Nutrition and Outcomes of Hematopoietic Cell Transplantation (HCT)

September 26, 2019 updated by: JBeckerson, Imperial College Healthcare NHS Trust

Route and Adequacy of Nutrition and Outcomes of Haematopoietic Cell Transplantation in Patients With Haematological Neoplasms

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

484

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients aged 17 or above who underwent their first HCT for hematologic malignancy at Hammersmith Hospital, using a sibling or unrelated donor between January 2000 and December 2014

Description

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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.
100 days after the date of hematopoietic cell infusion
Non Relapse Mortality
Time Frame: 100 days after the date of hematopoietic cell infusion
Defined as death without previous relapse
100 days after the date of hematopoietic cell infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Graft Versus Host Disease-free and Relapse-free Survival
Time Frame: 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 years after the date of hematopoietic cell infusion
5 Year Survival
Time Frame: 5 years after the date of hematopoietic cell infusion
5 years after the date of hematopoietic cell infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College Healthcare NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2015

Primary Completion (ACTUAL)

June 1, 2016

Study Completion (ACTUAL)

November 1, 2016

Study Registration Dates

First Submitted

January 26, 2018

First Submitted That Met QC Criteria

January 26, 2018

First Posted (ACTUAL)

February 1, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 21, 2019

Last Update Submitted That Met QC Criteria

September 26, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15HH2638

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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