Nutritional Problems in Pallative Cancer

October 20, 2021 updated by: Jens Rikardt Andersen

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

44

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Sjælland
      • Hillerød, Sjælland, Denmark, 3400
        • Hillerod Hospital, Denmark

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Lung and pancreas cancer patients in chemotherapy.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
9-12 weeks (3 treatment cycles)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jens Rikardt Andersen

Collaborators

Hillerod Hospital, Denmark

Investigators

  • Principal Investigator: Maria Elisabeth Lendorf, MD, PhD, Hillerod Hospital, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2021

Primary Completion (Actual)

October 7, 2021

Study Completion (Actual)

October 7, 2021

Study Registration Dates

First Submitted

April 12, 2021

First Submitted That Met QC Criteria

April 12, 2021

First Posted (Actual)

April 15, 2021

Study Record Updates

Last Update Posted (Actual)

October 28, 2021

Last Update Submitted That Met QC Criteria

October 20, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-20083532

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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