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OpenTrials
Completed

NCT Number: NCT01423799

Immunonutrition and Quality of Life of Cancer Patients Undergoing Oncological Treatment

The purpose of this study is to compare the health-related quality of life following dietary supplementation with an immunonutrition formulation vs an isocaloric/isoprotein control diet supplement in patients suffering from upper digestive tract neoplasia undergoing oncological treatment.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centre Hospitalier Régional Universitaire de Lille

Lille, 59037, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 requirements.
  • 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 participation.)
  • 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.

Treatment and study plan

Nutritional supplements containing arginine, n-3 and nucleotides

Dietary Supplement

Nutritional intervention with immuno-nutrients

Isocaloric control

Dietary Supplement

Isocaloric and isonitrogenous control without immuno nutrients

Primary outcomes

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

    Time frame: QOL will me measured 30 days post-surgery

Secondary outcomes

  1. QOL assessed by the EORTC QLQ-OG 25

    Time frame: QOL will me measured 30 days post-surgery

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

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

Acronym: Neoimmune

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Aug 26, 2011
Registry last updated
Nov 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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