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INEC Study: Immuno-modulating Enteral Nutrition in Cancer

StatusCompleted
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Publications: details revised at 1 of 6 entriesv13
  2. Trial status: Recruiting to Completed Site details revised · Collaborators revised (10)v12 Show 2 more changesShow less
    • Site details revised
    • Collaborators revised (10)

    See this version in full on ClinicalTrials.gov ↗

  3. Collaborators: 11 to 10v11 See this version in full on ClinicalTrials.gov ↗
  4. Re-verified, no change to tracked fieldsv10
  5. Primary completion date: Sep 2010 Completion date: Apr 2009 to Sep 2011 · Interventions: Impact (R) Enteral Nutrition (Dietary Supplement) to Impact (R) Enteral Nutrition (Dietary Supplement), impact (Other) · Secondary endpoints: details revised at 5 of 5 entries · 1 morev9 Show 4 more changesShow less
    • Completion date: Apr 2009 to Sep 2011
    • Interventions: Impact (R) Enteral Nutrition (Dietary Supplement) to Impact (R) Enteral Nutrition (Dietary Supplement), impact (Other)
    • Secondary endpoints: details revised at 5 of 5 entries
    • Study arms: 0 to 1
Show 7 earlier versionsHide 7 earlier versions
  1. Study Identification, Study Statusv8
  2. Collaborators revised (11)v7 See this version in full on ClinicalTrials.gov ↗
  3. Re-verified, no change to tracked fieldsv6
  4. Study description revised Eligibility criteria expanded, about 1 wordv5 Show 1 more changeShow less
    • Eligibility criteria expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  5. Interventions: Enteral Nutrition (Drug) to Impact (R) Enteral Nutrition (Dietary Supplement) Eligibility criteria expanded, about 11 words · Secondary endpoints revised (5) · Study description shortened, about 1 word · 1 morev4 Show 4 more changesShow less
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints revised (5)
    • Study description shortened, about 1 word
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  6. Site contact updatedv3
  7. Eligibility criteria expanded, about 1 wordv2 See this version in full on ClinicalTrials.gov ↗
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00333099
Lead Sponsor University Hospital, Clermont-Ferrand
Collaborators: Fonds National d'Aménagement et de Développement du territoire (FNADT), European Regional Development Fund, Centre Jean Perrin, Centre Leon Berard, Institut de Cancérologie de la Loire, Centre Hospitalier Universitaire de Saint Etienne, Hôpital Edouard Herriot, University Hospital, Grenoble, Orkyn', Novartis
Conditions Malnutrition, Esophageal Cancer, Head and Neck Cancer
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov