Feasibility Study Comparing Enteral vs Parenteral Nutritional Outcomes in Autologous Stem Cell Transplant Patients

NCT04024618 | Unknown DMC

• 1 other identifier: LHSC BMT19.01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Malignant Hematologic Neoplasm

Keywords

Non- Hodgkin's Lymphoma; Hodgkin's Lymphoma; Multiple Myeloma; AHSCT

Outcome Measures

Primary Outcomes (1)

• Enrollment of patients

  The number of patients enrolled

  30 days

Secondary Outcomes (9)

• quadriceps muscle layer thickness

  21 days

• Duration of Support

  21 days

• Changes in costs

  21 days

• Hospital Stay

  21 days

• Mortality

  30 days

Study Arms (2)

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.

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.

Procedure: Parenteral Nutrition/Enteral Nutrition

Interventions

Parenteral Nutrition/Enteral Nutrition PROCEDURE

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; Parenteral Nutrition

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

London Health Sciences Centre-Victoria Hospital

London, Ontario, N6A 5W9, Canada

RECRUITING

Related Publications (16)

• 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.

  PMID: 30129104 BACKGROUND

• 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.

  PMID: 29808921 BACKGROUND

• 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.

  PMID: 16207682 BACKGROUND

• 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.

  PMID: 29463451 BACKGROUND

• 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.

  PMID: 7599573 BACKGROUND

• 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.

  PMID: 19713551 BACKGROUND

• 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.

  PMID: 13130320 BACKGROUND

• 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.

  PMID: 11705560 BACKGROUND

• 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.

  PMID: 17006332 BACKGROUND

• 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.

  PMID: 28633000 BACKGROUND

• 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.

  PMID: 22785249 BACKGROUND

• 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.

  PMID: 30098572 BACKGROUND

• 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.

  PMID: 29650256 BACKGROUND

• 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.

  PMID: 24764716 BACKGROUND

• 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.

  PMID: 16002799 BACKGROUND

• 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.

  PMID: 23980134 BACKGROUND

MeSH Terms

Conditions

Hematologic Neoplasms; Lymphoma, Non-Hodgkin; Hodgkin Disease; Multiple Myeloma

Interventions

Parenteral Nutrition; Enteral Nutrition

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoma; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy

Central Study Contacts

Uday Deotare, MD

CONTACT

519-685-8500; Uday.Deotare@lhsc.on.ca

Maisam Abouzeenni, BHS

CONTACT

519-685-8500; Maisam.Abouzeenni@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomization will be 1:1, both EN and PN arms. The patients will be randomized in permutated blocks independently by Statistician.

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: July 18, 2019
• Study Start: August 20, 2019
• Primary Completion: August 30, 2020
• Study Completion: December 31, 2020
• Last Updated: March 31, 2020

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)