Malignant Hematologic NeoplasmNCT04024618
Feasibility Study Comparing Enteral vs Parenteral Nutritional Outcomes in Autologous Stem Cell Transplant Patients
A study testing Parenteral Nutrition/Enteral Nutrition in people with Malignant Hematologic Neoplasm, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
This study will highlight that Enteral Nutrition (EN) is as effective in nutritionally supporting as Parenteral Nutrition (PN) in this group of patients undergoing an autologous hematopoietic stem cell transplantation (AHSCT). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Malignant Hematologic Neoplasm
- What is being tested?
- Parenteral Nutrition/Enteral Nutrition
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 20 Aug 2019to 31 Dec 2020
- Phase
- Interventional
- 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
- All adult patients aged 18 to 75 years.
- Patients admitted to Victoria Hospital undergoing AHSCT on C7 unit.
- Patient consented to participate in the study
- Patients diagnosed with the following conditions: Non- Hodgkin's Lymphoma (all types), Hodgkin's Lymphoma (all subtypes) and Multiple Myeloma
- Patients receiving any of the following: Conditioning chemotherapy: Melphalan, Etoposide/Melphalan, or Carmustine, Etoposide, Cytarabine, Melphalan
- Have a functional Gastrointestinal tract
Who cannot join
- Intestinal obstruction
- Patients with nasal deformities, tumors of nasal tracts or upper nare obstruction.
- Patients with active bacteremia while proceeding with transplant
- Patients with active malignancy of Upper GI tract, not in remission as evidenced by recent imaging studies (< 4 weeks)
- Patients with any GI bleeding, paralytic ileus, obstruction, or any other GI condition which excludes use of the GI system for nutritional support as these patients will require PN feeding only and cannot be randomized
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
London Health Sciences Centre-Victoria Hospital
London, Ontario, N6A 5W9
Uday Deotare, MD, 519-685-8500 ext. 76616, Uday.Deotare@lhsc.on.ca
About this study
Official title: A Pilot Feasibility Study of Nutritional Outcomes in Autologous Hematopoietic Stem Cell Transplant Recipients Comparing Enteral Nutrition Versus Parenteral Nutrition
This study will highlight that Enteral Nutrition (EN) is as effective in nutritionally supporting as Parenteral Nutrition (PN) in this group of patients undergoing an autologous hematopoietic stem cell transplantation (AHSCT). The rationale of this study is to compare nutritional, medical, cost and Quality of Life (QOL) outcomes in patients receiving either EN or PN nutritional support in patients. The main outcomes are to examine are nutritional status, medical complications, cost and QOL before and after AHSCT.
Read the detailed description
This will be a pilot open randomized study. The study will be conducted at the inpatient setting at London Health Sciences Centre in London, ON. Forty patients will be randomized in permutated blocks independently by Statistician, to either the EN or PN group on admission to the unit. The baseline evaluations are blood work, Bioelectric Impedance Analysis (BIA), Subjective Global Assessment (SGA), Body Mass Index (BMI) calculation, ultrasound, and a medical evaluation. Patients do have the right to refuse either or both types of nutritional support. As part of standard care, the risks and benefits of nutritional support for both EN and PN will be explained to the patient.
Consent will be obtained prior to admission. Most of these patients initially continue to maintain their oral intake even after chemotherapy. On Day 5+/- 1 day after transplantation, the randomized nutrition therapy will only be initiated only if patient intake is < 80% of usual intake, where they will be provided with 25-35 kcal/kg/day, 1.2-1.5g of protein/kg/day, and omega-3 to supplement any oral intake the patient might not have. If the intake is >80% of required intake, initiation of randomized therapy will only happen on the day the intake falls to <80% of required nutritional intake.
Patients will be monitored until Day 15 where post-transplant evaluations will be conducted: blood work, BIA, SGA, ultrasound, BMI, food records, and medical evaluation. If at that time, patients are not consuming 50% of energy from oral feeds, nutrition therapy will continue until oral goal is met or until discharge for medical reasons. Patients will be assessed at Day+30 post-transplant in clinic and the following will be completed blood work, BIA, SGA, BMI, food records, ultrasound, medical complications and a QOL assessment.
- Conditions
- Malignant Hematologic Neoplasm
- Being tested
- Parenteral Nutrition/Enteral Nutrition
- Keywords
- Non- Hodgkin's Lymphoma, Hodgkin's Lymphoma, Multiple Myeloma, AHSCT
- Medical subject headings
- Hematologic Neoplasms, Lymphoma, Non-Hodgkin, Hodgkin Disease, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parenteral Nutrition/Enteral NutritionProcedure or surgery
Patients randomized to the parenteral nutrition arm will receive nutrition by IV and patients randomized to the enteral nutrition arm will receive nutrition by NG tube.
| Study group | Role | What they receive |
|---|---|---|
| Parenteral Nutrition | Active comparator | Patients who have been randomized to receive PN will be started on day 5 post AHSCT. This will be if patient intake is < 80% of usual oral intake at that time. The central venous catheter required for PN administration will be already in place for AHSCT treatment, prior to admission and pre-transplant evaluation. Nutritional support will continue until oral intake is >50% or until the patient is ready for discharge if intake remains < 50% of recommendations. Receives: Procedure: Parenteral Nutrition/Enteral Nutrition |
| Enteral Nutrition | Experimental | Patients who have been randomized to receive EN will have a Nasogastric tube (NGT) inserted on day 5 post AHSCT, prior to start of Enteral feeds. This would be a polyurethane tube, 8-10 French, which will be inserted by physician or Nurse Practitioner with position confirmed by radiological examination. This will be if patient intake is < 80% of usual oral intake at that time. Nutritional support will continue until oral intake is >50% or until the patient is ready for discharge if intake remains < 50% of recommendations. Receives: Procedure: Parenteral Nutrition/Enteral Nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment of patients
The number of patients enrolled
Measured: 30 days
Secondary outcomes (9)
quadriceps muscle layer thickness
Maintenance and/or improvement of quadriceps muscle layer thickness (QMLT) measurement: measured by ultrasound.
Measured: 21 days
Duration of Support
A comparison of duration in days a patient will require enteral or parenteral nutritional support during their admission.
Measured: 21 days
Changes in costs
The cost of daily total PN is $80/day and cost of EN feeds would be $40/day. This is a 50% change in costs.
Measured: 21 days
Hospital Stay
Length of hospital stay (decrease by 1+/-2 days)
Measured: 21 days
Mortality
Mortality on Day+30 Post AHSCT
Measured: 30 days
Changes in body fat
Measuring the changes in percentage of body fat mass using Bioelectric Impedance Analysis
Measured: 21 Days
Changes in Lean Muscle
Measuring the changes in percentage lean muscle mass using Bioelectric Impedance Analysis
Measured: 21 Days
Changes in costs to hospital when using enteral nutritional
the measurement the length of their stay in the hospital by days, fewer days of hospitalization = lower costs and more days of hospitalization = greater costs
Measured: 21 Days
Transition from EN to oral feeding
Successful transition from EN to oral feeding versus Parenteral Nutrition to oral feeding defined by 50% oral intake on Day+15 of AHSCT.
Measured: 15 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start20 Aug 2019
- Primary completion30 Aug 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Malignant Hematologic NeoplasmStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization will be 1:1, both EN and PN arms. The patients will be randomized in permutated blocks independently by Statistician.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04024618
- Sponsor's protocol ID
- LHSC BMT19.01
- Status last verified
- Jul 2019
- First submitted
- 24 Apr 2019
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators do not plan on sharing individual participant data to other researchers
Publications
Sekine L, Ziegelmann PK, Manica D, da Fonte Pithan C, Sosnoski M, Morais VD, Falcetta FS, Ribeiro MR, Salazar AP, Ribeiro RA. Frontline treatment for transplant-eligible multiple myeloma: A 6474 patients network meta-analysis. Hematol Oncol. 2019 Feb;37(1):62-74. doi: 10.1002/hon.2552. Epub 2018 Sep 20.
PubMed 30129104Gisselbrecht C, Van Den Neste E. How I manage patients with relapsed/refractory diffuse large B cell lymphoma. Br J Haematol. 2018 Sep;182(5):633-643. doi: 10.1111/bjh.15412. Epub 2018 May 29.
PubMed 29808921Lipkin AC, Lenssen P, Dickson BJ. Nutrition issues in hematopoietic stem cell transplantation: state of the art. Nutr Clin Pract. 2005 Aug;20(4):423-39. doi: 10.1177/0115426505020004423.
PubMed 16207682Buono R, Longo VD. Starvation, Stress Resistance, and Cancer. Trends Endocrinol Metab. 2018 Apr;29(4):271-280. doi: 10.1016/j.tem.2018.01.008. Epub 2018 Feb 17.
PubMed 29463451Deeg HJ, Seidel K, Bruemmer B, Pepe MS, Appelbaum FR. Impact of patient weight on non-relapse mortality after marrow transplantation. Bone Marrow Transplant. 1995 Mar;15(3):461-8.
PubMed 7599573August DA, Huhmann MB; American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) Board of Directors. A.S.P.E.N. clinical guidelines: nutrition support therapy during adult anticancer treatment and in hematopoietic cell transplantation. JPEN J Parenter Enteral Nutr. 2009 Sep-Oct;33(5):472-500. doi: 10.1177/0148607109341804. No abstract available.
PubMed 19713551Roberts S, Miller J, Pineiro L, Jennings L. Total parenteral nutrition vs oral diet in autologous hematopoietic cell transplant recipients. Bone Marrow Transplant. 2003 Oct;32(7):715-21. doi: 10.1038/sj.bmt.1704204.
PubMed 13130320Bozzetti F, Braga M, Gianotti L, Gavazzi C, Mariani L. Postoperative enteral versus parenteral nutrition in malnourished patients with gastrointestinal cancer: a randomised multicentre trial. Lancet. 2001 Nov 3;358(9292):1487-92. doi: 10.1016/S0140-6736(01)06578-3.
PubMed 11705560Seguy D, Berthon C, Micol JB, Darre S, Dalle JH, Neuville S, Bauters F, Jouet JP, Yakoub-Agha I. Enteral feeding and early outcomes of patients undergoing allogeneic stem cell transplantation following myeloablative conditioning. Transplantation. 2006 Sep 27;82(6):835-9. doi: 10.1097/01.tp.0000229419.73428.ff.
PubMed 17006332Lach K, Peterson SJ. Nutrition Support for Critically Ill Patients With Cancer. Nutr Clin Pract. 2017 Oct;32(5):578-586. doi: 10.1177/0884533617712488. Epub 2017 Jun 20.
PubMed 28633000Seguy D, Duhamel A, Rejeb MB, Gomez E, Buhl ND, Bruno B, Cortot A, Yakoub-Agha I. Better outcome of patients undergoing enteral tube feeding after myeloablative conditioning for allogeneic stem cell transplantation. Transplantation. 2012 Aug 15;94(3):287-94. doi: 10.1097/TP.0b013e3182558f60.
PubMed 22785249Zhang G, Zhang K, Cui W, Hong Y, Zhang Z. The effect of enteral versus parenteral nutrition for critically ill patients: A systematic review and meta-analysis. J Clin Anesth. 2018 Dec;51:62-92. doi: 10.1016/j.jclinane.2018.08.008. Epub 2018 Aug 8.
PubMed 30098572Beckerson J, Szydlo RM, Hickson M, Mactier CE, Innes AJ, Gabriel IH, Palanicawandar R, Kanfer EJ, Macdonald DH, Milojkovic D, Rahemtulla A, Chaidos A, Karadimitris A, Olavarria E, Apperley JF, Pavlu J. Impact of route and adequacy of nutritional intake on outcomes of allogeneic haematopoietic cell transplantation for haematologic malignancies. Clin Nutr. 2019 Apr;38(2):738-744. doi: 10.1016/j.clnu.2018.03.008. Epub 2018 Mar 28.
PubMed 29650256Kiss N, Seymour JF, Prince HM, Dutu G. Challenges and outcomes of a randomized study of early nutrition support during autologous stem-cell transplantation. Curr Oncol. 2014 Apr;21(2):e334-9. doi: 10.3747/co.21.1820.
PubMed 24764716Barbosa-Silva MC, Barros AJ, Wang J, Heymsfield SB, Pierson RN Jr. Bioelectrical impedance analysis: population reference values for phase angle by age and sex. Am J Clin Nutr. 2005 Jul;82(1):49-52. doi: 10.1093/ajcn.82.1.49.
PubMed 16002799
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Feasibility Study of Nutritional Outcomes in Autologous Hematopoietic Stem Cell Transplant Recipients Comparing Enteral Nutrition Versus Parenteral Nutrition
- ClinicalTrials.gov ID
- NCT04024618
- Acronym / sponsor ID
- LHSC BMT19.01
- Conditions
- Malignant Hematologic Neoplasm
- Keywords
- Non- Hodgkin's Lymphoma, Hodgkin's Lymphoma, Multiple Myeloma, AHSCT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 20 Aug 2019 (actual)
- Primary completion
- 30 Aug 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 18 Jul 2019 (actual)
- 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.
This study will highlight that Enteral Nutrition (EN) is as effective in nutritionally supporting as Parenteral Nutrition (PN) in this group of patients undergoing an autologous hematopoietic stem cell transplantation (AHSCT). The rationale of this study is to compare nutritional, medical, cost and Quality of Life (QOL) outcomes in patients receiving either EN or PN nutritional support in patients. The main outcomes are to examine are nutritional status, medical complications, cost and QOL before and after AHSCT.
Detailed description
This will be a pilot open randomized study. The study will be conducted at the inpatient setting at London Health Sciences Centre in London, ON. Forty patients will be randomized in permutated blocks independently by Statistician, to either the EN or PN group on admission to the unit. The baseline evaluations are blood work, Bioelectric Impedance Analysis (BIA), Subjective Global Assessment (SGA), Body Mass Index (BMI) calculation, ultrasound, and a medical evaluation. Patients do have the right to refuse either or both types of nutritional support. As part of standard care, the risks and benefits of nutritional support for both EN and PN will be explained to the patient.
Consent will be obtained prior to admission. Most of these patients initially continue to maintain their oral intake even after chemotherapy. On Day 5+/- 1 day after transplantation, the randomized nutrition therapy will only be initiated only if patient intake is < 80% of usual intake, where they will be provided with 25-35 kcal/kg/day, 1.2-1.5g of protein/kg/day, and omega-3 to supplement any oral intake the patient might not have. If the intake is >80% of required intake, initiation of randomized therapy will only happen on the day the intake falls to <80% of required nutritional intake.
Patients will be monitored until Day 15 where post-transplant evaluations will be conducted: blood work, BIA, SGA, ultrasound, BMI, food records, and medical evaluation. If at that time, patients are not consuming 50% of energy from oral feeds, nutrition therapy will continue until oral goal is met or until discharge for medical reasons. Patients will be assessed at Day+30 post-transplant in clinic and the following will be completed blood work, BIA, SGA, BMI, food records, ultrasound, medical complications and a QOL assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization will be 1:1, both EN and PN arms. The patients will be randomized in permutated blocks independently by Statistician.
| Arm | Type | Receives |
|---|---|---|
| Parenteral Nutrition | Active comparator | Procedure: Parenteral Nutrition/Enteral NutritionPatients who have been randomized to receive PN will be started on day 5 post AHSCT. This will be if patient intake is < 80% of usual oral intake at that time. The central venous catheter required for PN administration will be already in place for AHSCT treatment, prior to admission and pre-transplant evaluation. Nutritional support will continue until oral intake is >50% or until the patient is ready for discharge if intake remains < 50% of recommendations. |
| Enteral Nutrition | Experimental | Procedure: Parenteral Nutrition/Enteral NutritionPatients who have been randomized to receive EN will have a Nasogastric tube (NGT) inserted on day 5 post AHSCT, prior to start of Enteral feeds. This would be a polyurethane tube, 8-10 French, which will be inserted by physician or Nurse Practitioner with position confirmed by radiological examination. This will be if patient intake is < 80% of usual oral intake at that time. Nutritional support will continue until oral intake is >50% or until the patient is ready for discharge if intake remains < 50% of recommendations. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- All adult patients aged 18 to 75 years.
- Patients admitted to Victoria Hospital undergoing AHSCT on C7 unit.
- Patient consented to participate in the study
- Patients diagnosed with the following conditions: Non- Hodgkin's Lymphoma (all types), Hodgkin's Lymphoma (all subtypes) and Multiple Myeloma
- Patients receiving any of the following: Conditioning chemotherapy: Melphalan, Etoposide/Melphalan, or Carmustine, Etoposide, Cytarabine, Melphalan
Key exclusion criteria (5 listed)
- Intestinal obstruction
- Patients with nasal deformities, tumors of nasal tracts or upper nare obstruction.
- Patients with active bacteremia while proceeding with transplant
- Patients with active malignancy of Upper GI tract, not in remission as evidenced by recent imaging studies (< 4 weeks)
- Patients with any GI bleeding, paralytic ileus, obstruction, or any other GI condition which excludes use of the GI system for nutritional support as these patients will require PN feeding only and cannot be randomized
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 |
|---|---|---|
| Parenteral Nutrition/Enteral NutritionPatients randomized to the parenteral nutrition arm will receive nutrition by IV and patients randomized to the enteral nutrition arm will receive nutrition by NG tube. | Procedure or surgery | Enteral Nutrition, Parenteral Nutrition |
Primary outcome
Enrollment of patients
Time frame: 30 days
The number of patients enrolled
9 secondary outcomes
quadriceps muscle layer thickness
Time frame: 21 days
Duration of Support
Time frame: 21 days
Changes in costs
Time frame: 21 days
Hospital Stay
Time frame: 21 days
Mortality
Time frame: 30 days
Changes in body fat
Time frame: 21 Days
Changes in Lean Muscle
Time frame: 21 Days
Changes in costs to hospital when using enteral nutritional
Time frame: 21 Days
Transition from EN to oral feeding
Time frame: 15 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
- Background: PubMed 30129104Sekine L, Ziegelmann PK, Manica D, da Fonte Pithan C, Sosnoski M, Morais VD, Falcetta FS, Ribeiro MR, Salazar AP, Ribeiro RA. Frontline treatment for transplant-eligible multiple myeloma: A 6474 patients network meta-analysis. Hematol Oncol. 2019 Feb;37(1):62-74. doi: 10.1002/hon.2552. Epub 2018 Sep 20.
- Background: PubMed 29808921Gisselbrecht C, Van Den Neste E. How I manage patients with relapsed/refractory diffuse large B cell lymphoma. Br J Haematol. 2018 Sep;182(5):633-643. doi: 10.1111/bjh.15412. Epub 2018 May 29.
- Background: PubMed 16207682Lipkin AC, Lenssen P, Dickson BJ. Nutrition issues in hematopoietic stem cell transplantation: state of the art. Nutr Clin Pract. 2005 Aug;20(4):423-39. doi: 10.1177/0115426505020004423.
- Background: PubMed 29463451Buono R, Longo VD. Starvation, Stress Resistance, and Cancer. Trends Endocrinol Metab. 2018 Apr;29(4):271-280. doi: 10.1016/j.tem.2018.01.008. Epub 2018 Feb 17.
- Background: PubMed 7599573Deeg HJ, Seidel K, Bruemmer B, Pepe MS, Appelbaum FR. Impact of patient weight on non-relapse mortality after marrow transplantation. Bone Marrow Transplant. 1995 Mar;15(3):461-8.
- Background: PubMed 19713551August DA, Huhmann MB; American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) Board of Directors. A.S.P.E.N. clinical guidelines: nutrition support therapy during adult anticancer treatment and in hematopoietic cell transplantation. JPEN J Parenter Enteral Nutr. 2009 Sep-Oct;33(5):472-500. doi: 10.1177/0148607109341804. No abstract available.
- Background: PubMed 13130320Roberts S, Miller J, Pineiro L, Jennings L. Total parenteral nutrition vs oral diet in autologous hematopoietic cell transplant recipients. Bone Marrow Transplant. 2003 Oct;32(7):715-21. doi: 10.1038/sj.bmt.1704204.
- Background: PubMed 11705560Bozzetti F, Braga M, Gianotti L, Gavazzi C, Mariani L. Postoperative enteral versus parenteral nutrition in malnourished patients with gastrointestinal cancer: a randomised multicentre trial. Lancet. 2001 Nov 3;358(9292):1487-92. doi: 10.1016/S0140-6736(01)06578-3.
- Background: PubMed 17006332Seguy D, Berthon C, Micol JB, Darre S, Dalle JH, Neuville S, Bauters F, Jouet JP, Yakoub-Agha I. Enteral feeding and early outcomes of patients undergoing allogeneic stem cell transplantation following myeloablative conditioning. Transplantation. 2006 Sep 27;82(6):835-9. doi: 10.1097/01.tp.0000229419.73428.ff.
- Background: PubMed 28633000Lach K, Peterson SJ. Nutrition Support for Critically Ill Patients With Cancer. Nutr Clin Pract. 2017 Oct;32(5):578-586. doi: 10.1177/0884533617712488. Epub 2017 Jun 20.
- Background: PubMed 22785249Seguy D, Duhamel A, Rejeb MB, Gomez E, Buhl ND, Bruno B, Cortot A, Yakoub-Agha I. Better outcome of patients undergoing enteral tube feeding after myeloablative conditioning for allogeneic stem cell transplantation. Transplantation. 2012 Aug 15;94(3):287-94. doi: 10.1097/TP.0b013e3182558f60.
- Background: PubMed 30098572Zhang G, Zhang K, Cui W, Hong Y, Zhang Z. The effect of enteral versus parenteral nutrition for critically ill patients: A systematic review and meta-analysis. J Clin Anesth. 2018 Dec;51:62-92. doi: 10.1016/j.jclinane.2018.08.008. Epub 2018 Aug 8.
- Individual participant dataSharing planned: No. The investigators do not plan on sharing individual participant data to other researchers
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parenteral Nutrition/Enteral Nutrition in people with Malignant Hematologic Neoplasm, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 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: status not confirmed, as of the sponsor's last update on 31 Mar 2020. 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 Canada. 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.
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 Uday Deotare, MD (519-685-8500 ext. 58479, Uday.Deotare@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment of patients (time frame: 30 days). 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 NCT04024618, which also lists 16 linked publications.
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 31 Mar 2020.