Nutrition and Outcomes of Hematopoietic Cell Transplantation (HCT)

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

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Key information

Conditions

Allogeneic Stem Cell Transplant Graft Versus Host Disease Graft vs Host Disease Hematologic Diseases Hematologic Malignancy Hematologic Neoplasms Hemic and Lymphatic Diseases Hyperphagia Immune System Diseases Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Stem Cell Transplant Complications

Age range

17 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.
Non Relapse Mortality

Time frame: 100 days after the date of hematopoietic cell infusion

Defined as death without previous relapse

Secondary outcomes

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 Year Survival

Time frame: 5 years after the date of hematopoietic cell infusion

Sponsors and collaborators

Lead sponsor

Imperial College Healthcare NHS Trust

Other

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Feb 1, 2018
Registry last updated: Oct 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed