Lung CancerNCT04846985
Nutritional Problems in Pallative Cancer
An observational study of Lung Cancer and Pancreatic Cancer, run by Jens Rikardt Andersen at 1 site in Denmark.
Trial summary
The aim of this study is to investigate those nutritional problems contributing to loss of lean body mass in lung and pancreas cancer patients in chemotherapy. Furthermore to investigate alterations in taste and how they correlates with changes in following factors: nutritional intake, physical activity, appetite… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Pancreatic Cancer
- How many people
- 44 participants
- Where
- 1 siteDenmark
- Study dates
- 26 Apr 2021to 7 Oct 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: Lung and pancreas cancer patients in chemotherapy.
Who may be able to join
- Lung or pancreas cancer patient
- In chemoterapy regardless of line treatment with/without combined treatment
- Legal age
- Able to speak and read in danish
- Ambulant
Who cannot join
- Inability to give consent and complete questionnaires
- Participating in clinical interventions during the periode of observation
- Allergic to milk or for any reason don't consume diary products
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study of Nutritional Problems in Lung and Pancreas Cancer Patients in Chemotherapy
The aim of this study is to investigate those nutritional problems contributing to loss of lean body mass in lung and pancreas cancer patients in chemotherapy. Furthermore to investigate alterations in taste and how they correlates with changes in following factors: nutritional intake, physical activity, appetite, food preferences, side effects, fatique and meal perception.
Read the detailed description
This study will include a recruitment of 50 lung and pancreas cancer patients currently in chemotherapy. They will be observed during a period of 9-12 week, including at least 2 chemotherapy treatments. The presence and severity of the nutritional problems will be examined by observing as many different factors as possible. This includes taste alterations, weight changes, nutritional intake, physical activity, interviews and weekly questionnaires. In relation to this our primary outcome is to investigate the correlation between changes in taste and changes in nutritional intake. Secondarily the investigators want to investigate nutritional intake, physical activity, appetite, food preferences, side effects, fatique and meal perception.
- Conditions
- Lung Cancer, Pancreatic Cancer
- Keywords
- Malnutrition, cancer, weight loss, lean body mass
- Medical subject headings
- Lung Neoplasms, Pancreatic Neoplasms, Malnutrition, Neoplasms, Weight Loss
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the correlation between changes in taste and changes in nutritional intake
Changes in taste measured by a sensory test combined with questionnaires, and changes in nutrional intake is measured by photografies of meals
Measured: 9-12 weeks (3 treatment cycles)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start26 Apr 2021
- Primary completion7 Oct 2021
- Study completion7 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jens Rikardt Andersen
- Sponsor type
- University, hospital or other
- Collaborators
- Hillerod Hospital, Denmark
- Responsible party
- Sponsor-investigator, Jens Rikardt Andersen, University of Copenhagen
- Investigators
- Maria Elisabeth Lendorf, MD, PhD, Principal investigator, Hillerod Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04846985
- Sponsor's protocol ID
- H-20083532
- Status last verified
- Oct 2021
- First submitted
- 12 Apr 2021
- Last updated
- 28 Oct 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 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Nutritional Problems in Lung and Pancreas Cancer Patients in Chemotherapy
- ClinicalTrials.gov ID
- NCT04846985
- Acronym / sponsor ID
- H-20083532
- Conditions
- Lung Cancer, Pancreatic Cancer
- Keywords
- Malnutrition, cancer, weight loss, lean body mass
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Jens Rikardt AndersenUniversity, hospital or other
- Collaborators
- Hillerod Hospital, Denmark
- Study start
- 26 Apr 2021 (actual)
- Primary completion
- 7 Oct 2021 (actual)
- Study completion
- 7 Oct 2021 (actual)
- First posted
- 15 Apr 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 aim of this study is to investigate those nutritional problems contributing to loss of lean body mass in lung and pancreas cancer patients in chemotherapy. Furthermore to investigate alterations in taste and how they correlates with changes in following factors: nutritional intake, physical activity, appetite, food preferences, side effects, fatique and meal perception.
Detailed description
This study will include a recruitment of 50 lung and pancreas cancer patients currently in chemotherapy. They will be observed during a period of 9-12 week, including at least 2 chemotherapy treatments. The presence and severity of the nutritional problems will be examined by observing as many different factors as possible. This includes taste alterations, weight changes, nutritional intake, physical activity, interviews and weekly questionnaires. In relation to this our primary outcome is to investigate the correlation between changes in taste and changes in nutritional intake. Secondarily the investigators want to investigate nutritional intake, physical activity, appetite, food preferences, side effects, fatique and meal perception.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lung and pancreas cancer patients in chemotherapy.
Key inclusion criteria (5 listed)
- Lung or pancreas cancer patient
- In chemoterapy regardless of line treatment with/without combined treatment
- Legal age
- Able to speak and read in danish
- Ambulant
Key exclusion criteria (3 listed)
- Inability to give consent and complete questionnaires
- Participating in clinical interventions during the periode of observation
- Allergic to milk or for any reason don't consume diary products
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
To investigate the correlation between changes in taste and changes in nutritional intake
Time frame: 9-12 weeks (3 treatment cycles)
Changes in taste measured by a sensory test combined with questionnaires, and changes in nutrional intake is measured by photografies of meals
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 28 Oct 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.
Maria Elisabeth Lendorf, MD, PhD principal investigator
Hillerod Hospital, Denmark
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 Lung Cancer and Pancreatic Cancer, 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 5 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 28 Oct 2021. 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?
To investigate the correlation between changes in taste and changes in nutritional intake (time frame: 9-12 weeks (3 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 28 Oct 2021.