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Nutritional Problems in Pallative Cancer

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ClinicalTrials.gov Identifier: NCT04846985
Recruitment Status : Not yet recruiting
First Posted : April 15, 2021
Last Update Posted : April 15, 2021
Sponsor:
Collaborator:
Hillerød hospital, Denmark
Information provided by (Responsible Party):
Jens Rikardt Andersen, University of Copenhagen

Brief 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.

Condition or disease
Lung Cancer Pancreatic Cancer

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 we want to investigate nutritional intake, physical activity, appetite, food preferences, side effects, fatique and meal perception.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Observational Study of Nutritional Problems in Lung and Pancreas Cancer Patients in Chemotherapy
Estimated Study Start Date : April 26, 2021
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nutrition




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Lung and pancreas cancer patients in chemotherapy.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04846985


Contacts
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Contact: Maria Elisabeth Lendorf, MD, PhD +4548293026 maria.elisabeth.lendorf.02@regionh.dk
Contact: Jens Rikardt Andersen, MD, MPA +4523346654 jra@nexs.ku.dk

Sponsors and Collaborators
Jens Rikardt Andersen
Hillerød hospital, Denmark
Investigators
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Principal Investigator: Maria Elisabeth Lendorf, MD, PhD Hillerod Hospital, Denmark
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Responsible Party: Jens Rikardt Andersen, Associate Professor, Primary Investigator, University of Copenhagen
ClinicalTrials.gov Identifier: NCT04846985    
Other Study ID Numbers: H-20083532
First Posted: April 15, 2021    Key Record Dates
Last Update Posted: April 15, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jens Rikardt Andersen, University of Copenhagen:
Malnutrition
cancer
weight loss
lean body mass
Additional relevant MeSH terms:
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Nutrition Disorders