Malignant LymphomaNCT04698616
Lean Body Mass and Side Effects in Patients With Lymphoma
An observational study of Malignant Lymphoma, run by Jens Rikardt Andersen at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Lymphoma
- How many people
- 141 participants
- Where
- 2 sitesDenmark
- Study dates
- 9 Feb 2020to 3 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving myelosuppressive treatment for malignant lymphoma
Who may be able to join
- Patients receiving myelosuppressive treatment for malignant lymphoma assessed by the investigator.
- Legal of age
Who cannot join
- ECOG Performance Status ≥2
- People who cannot speak and understand Danish
- Pregnant and breastfeeding
- Dementia
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites, 1 recruiting
- Completed
University of Copenhagen
Copenhagen, Frederiksberg, 1958
- Recruiting
Sjællands Universitetshospital, Hæmatologisk Afdeling H60
Roskilde, 4000
Christian Bjørn Poulsen, MD,PhD, +45 47324809, cbpo@regionsjaelland.dk
Anna-Lisa Malene Glavind Egeberg, MSc
About this study
Official title: 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.
- Conditions
- Malignant Lymphoma
- Keywords
- lymphoma, body composition, lean body mass, chemotherapy, quality of life (QOL), nutritional status, physical activity
- Medical subject headings
- Lymphoma, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Lean Body Mass (LBM)
LBM measured by bioelectrical impedans corelated to the dosis of chemotherapeutics given
Measured: 8 weeks (two treatment cycles)
Secondary outcomes (4)
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
Measured: 8 weeks (two treatment cycles)
Quality of life (QOL) (score EORTC)
Correlation of score and difference in LBM (kg)
Measured: 8 weeks (two treatment cycles)
nutritional status at inclusion (NRS2002 - scale)
Predictive value of scale for ocurrence of side-effects (binary)
Measured: 8 weeks (two treatment cycles)
physical activity (scale - questionaire)
Corelation between cytostatic dose/kg LBM and scale
Measured: 8 weeks (two treatmenr cycles)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start9 Feb 2020
- Primary completion31 Jan 2021 (estimated)
- Study completion3 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 141 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jens Rikardt Andersen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jens Rikardt Andersen, University of Copenhagen
- Investigators
- Jens R Andersen, MD,MPA, Study chair, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04698616
- Sponsor's protocol ID
- SJ-823
- Status last verified
- Jan 2021
- First submitted
- 28 May 2020
- Last updated
- 7 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relation Between Lean Body Mass and Side Effects Induced by Chemotherapy in Patients With Lymphoma: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04698616
- Acronym / sponsor ID
- SJ-823
- Conditions
- Malignant Lymphoma
- Keywords
- lymphoma, body composition, lean body mass, chemotherapy, quality of life (QOL), nutritional status, physical activity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 141 participants (estimated)
- Lead sponsor
- Jens Rikardt AndersenUniversity, hospital or other
- Study start
- 9 Feb 2020 (actual)
- Primary completion
- 31 Jan 2021 (estimated)
- Study completion
- 3 Mar 2021 (estimated)
- First posted
- 7 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving myelosuppressive treatment for malignant lymphoma
Key inclusion criteria (2 listed)
- Patients receiving myelosuppressive treatment for malignant lymphoma assessed by the investigator.
- Legal of age
Key exclusion criteria (4 listed)
- ECOG Performance Status ≥2
- People who cannot speak and understand Danish
- Pregnant and breastfeeding
- Dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Lean Body Mass (LBM)
Time frame: 8 weeks (two treatment cycles)
LBM measured by bioelectrical impedans corelated to the dosis of chemotherapeutics given
4 secondary outcomes
Maximal tolerable dose of chemotherapeutics (microg/ml/kg LBM),
Time frame: 8 weeks (two treatment cycles)
Quality of life (QOL) (score EORTC)
Time frame: 8 weeks (two treatment cycles)
nutritional status at inclusion (NRS2002 - scale)
Time frame: 8 weeks (two treatment cycles)
physical activity (scale - questionaire)
Time frame: 8 weeks (two treatmenr cycles)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens R Andersen, MD,MPA study chair
University of Copenhagen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Lymphoma, run by Jens Rikardt Andersen at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian Bjørn Poulsen, MD, PhD (+45 47324809, cbpo@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lean Body Mass (LBM) (time frame: 8 weeks (two treatment cycles)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2021.