Immunonutrition and Quality of Life of Cancer Patients Undergoing Oncological Treatment (Neoimmune)
This study is currently recruiting participants.
Verified March 2013 by Nestlé
Sponsor:
Nestlé
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01423799
First received: August 24, 2011
Last updated: March 27, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastrointestinal Cancer |
Dietary Supplement: Nutritional supplements containing arginine, n-3 and nucleotides Dietary Supplement: Isocaloric control |
Phase 3 |
| Study Type: | Interventional |
| 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 |
| Official Title: | Immunonutrition to Improve Quality of Life of Upper Gastrointestinal Cancer Patients Undergoing Oncological Treatment |
Resource links provided by NLM:
Further study details as provided by Nestlé:
Primary Outcome Measures:
- Quality of Life (QOL), measured with the EORTC QLQ-C30 [ Time Frame: QOL will me measured 30 days post-surgery ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- QOL assessed by the EORTC QLQ-OG 25 [ Time Frame: QOL will me measured 30 days post-surgery ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 358 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Nutritional product
Nutritional intervention containing immuno-nutrients
|
Dietary Supplement: Nutritional supplements containing arginine, n-3 and nucleotides
Nutritional intervention with immuno-nutrients
|
|
Active Comparator: Control Group
Isocaloric and isonitrogenous control without immuno nutrients.
|
Dietary Supplement: Isocaloric control
Isocaloric and isonitrogenous control without immuno nutrients
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01423799
Contacts
| Contact: Eduardo J Schiffrin | + 41 21 785 9515 | eduardo.schiffrin@rdls.nestle.com |
Locations
| France | |
| Centre Hospitalier Régional Universitaire de Lille | Recruiting |
| Lille, France, 59037 | |
| Contact: Christophe Mariette, Professor christophe.mariette@chru-lille.fr | |
| Principal Investigator: Christophe Mariette, Professor | |
Sponsors and Collaborators
Nestlé
Investigators
| Principal Investigator: | Christophe Mariette, MD | University Hospital Claude Huriez, CHRU-Place de Verdun-59037 Lille, Cedex France |
More Information
No publications provided
| Responsible Party: | Nestlé |
| ClinicalTrials.gov Identifier: | NCT01423799 History of Changes |
| Other Study ID Numbers: | 09.54.CLI |
| Study First Received: | August 24, 2011 |
| Last Updated: | March 27, 2013 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Nestlé:
|
Quality of life Cancer Immunonutrition |
Additional relevant MeSH terms:
|
Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases |
ClinicalTrials.gov processed this record on June 18, 2013