Digestive CancersPhase 3NCT00455247
Efficacy of an Oral Formula in Prevention of Anti-cancer Therapy Side Effects
A Phase 3 study testing Glutamine in people with Digestive Cancers, run by Société des Produits Nestlé (SPN) at 7 sites in France.
Trial summary
Anti-cancer treatment is often inducing side-effects that can affect the compliance to the treatment protocol and quality of life of the patients. The researchers will study if the nutritional intervention with the product could abrogate the undesired effects in a preventive manner. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Digestive Cancers
- What is being tested?
- Glutamine
- How many people
- Not given
- Where
- 7 sitesFrance
- Study dates
- Oct 2007to Jan 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with GI neoplasm
- Patient that must start a (new) line of chemotherapy with at least 2 cycles
- Age > 18 ans
- Exclusively orally fed
- Life expectancy more than 3 months
- Intravenous 5FU-based chemotherapy with 2 or 3-week cycles
- Hematological toxicities from previous chemotherapies terminated or <= 2
Who cannot join
- Positive HIV status
- Pregnant or lactating woman
- Currently participating or having participated in another clinical trial during the last month prior to the beginning of this study
- Patient having diarrhoea of grade > 1 for more than 2 weeks before the inclusion
- State of sub occlusion, chronic inflammatory diseases of the digestive tract, radiation enteropathy
- Sepsis
- Concomitant radiotherapy, except analgesic radiotherapy
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Institut Sainte-Catherine
Avignon
CH Béziers
Béziers
CRLCC Léon Bérard
Lyon, 69008
CRLC Val d'Aurelle
Montpellier, 34090
CHU Montpellier
Montpellier
CH Perpignan
Perpignan
CHU Charles Nicolle
Rouen, 76000
About this study
Anti-cancer treatment is often inducing side-effects that can affect the compliance to the treatment protocol and quality of life of the patients. The researchers will study if the nutritional intervention with the product could abrogate the undesired effects in a preventive manner.
- Conditions
- Digestive Cancers
- Being tested
- Glutamine
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlutamineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2007 (estimated)
- Study startOct 2007
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestive CancersStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pierre SENESSE, MD, Principal investigator, CRLC Val d'Aurelle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00455247
- Sponsor's protocol ID
- 06.23.CLI
- Status last verified
- Jun 2013
- First submitted
- 1 Mar 2007
- Last updated
- 5 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Oral Formula in Prevention of Anti-cancer Therapy Side Effects
- ClinicalTrials.gov ID
- NCT00455247
- Acronym / sponsor ID
- 06.23.CLI
- Conditions
- Digestive Cancers
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 3 Apr 2007 (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.
Anti-cancer treatment is often inducing side-effects that can affect the compliance to the treatment protocol and quality of life of the patients. The researchers will study if the nutritional intervention with the product could abrogate the undesired effects in a preventive manner.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient with GI neoplasm
- Patient that must start a (new) line of chemotherapy with at least 2 cycles
- Age > 18 ans
- Exclusively orally fed
- Life expectancy more than 3 months
Key exclusion criteria (7 listed)
- Positive HIV status
- Pregnant or lactating woman
- Currently participating or having participated in another clinical trial during the last month prior to the beginning of this study
- Patient having diarrhoea of grade > 1 for more than 2 weeks before the inclusion
- State of sub occlusion, chronic inflammatory diseases of the digestive tract, radiation enteropathy
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 |
|---|---|---|
| Glutamine | Drug | – |
Primary outcome
Not reported in the source record.
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 5 Jun 2013.
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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.
Pierre SENESSE, MD principal investigator
CRLC Val d'Aurelle
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Glutamine in people with Digestive Cancers, run by Société des Produits Nestlé (SPN) at 7 sites 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 7 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 5 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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.
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 5 Jun 2013; AzTrials last refreshed its copy on 8 Nov 2026.