Predictors of Malnutrition in Patients With Haematological Cancer

NCT ID: NCT05209321

Last Updated: 2022-11-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 62 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2021-10-04

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.

Conditions

Malnutrition; Lymphoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jens Rikardt Andersen

OTHER

Sponsor Role: lead

Responsible Party

Jens Rikardt Andersen

Assoc Prof

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jens R Andersen, MD,MPA

Role: STUDY_DIRECTOR

University of Copenhagen

Locations

Dept Haematology, Roskilde University Hospital

Roskilde, , Denmark

Countries

Denmark

Other Identifiers

504-0226

Identifier Type: -

Identifier Source: org_study_id