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

Sponsor

Lawson Health Research Institute (Other)

Overall Status

Unknown status

CT.gov ID

NCT04024618

Collaborator

(none)

Enrollment

Location

Arms

16.4

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Malignant Hematologic Neoplasm	Procedure: Parenteral Nutrition/Enteral Nutrition	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 20, 2019

Anticipated Primary Completion Date :

Aug 30, 2020

Anticipated Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	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.
Experimental: 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.	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.

Arm

Intervention/Treatment

Active Comparator: 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.

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.

Experimental: 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.

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.

Outcome Measures

Primary Outcome Measures

Enrollment of patients [30 days]
The number of patients enrolled

Secondary Outcome Measures

quadriceps muscle layer thickness [21 days]
Maintenance and/or improvement of quadriceps muscle layer thickness (QMLT) measurement: measured by ultrasound.
Duration of Support [21 days]
A comparison of duration in days a patient will require enteral or parenteral nutritional support during their admission.
Changes in costs [21 days]
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.
Hospital Stay [21 days]
Length of hospital stay (decrease by 1+/-2 days)
Mortality [30 days]
Mortality on Day+30 Post AHSCT
Changes in body fat [21 Days]
Measuring the changes in percentage of body fat mass using Bioelectric Impedance Analysis
Changes in Lean Muscle [21 Days]
Measuring the changes in percentage lean muscle mass using Bioelectric Impedance Analysis
Changes in costs to hospital when using enteral nutritional [21 Days]
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
Transition from EN to oral feeding [15 Days]
Successful transition from EN to oral feeding versus Parenteral Nutrition to oral feeding defined by 50% oral intake on Day+15 of AHSCT.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	London Health Sciences Centre-Victoria Hospital	London	Ontario	Canada	N6A 5W9

Sponsors and Collaborators

Lawson Health Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Lawson Health Research Institute

ClinicalTrials.gov Identifier:

NCT04024618

Other Study ID Numbers:

LHSC BMT19.01

First Posted:

Jul 18, 2019

Last Update Posted:

Mar 31, 2020

Last Verified:

Jul 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Lawson Health Research Institute

Non- Hodgkin's Lymphoma

Hodgkin's Lymphoma

Multiple Myeloma

AHSCT

Additional relevant MeSH terms:

Hematologic Neoplasms

Study Results

No Results Posted as of Mar 31, 2020