Muscle Dysfunction in Patients With Haematological Diseases

August 12, 2026 updated by: Jan Christensen, Rigshospitalet, Denmark

The Prevalence and the Prognostic Value of Sarcopenia Among Patients With Haematological Cancer Diseases - A Prospective Observational Cohort Study.

PURPOSE: To evaluate the prevalence and prognostic value of sarcopenia in patients diagnosed with hematological cancer diseases.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Some patients diagnosed with malignant hematological diseases are faced with poor prognosis and thus must undergo a demanding course of treatment associated with severe deconditioning potentially leading to worse prognostic outcomes. It is currently not well-described, to what extend patients body composition at the point of diagnoses should be part of standard clinical evaluation in order to optimize therapy-efficacy. Recent findings suggest that pathophysiological alterations in skeletal muscle mass and function can have significant implications for the risk of disease progression and long-term prognosis.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
216

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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Rigshospitalet

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with malignant lymphomas, acute leukaemia and multiple myeloma referred to treatment.

Description

Inclusion Criteria:

• Patients diagnosed with malignant lymphomas, acute leukaemia and multiple myeloma referred to treatment at the Department of Haematology, Rigshospitalet.

Exclusion Criteria:

  • Age: <18
  • Pregnancy
  • Physical or mental disabilities precluding test of muscle function
  • Inability to read and understand Danish.

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Cohort I - Patients newly diagnosed with malignant lymphoma (n=72)
These patients will undergo two assessments: A baseline-assessment prior to treatment for the hematologic cancer disease and a follow-up assessment at 6 months after treatment start
Cohort II - Patients newly diagnosed with acute leukaemia (n=72)
These patients will undergo two assessments: A baseline-assessment prior to treatment for the hematologic cancer disease and a follow-up assessment at 6 months after treatment start
Cohort III - Patients newly diagnosed with multiple myeloma (n=72)
These patients will undergo two assessments: A baseline-assessment prior to treatment for the hematologic cancer disease and a follow-up assessment at 6 months after treatment start

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Whole body Lean body Mass
Time Frame: Baseline and 6 months after treatment start
Dual-energy X-ray Absorptiometry (DXA) scan
Baseline and 6 months after treatment start

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hospitalization duration
Time Frame: 1 year post treatment
Total number days in hospital
1 year post treatment
Disease free survival
Time Frame: 1 year post treatment
Risk of disease progression
1 year post treatment
Overall survival
Time Frame: 1 year post treatment
Risk of mortality from any-cause
1 year post treatment
Change in appendicular lean mass
Time Frame: Baseline and 6 after treatment start
Dual-energy X-ray Absorptiometry (DXA) scan
Baseline and 6 after treatment start
Change in whole body fat percentage
Time Frame: Baseline and 6 months after treatment start
Dual-energy X-ray Absorptiometry (DXA) scan
Baseline and 6 months after treatment start
Change in visceral fat mass
Time Frame: Baseline and 6 months after treatment start
Dual-energy X-ray Absorptiometry (DXA) scan
Baseline and 6 months after treatment start
Change in bone mineral density
Time Frame: Baseline and 6 months after treatment start
Dual-energy X-ray Absorptiometry (DXA) scan
Baseline and 6 months after treatment start
Change in bone mineral content
Time Frame: Baseline and 6 months after treatment start
Dual-energy X-ray Absorptiometry (DXA) scan
Baseline and 6 months after treatment start
Change in walking capacity
Time Frame: Baseline and 6 months after treatment start
Maximum 10 meter walking speed
Baseline and 6 months after treatment start
Change in lower body physical function
Time Frame: Baseline and 6 months after treatment start
30 seconds Sit-To-Stand test
Baseline and 6 months after treatment start
Change in maximum leg power
Time Frame: Baseline and 6 months after treatment start
Leg extensor power test (Nottingham Power Rig)
Baseline and 6 months after treatment start
Change in hand grip strength
Time Frame: Baseline and 6 months after treatment start
Maximum strength test by handgrip dynamometer
Baseline and 6 months after treatment start
Change in inflammation markers
Time Frame: Baseline and 6 months after treatment start
Blood values are registered from the patients hospital record in relation to assessments. C-reactive protein (CRP) and leucocytes are registered as they are inflammation markers.
Baseline and 6 months after treatment start
Change in creatinine
Time Frame: Baseline and 6 months after treatment start
Blood values are registered from the patients hospital record in relation to assessments. Creatinine is registered due to their relation to muscle strength..
Baseline and 6 months after treatment start
Change in hemoglobin
Time Frame: Baseline and 6 months after treatment start
Blood values are registered from the patients hospital record in relation to assessments. Hemoglobin is registered due to their relation to muscle strength.
Baseline and 6 months after treatment start
Change in body fat percentage
Time Frame: Baseline and 6 months after treatment start
Bioelectrical Impedance Analyzer
Baseline and 6 months after treatment start
Change in fat mass
Time Frame: Baseline and 6 months after treatment start
Bioelectrical Impedance Analyzer
Baseline and 6 months after treatment start
Change in fat-free mass
Time Frame: Baseline and 6 months after treatment start
Bioelectrical Impedance Analyzer
Baseline and 6 months after treatment start
Change in muscle mass
Time Frame: Baseline and 6 months after treatment start
Bioelectrical Impedance Analyzer
Baseline and 6 months after treatment start
Change in bone mass
Time Frame: Baseline and 6 months after treatment start
Bioelectrical Impedance Analyzer
Baseline and 6 months after treatment start
Change in total body water
Time Frame: Baseline and 6 months after treatment start
Bioelectrical Impedance Analyzer
Baseline and 6 months after treatment start
Change in health-related quality of life
Time Frame: Baseline and 6 months after treatment start
European Organisation for Research and Treatment of Cancer Quality of LifeQuestionnaire, Version 3.0 Scores range from 0 to 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.
Baseline and 6 months after treatment start
Change in physical activity level
Time Frame: Baseline and 6 months after treatment start
The International Physical Activity Questionnaires, short form. The Questionnaires covers the frequency and duration of vigorous, moderate, and walking activities over the last 7 days, as well as a single-item question on weekday sitting. Using the instrument's scoring protocol, total weekly physical activity can be calculated to three levels of physical activity and the interpretation of the questionnaire can be categorized in low, moderate and high physical activity, based on the stated time and Metabolic Equivalent of Task (METs min/week) used in different types of activities.
Baseline and 6 months after treatment start

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rigshospitalet, Denmark

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 8, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 9, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MuscleLab2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Not provided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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