Predictors of Malnutrition in Patients With Haematological Cancer

Lymphoma Clinical Trial

Official title:

Predictors of Malnutrition in Patients With Haematological Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05209321
• Other study ID #: 504-0226
• Status: Completed
• Start date: April 1, 2021
• Est. completion date: October 4, 2021

Study information

• Verified date: November 2022
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: October 4, 2021
• Est. primary completion date: July 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Malnutrition

Locations

Country	Name	City	State
Denmark	Dept Haematology, Roskilde University Hospital	Roskilde

Sponsors (1)

Lead Sponsor	Collaborator
Jens Rikardt Andersen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Loss of Lean Body Mass	Lean Body Mass measured by bioimpedance	2 months