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

Malignant Hematologic Neoplasm Clinical Trial

Official title:

A Pilot Feasibility Study of Nutritional Outcomes in Autologous Hematopoietic Stem Cell Transplant Recipients Comparing Enteral Nutrition Versus Parenteral Nutrition

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04024618
• Other study ID #: LHSC BMT19.01
• Status: Recruiting
• Phase: N/A
• Start date: August 20, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: July 2019
• Source: Lawson Health Research Institute
• Contact: Uday Deotare, MD
• Phone: 519-685-8500
• Email: Uday.Deotare[@]lhsc.on.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2020
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Malignant Hematologic Neoplasm

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Canada	London Health Sciences Centre-Victoria Hospital	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

References & Publications (16)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Seguy D, Berthon C, Micol JB, Darré 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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enrollment of patients	The number of patients enrolled	30 days
Secondary	quadriceps muscle layer thickness	Maintenance and/or improvement of quadriceps muscle layer thickness (QMLT) measurement: measured by ultrasound.	21 days
Secondary	Duration of Support	A comparison of duration in days a patient will require enteral or parenteral nutritional support during their admission.	21 days
Secondary	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.	21 days
Secondary	Hospital Stay	Length of hospital stay (decrease by 1+/-2 days)	21 days
Secondary	Mortality	Mortality on Day+30 Post AHSCT	30 days
Secondary	Changes in body fat	Measuring the changes in percentage of body fat mass using Bioelectric Impedance Analysis	21 Days
Secondary	Changes in Lean Muscle	Measuring the changes in percentage lean muscle mass using Bioelectric Impedance Analysis	21 Days
Secondary	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	21 Days
Secondary	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.	15 Days