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Trial record 30 of 1319 for:    Hematologic neoplasm

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

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ClinicalTrials.gov Identifier: NCT04024618
Recruitment Status : Not yet recruiting
First Posted : July 18, 2019
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
Uday Deotare, Lawson Health Research Institute

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 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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
Estimated Study Start Date : August 30, 2019
Estimated Primary Completion Date : May 20, 2020
Estimated Study Completion Date : December 31, 2021


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.




Primary Outcome Measures :
  1. Enrollment of patients [ Time Frame: 30 days ]
    The number of patients enrolled


Secondary Outcome Measures :
  1. quadriceps muscle layer thickness [ Time Frame: 21 days ]
    Maintenance and/or improvement of quadriceps muscle layer thickness (QMLT) measurement: measured by ultrasound.

  2. Duration of Support [ Time Frame: 21 days ]
    A comparison of duration in days a patient will require enteral or parenteral nutritional support during their admission.

  3. Changes in costs [ Time Frame: 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.

  4. Hospital Stay [ Time Frame: 21 days ]
    Length of hospital stay (decrease by 1+/-2 days)

  5. Mortality [ Time Frame: 30 days ]
    Mortality on Day+30 Post AHSCT

  6. Changes in body fat [ Time Frame: 21 Days ]
    Measuring the changes in percentage of body fat mass using Bioelectric Impedance Analysis

  7. Changes in Lean Muscle [ Time Frame: 21 Days ]
    Measuring the changes in percentage lean muscle mass using Bioelectric Impedance Analysis

  8. Changes in costs to hospital when using enteral nutritional [ Time Frame: 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

  9. Transition from EN to oral feeding [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04024618


Contacts
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Contact: Uday Deotare, MD 519-685-8500 ext 58479 Uday.Deotare@lhsc.on.ca
Contact: Maisam Abouzeenni, BHS 519-685-8500 ext 56840 Maisam.Abouzeenni@lhsc.on.ca

Sponsors and Collaborators
Lawson Health Research Institute

Publications:

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Responsible Party: Uday Deotare, Hematologist, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT04024618     History of Changes
Other Study ID Numbers: LHSC BMT19.01
First Posted: July 18, 2019    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The investigators do not plan on sharing individual participant data to other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Uday Deotare, Lawson Health Research Institute:
Non- Hodgkin's Lymphoma
Hodgkin's Lymphoma
Multiple Myeloma
AHSCT
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neoplasms by Site
Neoplasms
Hematologic Diseases