NCT05209321

Brief Summary

The primary purpose of this study is to conduct an exploratory study of which predictors are most significant for LBM loss in patients with lymphoma. Patients are measured by weight and bio impedance and furthermore, their physical activity, nutritional status, diet and quality of life during the course are estimated. This is done in order to determine any changes in the aforementioned factors during the course of the cancer treatment that may have a bearing on the loss of LBM.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 26, 2022

Completed
Last Updated

November 4, 2022

Status Verified

November 1, 2022

Enrollment Period

4 months

First QC Date

January 12, 2022

Last Update Submit

November 2, 2022

Conditions

MalnutritionLymphoma

Outcome Measures

Primary Outcomes (1)

  • Loss of Lean Body Mass

    Lean Body Mass measured by bioimpedance

    2 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients over the age of 18 years, with haematological cancer, receiving myelosuppressive chemotherapy.

You may qualify if:

  • Patients with haematological cancer
  • Patients receiving myelosuppressive chemotherapy for haematological disease
  • Adult patients

You may not qualify if:

  • Patients who cannot understand and speak Danish or English
  • Pregnant and breastfeeding
  • Patients who suffer from dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept Haematology, Roskilde University Hospital

Roskilde, 4000, Denmark

Location

MeSH Terms

Conditions

MalnutritionLymphoma

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Jens R Andersen, MD,MPA

    University of Copenhagen

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assoc Prof

Study Record Dates

First Submitted

January 12, 2022

First Posted

January 26, 2022

Study Start

April 1, 2021

Primary Completion

July 15, 2021

Study Completion

October 4, 2021

Last Updated

November 4, 2022

Record last verified: 2022-11

Locations

DK(1)