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
1 other identifier
observational
141
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2020
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 9, 2020
CompletedFirst Submitted
Initial submission to the registry
May 28, 2020
CompletedFirst Posted
Study publicly available on registry
January 7, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 3, 2021
CompletedJanuary 7, 2021
January 1, 2021
12 months
May 28, 2020
January 4, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Lean Body Mass (LBM)
LBM measured by bioelectrical impedans corelated to the dosis of chemotherapeutics given
8 weeks (two treatment cycles)
Secondary Outcomes (4)
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)
Study Arms (1)
Malignant lymphoma patients
Identification of the patients who are/are not dose-reduced due to chemotherapy, and then look at the body composition in connection with this.
Eligibility Criteria
Patients receiving myelosuppressive treatment for malignant lymphoma
You may qualify if:
- Patients receiving myelosuppressive treatment for malignant lymphoma assessed by the investigator.
- Legal of age
You may not qualify if:
- ECOG Performance Status ≥2
- People who cannot speak and understand Danish
- Pregnant and breastfeeding
- Dementia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Copenhagen
Copenhagen, Frederiksberg, 1958, Denmark
Sjællands Universitetshospital, Hæmatologisk Afdeling H60
Roskilde, 4000, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jens R Andersen, MD,MPA
University of Copenhagen
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Sponsor - Investigator
Study Record Dates
First Submitted
May 28, 2020
First Posted
January 7, 2021
Study Start
February 9, 2020
Primary Completion
January 31, 2021
Study Completion
March 3, 2021
Last Updated
January 7, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share