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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04698616

Enrollment

141

Registered

2021-01-07

Start date

2020-02-09

Completion date

2021-03-03

Last updated

2021-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Lymphoma

Keywords

lymphoma, body composition, lean body mass, chemotherapy, quality of life (QOL), nutritional status, physical activity

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Lean Body Mass (LBM)	8 weeks (two treatment cycles)	LBM measured by bioelectrical impedans corelated to the dosis of chemotherapeutics given

Secondary

Measure	Time frame	Description
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
Quality of life (QOL) (score EORTC)	8 weeks (two treatment cycles)	Correlation of score and difference in LBM (kg)
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

Countries

Denmark

Contacts

Primary ContactChristian Bjørn Poulsen, MD, PhD

cbpo@regionsjaelland.dk+45 47324809

Backup ContactJens R Andersen, MD,MPA

jra@post3.tele.dk+4523346654

Outcome results