Lean Body Mass and Side Effects in Patients With Lymphoma

January 4, 2021 updated by: Jens Rikardt Andersen

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

141

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
      • Roskilde, Denmark, 4000
        • Recruiting
        • Sjællands Universitetshospital, Hæmatologisk Afdeling H60
        • Contact:
        • Sub-Investigator:
          • Anna-Lisa Malene Glavind Egeberg, MSc
        • Sub-Investigator:
          • Stine Kjørup Andersen, MSc
    • Frederiksberg
      • Copenhagen, Frederiksberg, Denmark, 1958
        • Completed
        • University of Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients receiving myelosuppressive treatment for malignant lymphoma

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximal tolerable dose of chemotherapeutics (microg/ml/kg LBM),
Time Frame: 8 weeks (two treatment cycles)
Patients with side effects - correlation between dose of cytostatics/ kg LBM compared to patients without side effects
8 weeks (two treatment cycles)
Quality of life (QOL) (score EORTC)
Time Frame: 8 weeks (two treatment cycles)
Correlation of score and difference in LBM (kg)
8 weeks (two treatment cycles)
nutritional status at inclusion (NRS2002 - scale)
Time Frame: 8 weeks (two treatment cycles)
Predictive value of scale for ocurrence of side-effects (binary)
8 weeks (two treatment cycles)
physical activity (scale - questionaire)
Time Frame: 8 weeks (two treatmenr cycles)
Corelation between cytostatic dose/kg LBM and scale
8 weeks (two treatmenr cycles)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jens Rikardt Andersen

Investigators

  • Study Chair: Jens R Andersen, MD,MPA, University of Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2020

Primary Completion (Anticipated)

January 31, 2021

Study Completion (Anticipated)

March 3, 2021

Study Registration Dates

First Submitted

May 28, 2020

First Submitted That Met QC Criteria

January 4, 2021

First Posted (Actual)

January 7, 2021

Study Record Updates

Last Update Posted (Actual)

January 7, 2021

Last Update Submitted That Met QC Criteria

January 4, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SJ-823

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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