Clinical trial NCT04024618: Feasibility Study Comparing Enteral vs Parenteral Nutritional Outcomes in Autologous Stem Cell Transplant Patients
Official title: A Pilot Feasibility Study of Nutritional Outcomes in Autologous Hematopoietic Stem Cell Transplant Recipients Comparing Enteral Nutrition Versus Parenteral Nutrition
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Malignant Hematologic Neoplasm
Keywords: Non- Hodgkin's Lymphoma
Hodgkin's Lymphoma
Multiple Myeloma
AHSCT
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2019-07-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization will be 1:1, both EN and PN arms. The patients will be randomized in permutated blocks independently by Statistician.
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Enrollment of patients
timeFrame: 30 days
Secondary outcomes:
measure: quadriceps muscle layer thickness
timeFrame: 21 days
measure: Duration of Support
timeFrame: 21 days
measure: Changes in costs
timeFrame: 21 days
measure: Hospital Stay
timeFrame: 21 days
measure: Mortality
timeFrame: 30 days
measure: Changes in body fat
timeFrame: 21 Days
measure: Changes in Lean Muscle
timeFrame: 21 Days
measure: Changes in costs to hospital when using enteral nutritional
timeFrame: 21 Days
measure: Transition from EN to oral feeding
timeFrame: 15 Days
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre-Victoria Hospital
state: Ontario
Study officials:
References:
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