Recruiting

Enteral vs Parenteral

Sponsor:

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

Code:

NCT04024618

Conditions

Malignant Hematologic Neoplasm

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Parenteral Nutrition/Enteral Nutrition

Study Details

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

Study ID

NCT04024618

Start date

Aug 20, 2019

Status verified date

Jul, 2019

Completion date

Dec 31, 2020

Anticipated

Primary completion date

Aug 30, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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 measure

  • Enrollment of patients [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Uday Deotare, MD

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

Maisam Abouzeenni, BHS

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

Locations

London Health Sciences Centre-Victoria Hospital

Recruiting

London, Ontario, Canada, N6A 5W9

Contacts

Uday Deotare, MD

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

More Information

Sponsor

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

Last update posted

Mar 31, 2020

Last verified

Jul, 2019

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2020-03-31.