Nutrition and Outcomes of Hematopoietic Cell Transplantation (HCT)

Completed

• Conditions: Allogeneic Stem Cell Transplant; Hematologic Malignancy; Graft Versus Host Disease; Stem Cell Transplant Complications

• Registration Number: NCT03419078
• Lead Sponsor: Imperial College Healthcare NHS Trust

Brief Summary

Retrospective case-note review to determine if nutrition via the enteral compared to the parenteral route results in better outcomes after haematopoietic cell transplantation.

Detailed Description

This is a retrospective case-note review of adults undergoing haematopoietic cell transplantation to treat a haematological malignancy who have been admitted to Hammersmith Hospital from 2000 to 2014. All patients receiving an allogeneic haematopoietic cell transplant from a matched sibling or identically matched unrelated donor will be included. We will record the route and assess the broad adequacy of nutritional intakes to determine if nutrition via the enteral compared to the parenteral route results in better outcomes after haematopoietic cell transplantation. Our outcomes are graft versus host disease incidence and severity, transplant related (early) mortality and overall survival.

Study Timeline

• Study Start: 2015-12
• Primary Completion: 2016-06
• Study Completion: 2016-11
• Study First Submitted: 2018-01-26
• Study First Submitted QC: 2018-01-26
• Study First Posted: 2018-02-01
• Results First Submitted: 2019-06-17
• Status Verified: 2019-09
• Results First Submitted QC: 2019-09-26
• Last Update Submitted: 2019-09-26
• Results First Posted: 2019-10-21
• Last Update Posted: 2019-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 484

Inclusion Criteria

• Patients undergoing their first HCT for a hematologic malignancy
• Undergoing HCT using a sibling or unrelated donor
• Undergoing HCT infusion between January 2000 and December 2014

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Exclusion Criteria

• HCT using umbilical cord blood donors
• HCT using haploidentical donors

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants With Acute Graft Versus Host Disease (GvHD) at Any Site (Grade II or Above) and Acute GvHD of the Gut of Any Grade	100 days after the date of hematopoietic cell infusion	Occurrence of acute GvHD at any site (grade II or above) and acute GvHD of the gut of any grade (graded according to standard criteria). Standard criteria to grade the severity of acute GvHD are quantification of rash, serum bilirubin and diarrhoea. These standard criteria have been developed and used for \> 20 years by most transplant centres to improve comparability between publications.
Non Relapse Mortality	100 days after the date of hematopoietic cell infusion	Defined as death without previous relapse

Secondary Outcome Measures

Name	Time	Method
Graft Versus Host Disease-free and Relapse-free Survival	5 years after the date of hematopoietic cell infusion	GvHD-free/relapse-free survival (GRFS). Events in GRFS included grade 3-4 acute GvHD, systemic therapy-requiring chronic GvHD, relapse, or death
5 Year Survival	5 years after the date of hematopoietic cell infusion