Malnutrition, Esophageal Cancer, Head and Neck Cancer
Conditions
Keywords
Enteral nutrition, immunonutrients, head and neck cancer, esophageal cancer, chemoradiotherapy, H&N or esophageal cancer patients with a chemoradiotherapy treatment.
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.
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.
Interventions
DIETARY_SUPPLEMENTImpact (R) Enteral Nutrition
mucositis frequency, treatment tolerance
OTHERimpact
1500 calories every day : -5 days before the begining of the chemoradiotherapy and until the last day of the treatment
Sponsors
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
University Hospital, Clermont-Ferrand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency and grade of mucositis | each visit |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
France
Outcome results
None listed