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
| 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 |
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.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| Denmark | University of Copenhagen | Copenhagen | Frederiksberg |
| Denmark | Sjællands Universitetshospital, Hæmatologisk Afdeling H60 | Roskilde |
| Lead Sponsor | Collaborator |
|---|---|
| Jens Rikardt Andersen |
Denmark,
| 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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