Gastrointestinal CancerPhase 3NeoimmuneNCT01423799
Immunonutrition and Quality of Life of Cancer Patients Undergoing Oncological Treatment
A Phase 3 study testing Nutritional supplements containing arginine, n-3 and nucleotides in people with Gastrointestinal Cancer, run by Société des Produits Nestlé (SPN) at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastrointestinal Cancer
- What is being tested?
- Nutritional supplements containing arginine, n-3 and nucleotides
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2012to Oct 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunonutrition to Improve Quality of Life of Upper Gastrointestinal 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.
- Conditions
- Gastrointestinal Cancer
- Being tested
- Nutritional supplements containing arginine, n-3 and nucleotides, Isocaloric control
- Keywords
- Quality of life, Cancer, Immunonutrition
- Medical subject headings
- Gastrointestinal Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional supplements containing arginine, n-3 and nucleotidesDietary supplement
Nutritional intervention with immuno-nutrients
Isocaloric controlDietary supplement
Isocaloric and isonitrogenous control without immuno nutrients
| Study group | Role | What they receive |
|---|---|---|
| Nutritional product | Experimental | Nutritional intervention containing immuno-nutrients Receives: Dietary Supplement: Nutritional supplements containing arginine, n-3 and nucleotides |
| Control Group | Active comparator | Isocaloric and isonitrogenous control without immuno nutrients. Receives: Dietary Supplement: Isocaloric control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life (QOL), measured with the EORTC QLQ-C30
Measured: QOL will me measured 30 days post-surgery
Secondary outcomes (1)
QOL assessed by the EORTC QLQ-OG 25
Measured: QOL will me measured 30 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2011 (estimated)
- Study startJul 2012
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal CancerStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christophe Mariette, MD, Principal investigator, University Hospital Claude Huriez, CHRU-Place de Verdun-59037 Lille, Cedex France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01423799
- Sponsor's protocol ID
- 09.54.CLI
- Acronym
- Neoimmune
- Status last verified
- Nov 2015
- First submitted
- 24 Aug 2011
- Last updated
- 13 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunonutrition to Improve Quality of Life of Upper Gastrointestinal Cancer Patients Undergoing Oncological Treatment
- ClinicalTrials.gov ID
- NCT01423799
- Acronym / sponsor ID
- Neoimmune / 09.54.CLI
- Conditions
- Gastrointestinal Cancer
- Keywords
- Quality of life, Cancer, Immunonutrition
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 26 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutritional product | Experimental | Dietary Supplement: Nutritional supplements containing arginine, n-3 and nucleotidesNutritional intervention containing immuno-nutrients |
| Control Group | Active comparator | Dietary Supplement: Isocaloric controlIsocaloric and isonitrogenous control without immuno nutrients. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional supplements containing arginine, n-3 and nucleotidesNutritional intervention with immuno-nutrients | Dietary supplement | Nutritional product |
| Isocaloric controlIsocaloric and isonitrogenous control without immuno nutrients | Dietary supplement | Control Group |
Primary outcome
Quality of Life (QOL), measured with the EORTC QLQ-C30
Time frame: QOL will me measured 30 days post-surgery
1 secondary outcome
QOL assessed by the EORTC QLQ-OG 25
Time frame: QOL will me measured 30 days post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2015.
Related trials for Gastrointestinal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christophe Mariette, MD principal investigator
University Hospital Claude Huriez, CHRU-Place de Verdun-59037 Lille, Cedex France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nutritional supplements containing arginine, n-3 and nucleotides in people with Gastrointestinal Cancer, run by Société des Produits Nestlé (SPN) at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (QOL), measured with the EORTC QLQ-C30 (time frame: QOL will me measured 30 days post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2015.