NCT04846985

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 15, 2021

Completed
11 days until next milestone

Study Start

First participant enrolled

April 26, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 7, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2021

Completed
Last Updated

October 28, 2021

Status Verified

October 1, 2021

Enrollment Period

5 months

First QC Date

April 12, 2021

Last Update Submit

October 20, 2021

Conditions

Keywords

Malnutritioncancerweight losslean body mass

Outcome Measures

Primary Outcomes (1)

  • 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)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Lung and pancreas cancer patients in chemotherapy.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillerod hospital, Denmark

Hillerød, Region Sjælland, 3400, Denmark

Location

MeSH Terms

Conditions

Lung NeoplasmsPancreatic NeoplasmsMalnutritionNeoplasmsWeight Loss

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract DiseasesDigestive System NeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesNutrition DisordersNutritional and Metabolic DiseasesBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Maria Elisabeth Lendorf, MD, PhD

    Hillerod Hospital, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor, Primary Investigator

Study Record Dates

First Submitted

April 12, 2021

First Posted

April 15, 2021

Study Start

April 26, 2021

Primary Completion

October 7, 2021

Study Completion

October 7, 2021

Last Updated

October 28, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations