MalnutritionNCT05209321
Predictors of Malnutrition in Patients With Haematological Cancer
An observational study of Malnutrition and Lymphoma, run by Jens Rikardt Andersen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition, Lymphoma
- How many people
- 62 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2021to 4 Oct 2021
- How long will I take part?
- 2 Months
- 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 over the age of 18 years, with haematological cancer, receiving myelosuppressive chemotherapy.
Who may be able to join
- Patients with haematological cancer
- Patients receiving myelosuppressive chemotherapy for haematological disease
- Adult patients
Who cannot join
- Patients who cannot understand and speak Danish or English
- Pregnant and breastfeeding
- Patients who suffer from dementia
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
It was assessed by the National Ethics Committee that the experiment was not subject to notification, cf. section 14 (1) of the Committee Act. 2. The project has been approved by the Ethical Research Committee for SUND and SCIENCE, University of Copenhagen.. The project was also approved by the Danish Data Protection Agency at Region Zealand with case no .: REG-166-2020. A data processor agreement was established between Region Zealand and thesis students.
Data is presented as mean +/- SD. Continuous data are analyzed using Pearson correlation analysis presented by correlation coefficient r and a p-value. Pearson correlation analysis is used to measure the strength of the linear relationship between normally distributed variables. A significance level of 5% is used.
Binary values are assigned for data assessing secondary endpoints. Subsequently, a multiple linear regression analysis is performed to examine the influence of discrete variables on the primary endpoint.
For statistical analysis and design of plots, the programs, R Studio (version 1.4.1106) and Excel (version 16.43) is used.
- Conditions
- Malnutrition, Lymphoma
- Medical subject headings
- Malnutrition, Lymphoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Loss of Lean Body Mass
Lean Body Mass measured by bioimpedance
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start1 Apr 2021
- Primary completion15 Jul 2021
- Study completion4 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies 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
- 62 participants (actual)
- Target duration
- 2 Months
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 director, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05209321
- Sponsor's protocol ID
- 504-0226
- Status last verified
- Nov 2022
- First submitted
- 12 Jan 2022
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Malnutrition in Patients With Haematological Cancer
- ClinicalTrials.gov ID
- NCT05209321
- Acronym / sponsor ID
- 504-0226
- Conditions
- Malnutrition, Lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Jens Rikardt AndersenUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 4 Oct 2021 (actual)
- First posted
- 26 Jan 2022 (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 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.
Detailed description
It was assessed by the National Ethics Committee that the experiment was not subject to notification, cf. section 14 (1) of the Committee Act. 2. The project has been approved by the Ethical Research Committee for SUND and SCIENCE, University of Copenhagen.. The project was also approved by the Danish Data Protection Agency at Region Zealand with case no .: REG-166-2020. A data processor agreement was established between Region Zealand and thesis students.
Data is presented as mean +/- SD. Continuous data are analyzed using Pearson correlation analysis presented by correlation coefficient r and a p-value. Pearson correlation analysis is used to measure the strength of the linear relationship between normally distributed variables. A significance level of 5% is used.
Binary values are assigned for data assessing secondary endpoints. Subsequently, a multiple linear regression analysis is performed to examine the influence of discrete variables on the primary endpoint.
For statistical analysis and design of plots, the programs, R Studio (version 1.4.1106) and Excel (version 16.43) is used.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over the age of 18 years, with haematological cancer, receiving myelosuppressive chemotherapy.
Key inclusion criteria (3 listed)
- Patients with haematological cancer
- Patients receiving myelosuppressive chemotherapy for haematological disease
- Adult patients
Key exclusion criteria (3 listed)
- Patients who cannot understand and speak Danish or English
- Pregnant and breastfeeding
- Patients who suffer from 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
Loss of Lean Body Mass
Time frame: 2 months
Lean Body Mass measured by bioimpedance
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Individual participant dataSharing planned: Undecided
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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 director
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition and Lymphoma, run by Jens Rikardt Andersen at 1 site 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Loss of Lean Body Mass (time frame: 2 months). 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 4 Nov 2022.