NCT00333099

Brief 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, treatment tolerance), nutritional and immune status, and life quality parameters.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2006

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 1, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2006

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

September 14, 2012

Status Verified

September 1, 2012

Enrollment Period

4.3 years

First QC Date

June 1, 2006

Last Update Submit

September 13, 2012

Conditions

MalnutritionEsophageal CancerHead and Neck Cancer

Keywords

Enteral nutritionimmunonutrientshead and neck canceresophageal cancerchemoradiotherapyH&N or esophageal cancer patients with a chemoradiotherapy treatment.

Outcome Measures

Primary Outcomes (1)

  • Frequency and grade of mucositis

    each visit

Secondary Outcomes (5)

  • Effect on treatment conditions (interruption, doses)

    each visit

  • Other complications linked to chemoradiotherapy

    each week of chemoradiotherapy

  • Nutritional and immune status

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

  • Life quality

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

  • Cost

    each visit

Study Arms (1)

nutrition

PLACEBO COMPARATOR

study of immuno-modulating enteral nutrition

Dietary Supplement: Impact (R) Enteral NutritionOther: impact

Interventions

Impact (R) Enteral NutritionDIETARY_SUPPLEMENT

mucositis frequency, treatment tolerance

nutrition
impactOTHER

1500 calories every day : -5 days before the begining of the chemoradiotherapy and until the last day of the treatment

nutrition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hotel Dieu

Clermont-Ferrand, Auvergne, 63058, France

Location

Related Publications (6)

  • 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.

    PMID: 10430262BACKGROUND

  • 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.

    PMID: 12099649BACKGROUND

  • 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.

    PMID: 12055582BACKGROUND

  • 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.

    PMID: 15266308BACKGROUND

  • 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.

    PMID: 25575640DERIVED

  • 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.

    PMID: 23849811DERIVED

Related Links

MeSH Terms

Conditions

MalnutritionEsophageal NeoplasmsHead and Neck Neoplasms

Interventions

Enteral Nutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Feeding MethodsTherapeuticsNutritional SupportNutrition Therapy

Study Officials

  • Corinne Bouteloup, Doctor

    Hotel Dieu Service d'Hepato-Gastro-Enterologie (service du Pr G. Bommelaer) Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

  • Marie-Paule Vasson, Professor

    CLAN, Unité de Nutrition, Centre Jean Perrin (Clermont-Ferrand)

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2006

First Posted

June 2, 2006

Study Start

May 1, 2006

Primary Completion

September 1, 2010

Study Completion

September 1, 2011

Last Updated

September 14, 2012

Record last verified: 2012-09

Locations

FR(1)