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Immunonutrition to Improve Quality of Life of Upper Gastrointestinal Cancer Patients Undergoing Oncological Treatment

Phase 3
18 Years
75 Years
Open (Enrolling)
Gastrointestinal Cancer

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Trial Information

Immunonutrition to Improve Quality of Life of Upper Gastrointestinal Cancer Patients Undergoing Oncological Treatment

Inclusion Criteria:

- Histologically proven GI cancer.

- Age ≥ 18 years.

- Life expectancy more than 3 months.

- Female patients of child-bearing potential must be willing to employ effective
contraception during the study period.

- Female patients of child-bearing potential must have a negative serum Beta Human
Chorionic Gonadotrophin (βhCG) test at Visit 0.

- The patient is able to communicate effectively with study personnel and is considered
reliable, willing, and cooperative in terms of compliance with the protocol

- The patient voluntarily gives written informed consent to participate in the study.

Exclusion Criteria:

- Severe concomitant clinical conditions other than the previously untreated digestive
tract cancer that jeopardise the protocol follow-up.

- The patient is pregnant or is a lactating woman.

- Currently participating or having participated in another interventional clinical
trial related to nutritional support during the 30 days prior to the beginning of the
study product intake, except if this other interventional trial is testing new drug
or surgical intervention. (Note: participation in a prior or concurrent clinical
trial not related to nutritional support does not exclude the patient from

- Other malignancies in the last 5 years (except for successfully treated in situ
basocellular skin and in situ cervical uterine tumours).

- Patients with more than 20% weight loss over a 6 months period.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Outcome Measure:

Quality of Life (QOL), measured with the EORTC QLQ-C30

Outcome Time Frame:

QOL will me measured 30 days post-surgery

Safety Issue:


Principal Investigator

Christophe Mariette, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital Claude Huriez, CHRU-Place de Verdun-59037 Lille, Cedex France


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

July 2012

Completion Date:

June 2014

Related Keywords:

  • Gastrointestinal Cancer
  • Quality of life
  • Cancer
  • Immunonutrition
  • Gastrointestinal Neoplasms