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NCT04698616 Clinical Trial

Lean Body Mass and Side Effects in Patients With Lymphoma

Malignant Lymphoma Clinical Trial

Official title:
The Relation Between Lean Body Mass and Side Effects Induced by Chemotherapy in Patients With Lymphoma: A Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04698616
Other study ID # SJ-823
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 9, 2020
Est. completion date March 3, 2021

Study information
Verified date January 2021
Source University of Copenhagen
Contact Christian Bjørn Poulsen, MD, PhD
Phone +45 47324809
Email cbpo@regionsjaelland.dk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The primary purpose is to investigate the relationship between the dose of chemotherapeutic agents per kilogram of lean body mass (LBM) and the development of side effects induced by chemotherapy in patients with lymphoma. Secondarily, the maximum tolerable dose of chemotherapeutics (MTD), patients' quality of life (QOL), nutritional status and physical activity during the course of treatment are estimated.

Recruitment information / eligibility
Status Recruiting
Enrollment 141
Est. completion date March 3, 2021
Est. primary completion date January 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients receiving myelosuppressive treatment for malignant lymphoma assessed by the investigator. - Legal of age Exclusion Criteria: - ECOG Performance Status =2 - People who cannot speak and understand Danish - Pregnant and breastfeeding - Dementia

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Denmark University of Copenhagen Copenhagen Frederiksberg
Denmark Sjællands Universitetshospital, Hæmatologisk Afdeling H60 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 Lean Body Mass (LBM) LBM measured by bioelectrical impedans corelated to the dosis of chemotherapeutics given 8 weeks (two treatment cycles)
Secondary Maximal tolerable dose of chemotherapeutics (microg/ml/kg LBM), Patients with side effects - correlation between dose of cytostatics/ kg LBM compared to patients without side effects 8 weeks (two treatment cycles)
Secondary Quality of life (QOL) (score EORTC) Correlation of score and difference in LBM (kg) 8 weeks (two treatment cycles)
Secondary nutritional status at inclusion (NRS2002 - scale) Predictive value of scale for ocurrence of side-effects (binary) 8 weeks (two treatment cycles)
Secondary physical activity (scale - questionaire) Corelation between cytostatic dose/kg LBM and scale 8 weeks (two treatmenr cycles)
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