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Clinical Trials/NCT05209321
NCT05209321
Completed
Not Applicable

Predictors of Malnutrition in Patients With Haematological Cancer

Jens Rikardt Andersen1 site in 1 country62 target enrollmentApril 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Malnutrition
Sponsor
Jens Rikardt Andersen
Enrollment
62
Locations
1
Primary Endpoint
Loss of Lean Body Mass
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The primary purpose of this study is to conduct an exploratory study of which predictors are most significant for LBM loss in patients with lymphoma. Patients are measured by weight and bio impedance and furthermore, their physical activity, nutritional status, diet and quality of life during the course are estimated. This is done in order to determine any changes in the aforementioned factors during the course of the cancer treatment that may have a bearing on the loss of LBM.

Detailed Description

It was assessed by the National Ethics Committee that the experiment was not subject to notification, cf. section 14 (1) of the Committee Act. 2. The project has been approved by the Ethical Research Committee for SUND and SCIENCE, University of Copenhagen.. The project was also approved by the Danish Data Protection Agency at Region Zealand with case no .: REG-166-2020. A data processor agreement was established between Region Zealand and thesis students. Data is presented as mean +/- SD. Continuous data are analyzed using Pearson correlation analysis presented by correlation coefficient r and a p-value. Pearson correlation analysis is used to measure the strength of the linear relationship between normally distributed variables. A significance level of 5% is used. Binary values are assigned for data assessing secondary endpoints. Subsequently, a multiple linear regression analysis is performed to examine the influence of discrete variables on the primary endpoint. For statistical analysis and design of plots, the programs, R Studio (version 1.4.1106) and Excel (version 16.43) is used.

Registry
clinicaltrials.gov
Start Date
April 1, 2021
End Date
October 4, 2021
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Jens Rikardt Andersen
Responsible Party
Sponsor Investigator
Principal Investigator

Jens Rikardt Andersen

Assoc Prof

University of Copenhagen

Eligibility Criteria

Inclusion Criteria

  • Patients with haematological cancer
  • Patients receiving myelosuppressive chemotherapy for haematological disease
  • Adult patients

Exclusion Criteria

  • Patients who cannot understand and speak Danish or English
  • Pregnant and breastfeeding
  • Patients who suffer from dementia

Outcomes

Primary Outcomes

Loss of Lean Body Mass

Time Frame: 2 months

Lean Body Mass measured by bioimpedance

Study Sites (1)

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