INEC Study: Immuno-modulating Enteral Nutrition in Cancer

StatusCompleted
PhasePhase 4
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Publications: details revised at 1 of 6 entriesv13
  2. Trial status: Recruiting to Completed
    • Site details revised
    • Collaborators revised (10)
    v12
  3. Collaborators: 11 to 10v11
  4. Re-verified, no change to tracked fieldsv10
  5. Primary completion date: Sep 2010v9 Show 4 more changesShow less
    • Study 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
  3. Re-verified, no change to tracked fieldsv6
  4. Study description revised
    • Eligibility criteria expanded, about 1 word
    v5
  5. Interventions: Enteral Nutrition (Drug) to Impact (R) Enteral Nutrition (Dietary Supplement)v4 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
  6. Site contact updatedv3
  7. Eligibility criteria expanded, about 1 wordv2
  1. Study First Submitted
  • 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
(from sponsor)		 Malnutrition, Esophageal Cancer, Head and Neck Cancer
Related terms Esophageal Neoplasms, Head and Neck Neoplasms, Malnutrition
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov