Lean Body Mass and Side Effects in Patients With Lymphoma

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

Sponsors

Lead Sponsor: Jens Rikardt Andersen

Source University of Copenhagen
Brief 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.

Overall Status Recruiting
Start Date February 9, 2020
Completion Date March 3, 2021
Primary Completion Date January 31, 2021
Study Type Observational
Primary Outcome
Measure Time Frame
Lean Body Mass (LBM) 8 weeks (two treatment cycles)
Secondary Outcome
Measure Time Frame
Maximal tolerable dose of chemotherapeutics (microg/ml/kg LBM), 8 weeks (two treatment cycles)
Quality of life (QOL) (score EORTC) 8 weeks (two treatment cycles)
nutritional status at inclusion (NRS2002 - scale) 8 weeks (two treatment cycles)
physical activity (scale - questionaire) 8 weeks (two treatmenr cycles)
Enrollment 141
Condition
Eligibility

Sampling Method: Probability Sample

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Jens R Andersen, MD,MPA Study Chair University of Copenhagen
Overall Contact

Last Name: Christian Bjørn Poulsen, MD, PhD

Phone: +45 47324809

Email: [email protected]

Location
Facility: Status:
University of Copenhagen | Copenhagen, Frederiksberg, 1958, Denmark Completed
Sjællands Universitetshospital, Hæmatologisk Afdeling H60 | Roskilde, 4000, Denmark Recruiting Christian Bjørn Poulsen, MD,PhD +45 47324809 [email protected] Anna-Lisa Malene Glavind Egeberg, MSc Sub-Investigator Stine Kjørup Andersen, MSc Sub-Investigator
Location Countries

Denmark

Verification Date

January 2021

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: University of Copenhagen

Investigator Full Name: Jens Rikardt Andersen

Investigator Title: Sponsor - Investigator

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: Malignant lymphoma patients

Description: Identification of the patients who are/are not dose-reduced due to chemotherapy, and then look at the body composition in connection with this.

Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov