Lean Body Mass and Side Effects in Patients With Lymphoma
- Conditions
- Malignant Lymphoma
- Registration Number
- NCT04698616
- Lead Sponsor
- Jens Rikardt Andersen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 141
- Patients receiving myelosuppressive treatment for malignant lymphoma assessed by the investigator.
- Legal of age
- ECOG Performance Status ≥2
- People who cannot speak and understand Danish
- Pregnant and breastfeeding
- Dementia
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Lean Body Mass (LBM) 8 weeks (two treatment cycles) LBM measured by bioelectrical impedans corelated to the dosis of chemotherapeutics given
- Secondary Outcome Measures
Name Time Method Maximal tolerable dose of chemotherapeutics (microg/ml/kg LBM), 8 weeks (two treatment cycles) Patients with side effects - correlation between dose of cytostatics/ kg LBM compared to patients without side effects
nutritional status at inclusion (NRS2002 - scale) 8 weeks (two treatment cycles) Predictive value of scale for ocurrence of side-effects (binary)
physical activity (scale - questionaire) 8 weeks (two treatmenr cycles) Corelation between cytostatic dose/kg LBM and scale
Quality of life (QOL) (score EORTC) 8 weeks (two treatment cycles) Correlation of score and difference in LBM (kg)
Trial Locations
- Locations (2)
Sjællands Universitetshospital, Hæmatologisk Afdeling H60
🇩🇰Roskilde, Denmark
University of Copenhagen
🇩🇰Copenhagen, Frederiksberg, Denmark