cancer patients. Eur J Clin Nutr. 2005 Jan;59(1):145-7. doi: 10.1038/sj.ejcn.1602034.

    PubMed 15266308

  • Talvas J, Garrait G, Goncalves-Mendes N, Rouanet J, Vergnaud-Gauduchon J, Kwiatkowski F, Bachmann P, Bouteloup C, Bienvenu J, Vasson MP. Immunonutrition stimulates immune functions and antioxidant defense capacities of leukocytes in radiochemotherapy-treated head & neck and esophageal cancer patients: A double-blind randomized clinical trial. Clin Nutr. 2015 Oct;34(5):810-7. doi: 10.1016/j.clnu.2014.12.002. Epub 2014 Dec 9.

    PubMed 25575640

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Impact (R) Enteral Nutrition and impact in people with Malnutrition and Esophageal Cancer, run by University Hospital, Clermont-Ferrand at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency and grade of mucositis (time frame: each visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00333099, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.

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