Feasibility Study Comparing Enteral vs Parenteral Nutritional Outcomes in Autologous Stem Cell Transplant Patients
NCT ID: NCT04024618
Last Updated: 2020-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2019-08-20
2020-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Parenteral Nutrition
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.
Parenteral Nutrition/Enteral Nutrition
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.
Enteral Nutrition
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.
Parenteral Nutrition/Enteral Nutrition
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.
Interventions
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Parenteral Nutrition/Enteral Nutrition
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
OTHER
Responsible Party
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Locations
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London Health Sciences Centre-Victoria Hospital
London, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Gisselbrecht 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.
Lipkin 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.
Buono 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.
Deeg 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.
August 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.
Roberts 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.
Bozzetti 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.
Seguy 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.
Lach 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.
Seguy 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.
Zhang 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.
Beckerson 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.
Kiss 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.
Barbosa-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.
Tillquist M, Kutsogiannis DJ, Wischmeyer PE, Kummerlen C, Leung R, Stollery D, Karvellas CJ, Preiser JC, Bird N, Kozar R, Heyland DK. Bedside ultrasound is a practical and reliable measurement tool for assessing quadriceps muscle layer thickness. JPEN J Parenter Enteral Nutr. 2014 Sep;38(7):886-90. doi: 10.1177/0148607113501327. Epub 2013 Aug 26.
Other Identifiers
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LHSC BMT19.01
Identifier Type: -
Identifier Source: org_study_id
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