Myeloablative Allo-SCTPhase 3NEPHANCT01955772
Randomized, Prospective, Multicenter Study to Compare Enteral Nutrition to Parenteral Nutrition as Feeding Support in Patients Presenting Malignant Hemopathy Who Underwent an Allogeneic Hematopoietic Stem Cell Transplantation.
A Phase 3 study testing Enteral nutrition alanyl-glutamin, Dipeptiven in people with Myeloablative Allo-SCT, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Myeloablative allogeneic hematopoetic stem cell transplantation (AHSCT) are prone to frequent secondary malnutrition to metabolic and digestive troubles due to conditioning regimen, treatments (antibiotics, immunosuppressive therapy…) and graft complications (graft versus host disease). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Myeloablative Allo-SCT
- What is being tested?
- Enteral nutrition alanyl-glutamin, Dipeptiven
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2013to Jul 2017
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 65 years
- Men and women
- Patients undergoing myeloablative allo-SCT
- Allo-SCT genoidentical or phenoidentical 10/10
- Patients affiliated with a social security organisation
- Patients having signed the informed consent
Who cannot join
- Status of tumour progression at the moment of the allo-SCT
- Artificial nutrition begun before the inclusion
- Inability to understand the protocol (linguistic barrier, cognitive difficulties)
- Contraindication or associated pathology that does not allow to carry out EN or PN according to the protocol
- Medical history of progressive psychiatric illness
- Medical history of another progressive cancer or occurrence in the 5 previous years
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- Presence of a simultaneous serious and uncontrolled disease such as severe cardiac, renal, hepatic or respiratory failure or severe sepsis
- Previous allo-SCT
- Participation in another clinical trial studying an allograft procedure, and applying modalities that are not available in routine practice (including innovative immunosuppression and graft or conditioning regimens not considered as myeloablative)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
About this study
Myeloablative allogeneic hematopoetic stem cell transplantation (AHSCT) are prone to frequent secondary malnutrition to metabolic and digestive troubles due to conditioning regimen, treatments (antibiotics, immunosuppressive therapy…) and graft complications (graft versus host disease). In the absence of appropriate nutritional support, myeloablative conditioning lead to a rapid serious denutrition. But, it is known as negative independent prognostic factor of overall survival of patients who presented malignant hemopathy treated by high-dose chemotherapy or AHSCT. Furthermore, it increases hospitalisation delay and decreases quality of life. In AHSCT with myeloablative conditioning, introduction of nutritional support is recommended. However, type of nutritional support remains not clearly defined. Parenteral nutrition is user but favour infections and secondary effects potentially decrease by intravenous glutamine. Few previous studies with low number of patients, mainly retrospective or combining allo-and auto HSCT had shown feasibility, acceptable tolerance and low cost of enteral nutrition (EN). A recent prospective no-randomized study in 45 adults patients who had undergone AHSCT with myeloablative conditioning find a significant decrease of day-100 mortality (5% vs 30%), of infection mortality, of median duration of parenteral nutrition (PN) and prevalence of GvH (Graft versus Host Disease) grade III-IV in EN (enteral nutrition) group. These results had to be confirmed by a randomized study. As EN is 4 to 5 more cheaply than PN, besides mortality/morbidity stakes for the patient, this study could have potential economic interest.
Read the detailed description
EN (enteral nutrition) or PN (parenteral nutrition) artificial nutrition will be launched at D1-D2 of the transplantation (D0 being the day of the transplantation),without taking into account the oral intake. This helps in particular to launch the EN after the stage of significant digestive problems related to the conditioning and before the mucositis appearance.
EN group: According to the HAS and SFNEP (Societe francophone nutrition clinique) recommendations and the good practice rules, a polyurethane or silicone NGT(Naso gastric tube), 8 to 10 French units, will be inserted and its positioning will be controlled by radiography before the EN beginning. Polyurethane and silicone are very well tolerated by nasal and oesophagus mucosa and have a long life duration allowing keeping the same tube during 2 to 3 months.
PN group: PN will be administrated by a central venous catheter, which is usually inserted in allo-HSCT patients to allow the administration of chemotherapy and of the different parenteral treatments.
- Conditions
- Myeloablative Allo-SCT
- Being tested
- Enteral nutrition alanyl-glutamin, Dipeptiven
- Keywords
- Haematopoietic stem cell transplantation, Malignant hemopathy, Artificial nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enteral nutrition alanyl-glutamin, DipeptivenDrug
Also called All patients will received, whatever treatment arm, intravenous alanyl-glutamin, Dipeptiven which have AMM.
Enteral nutrition versus parenteral nutrition
| Study group | Role | What they receive |
|---|---|---|
| EN (Enteral Nutrition) | Experimental | NE group: According to the HAS and SFNEP recommendations and the good practice rules, a polyurethane or silicone NGT, 8 to 10 French units, will be inserted and its positioning will be controlled by radiography before the EN beginning. Polyurethane and silicone are very well tolerated by nasal and oesophagus mucosa and have a long life duration allowing keeping the same tube during 2 to 3 months.
PN group: PN will be administrated by a central venous catheter, which is usually inserted in allo-HSCT patients to allow the administration of chemotherapy and of the different parenteral treatments. Receives: Drug: Enteral nutrition alanyl-glutamin, Dipeptiven |
| PN (Parenteral Nutrition) | Other | NE group: According to the HAS and SFNEP recommendations and the good practice rules, a polyurethane or silicone NGT, 8 to 10 French units, will be inserted and its positioning will be controlled by radiography before the EN beginning. Polyurethane and silicone are very well tolerated by nasal and oesophagus mucosa and have a long life duration allowing keeping the same tube during 2 to 3 months.
PN group: PN will be administrated by a central venous catheter, which is usually inserted in allo-HSCT patients to allow the administration of chemotherapy and of the different parenteral treatments. Receives: Drug: Enteral nutrition alanyl-glutamin, Dipeptiven |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality related to the transplant
Measured: at day 100
Secondary outcomes (6)
Occurrence of post-transplant complications targeting acute GVH, mucite and infections
Measured: 12 months after AHSCT (hematopoietic stem cell transplantation)
Overall survival and disease free survival
Measured: 12 months after AHSCT (hematopoietic stem cell transplantation)
Evolution of nutritional state
All patients will received, whatever treatment arm, intravenous alanyl-glutamin, Dipeptiven which have AMM.
Measured: 12 months after AHSCT
Tolerance of nutritional support mainly on digestive and hepatobiliary disorders
All patients will received, whatever treatment arm, intravenous alanyl-glutamin, Dipeptiven which have AMM.
Measured: 12 months after AHSCT
Engraftment rates
Measured: Day30, Day60, Day90 and Day180
quality of life assessment
Measured: Day7, Day90, Day180 and Day360
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startNov 2013
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myeloablative Allo-SCTStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Societe Francaise de Greffe de Moelle et de Therapie Cellulaire, Société Francophone Nutrition Clinique et Métabolisme, Laboratoires NUTRICIA
- Responsible party
- Sponsor
- Investigators
- Corinne BOUTELOUP, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01955772
- Sponsor's protocol ID
- CHU-0165
- Other IDs
- 2011-A1288-33
- Acronym
- NEPHA
- Status last verified
- Jul 2016
- First submitted
- 19 Jul 2013
- Last updated
- 29 Jul 2016
- Results posted
- No
Publications
Lemal R, Cabrespine A, Pereira B, Combal C, Ravinet A, Hermet E, Bay JO, Bouteloup C. Could enteral nutrition improve the outcome of patients with haematological malignancies undergoing allogeneic haematopoietic stem cell transplantation? A study protocol for a randomized controlled trial (the NEPHA study). Trials. 2015 Apr 7;16:136. doi: 10.1186/s13063-015-0663-8.
PubMed 25872934
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Prospective, Multicenter Study to Compare Enteral Nutrition to Parenteral Nutrition as Feeding Support in Patients Presenting Malignant Hemopathy Who Underwent an Allogeneic Hematopoietic Stem Cell Transplantation.
- ClinicalTrials.gov ID
- NCT01955772
- Acronym / sponsor ID
- NEPHA / CHU-0165
- Conditions
- Myeloablative Allo-SCT
- Keywords
- Haematopoietic stem cell transplantation, Malignant hemopathy, Artificial nutrition
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Societe Francaise de Greffe de Moelle et de Therapie Cellulaire, Société Francophone Nutrition Clinique et Métabolisme, Laboratoires NUTRICIA
- Study start
- Nov 2013
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 8 Oct 2013 (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.
Myeloablative allogeneic hematopoetic stem cell transplantation (AHSCT) are prone to frequent secondary malnutrition to metabolic and digestive troubles due to conditioning regimen, treatments (antibiotics, immunosuppressive therapy…) and graft complications (graft versus host disease). In the absence of appropriate nutritional support, myeloablative conditioning lead to a rapid serious denutrition. But, it is known as negative independent prognostic factor of overall survival of patients who presented malignant hemopathy treated by high-dose chemotherapy or AHSCT. Furthermore, it increases hospitalisation delay and decreases quality of life. In AHSCT with myeloablative conditioning, introduction of nutritional support is recommended. However, type of nutritional support remains not clearly defined. Parenteral nutrition is user but favour infections and secondary effects potentially decrease by intravenous glutamine. Few previous studies with low number of patients, mainly retrospective or combining allo-and auto HSCT had shown feasibility, acceptable tolerance and low cost of enteral nutrition (EN). A recent prospective no-randomized study in 45 adults patients who had undergone AHSCT with myeloablative conditioning find a significant decrease of day-100 mortality (5% vs 30%), of infection mortality, of median duration of parenteral nutrition (PN) and prevalence of GvH (Graft versus Host Disease) grade III-IV in EN (enteral nutrition) group. These results had to be confirmed by a randomized study. As EN is 4 to 5 more cheaply than PN, besides mortality/morbidity stakes for the patient, this study could have potential economic interest.
Detailed description
EN (enteral nutrition) or PN (parenteral nutrition) artificial nutrition will be launched at D1-D2 of the transplantation (D0 being the day of the transplantation),without taking into account the oral intake. This helps in particular to launch the EN after the stage of significant digestive problems related to the conditioning and before the mucositis appearance.
EN group: According to the HAS and SFNEP (Societe francophone nutrition clinique) recommendations and the good practice rules, a polyurethane or silicone NGT(Naso gastric tube), 8 to 10 French units, will be inserted and its positioning will be controlled by radiography before the EN beginning. Polyurethane and silicone are very well tolerated by nasal and oesophagus mucosa and have a long life duration allowing keeping the same tube during 2 to 3 months.
PN group: PN will be administrated by a central venous catheter, which is usually inserted in allo-HSCT patients to allow the administration of chemotherapy and of the different parenteral treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EN (Enteral Nutrition) | Experimental | Drug: Enteral nutrition alanyl-glutamin, DipeptivenNE group: According to the HAS and SFNEP recommendations and the good practice rules, a polyurethane or silicone NGT, 8 to 10 French units, will be inserted and its positioning will be controlled by radiography before the EN beginning. Polyurethane and silicone are very well tolerated by nasal and oesophagus mucosa and have a long life duration allowing keeping the same tube during 2 to 3 months. PN group: PN will be administrated by a central venous catheter, which is usually inserted in allo-HSCT patients to allow the administration of chemotherapy and of the different parenteral treatments. |
| PN (Parenteral Nutrition) | Other | Drug: Enteral nutrition alanyl-glutamin, DipeptivenNE group: According to the HAS and SFNEP recommendations and the good practice rules, a polyurethane or silicone NGT, 8 to 10 French units, will be inserted and its positioning will be controlled by radiography before the EN beginning. Polyurethane and silicone are very well tolerated by nasal and oesophagus mucosa and have a long life duration allowing keeping the same tube during 2 to 3 months. PN group: PN will be administrated by a central venous catheter, which is usually inserted in allo-HSCT patients to allow the administration of chemotherapy and of the different parenteral treatments. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age between 18 and 65 years
- Men and women
- Patients undergoing myeloablative allo-SCT
- Allo-SCT genoidentical or phenoidentical 10/10
- Patients affiliated with a social security organisation
Key exclusion criteria (9 listed)
- Status of tumour progression at the moment of the allo-SCT
- Artificial nutrition begun before the inclusion
- Inability to understand the protocol (linguistic barrier, cognitive difficulties)
- Contraindication or associated pathology that does not allow to carry out EN or PN according to the protocol
- Medical history of progressive psychiatric illness
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 |
|---|---|---|
| Enteral nutrition alanyl-glutamin, DipeptivenAlso: All patients will received, whatever treatment arm, intravenous alanyl-glutamin, Dipeptiven which have AMM.Enteral nutrition versus parenteral nutrition | Drug | EN (Enteral Nutrition), PN (Parenteral Nutrition) |
Primary outcome
Mortality related to the transplant
Time frame: at day 100
6 secondary outcomes
Occurrence of post-transplant complications targeting acute GVH, mucite and infections
Time frame: 12 months after AHSCT (hematopoietic stem cell transplantation)
Overall survival and disease free survival
Time frame: 12 months after AHSCT (hematopoietic stem cell transplantation)
Evolution of nutritional state
Time frame: 12 months after AHSCT
Tolerance of nutritional support mainly on digestive and hepatobiliary disorders
Time frame: 12 months after AHSCT
Engraftment rates
Time frame: Day30, Day60, Day90 and Day180
quality of life assessment
Time frame: Day7, Day90, Day180 and Day360
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2016.
- Derived from this study: PubMed 25872934Lemal R, Cabrespine A, Pereira B, Combal C, Ravinet A, Hermet E, Bay JO, Bouteloup C. Could enteral nutrition improve the outcome of patients with haematological malignancies undergoing allogeneic haematopoietic stem cell transplantation? A study protocol for a randomized controlled trial (the NEPHA study). Trials. 2015 Apr 7;16:136. doi: 10.1186/s13063-015-0663-8.
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.
Corinne BOUTELOUP principal investigator
University Hospital, Clermont-Ferrand
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 Enteral nutrition alanyl-glutamin, Dipeptiven in people with Myeloablative Allo-SCT, run by University Hospital, Clermont-Ferrand 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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 29 Jul 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality related to the transplant (time frame: at day 100). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01955772, which also lists 1 linked publication.
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 29 Jul 2016.