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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04846985
Other study ID # H-20083532
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 26, 2021
Est. completion date October 7, 2021

Study information

Verified date October 2021
Source University of Copenhagen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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, food preferences, side effects, fatique and meal perception.


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.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date October 7, 2021
Est. primary completion date October 7, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Denmark Hillerod hospital, Denmark Hillerød Sjælland

Sponsors (2)

Lead Sponsor Collaborator
Jens Rikardt Andersen Hillerod Hospital, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 9-12 weeks (3 treatment cycles)
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