Nutrition and Outcomes of Hematopoietic Cell Transplantation (HCT)

NCT03419078 | Completed Results

• 1 other identifier: 15HH2638
• Study Type: observational
• Target: 484
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

enteral nutrition; parenteral nutrition; artificial nutrition support; non-relapse mortality; survival

Outcome Measures

Primary Outcomes (2)

• 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

• Non Relapse Mortality

  Defined as death without previous relapse

  100 days after the date of hematopoietic cell infusion

Secondary Outcomes (2)

• Graft Versus Host Disease-free and Relapse-free Survival

  5 years after the date of hematopoietic cell infusion

• 5 Year Survival

  5 years after the date of hematopoietic cell infusion

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Imperial College Healthcare NHS Trust: lead

MeSH Terms

Conditions

Graft vs Host Disease; Hematologic Neoplasms; Hyperphagia

Condition Hierarchy (Ancestors)

Immune System Diseases; Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Julie Beckerson
• Organization: Imperial College Healthcare NHS Trust

julie.beckerson@nhs.net

02033131922

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Haemato-Oncology Specialist Dietitian

Study Record Dates

• First Submitted: January 26, 2018
• First Posted: February 1, 2018
• Study Start: December 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: November 1, 2016
• Last Updated: October 21, 2019
• Results First Posted: October 21, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share