Immunonutrition and Quality of Life of Cancer Patients Undergoing Oncological Treatment
NCT ID: NCT01423799
Last Updated: 2015-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
300 participants
INTERVENTIONAL
2012-07-31
2015-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Nutritional product
Nutritional intervention containing immuno-nutrients
Nutritional supplements containing arginine, n-3 and nucleotides
Nutritional intervention with immuno-nutrients
Control Group
Isocaloric and isonitrogenous control without immuno nutrients.
Isocaloric control
Isocaloric and isonitrogenous control without immuno nutrients
Interventions
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Nutritional supplements containing arginine, n-3 and nucleotides
Nutritional intervention with immuno-nutrients
Isocaloric control
Isocaloric and isonitrogenous control without immuno nutrients
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Société des Produits Nestlé (SPN)
INDUSTRY
Responsible Party
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Principal Investigators
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Christophe Mariette, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Claude Huriez, CHRU-Place de Verdun-59037 Lille, Cedex France
Locations
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Centre Hospitalier Régional Universitaire de Lille
Lille, , France
Countries
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Other Identifiers
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09.54.CLI
Identifier Type: -
Identifier Source: org_study_id
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