Nutrition and Outcomes of Hematopoietic Cell Transplantation (HCT)

Graft Versus Host Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03419078
• Other study ID #: 15HH2638
• Status: Completed
• Start date: December 2015
• Est. completion date: November 2016

Study information

• Verified date: September 2019
• Source: Imperial College Healthcare NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 484
• Est. completion date: November 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Allogeneic Stem Cell Transplant
• Graft Versus Host Disease
• Graft vs Host Disease
• Hematologic Malignancy
• Stem Cell Transplant Complications

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College Healthcare NHS Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Primary	Non Relapse Mortality	Defined as death without previous relapse	100 days after the date of hematopoietic cell infusion
Secondary	Graft Versus Host Disease-free and Relapse-free Survival	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
Secondary	5 Year Survival		5 years after the date of hematopoietic cell infusion