NCT02093312

Brief Summary

The overall objective of the study is to investigate the effect of energy- and protein enriched home delivered meals vs. habitual diet in malnourished patients suffering from cancer on various endpoints.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable lung-cancer

Timeline
Completed

Started Mar 2014

Shorter than P25 for not_applicable lung-cancer

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

February 20, 2014

Completed
9 days until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 21, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

December 21, 2022

Status Verified

December 1, 2022

Enrollment Period

7 months

First QC Date

February 20, 2014

Last Update Submit

December 20, 2022

Conditions

Lung CancerAmbulantMalnourished

Keywords

CancerFood-deliveryNutritional InterventionQuality of lifeOutpatients

Outcome Measures

Primary Outcomes (2)

  • Quality of Life

    To assess the Global QoL, a questionnaire from the European Organization for the Research and Treatment of Cancer (EORTC) QLQ-30, version 3, will be used. This is a validated, cancer-specific questionnaire with a total of 30 questions, looking back at the past week. The scoring of QoL is based on 2 specific questions with response options ranging from 1-7 which indicate very bad to very good. A Danish version of the questionnaire will be used.

    6 weeks (change from baseline)

  • Quality of Life

    To assess the Global QoL, a questionnaire from the European Organization for the Research and Treatment of Cancer (EORTC) QLQ-30, version 3, will be used. This is a validated, cancer-specific questionnaire with a total of 30 questions, looking back at the past week. The scoring of QoL is based on 2 specific questions with response options ranging from 1-7 which indicate very bad to very good. A Danish version of the questionnaire will be used.

    12 weeks (change from baseline)

Secondary Outcomes (10)

  • Hand grip strength

    6, and 12 weeks (changes from baseline)

  • 30-second chair-stand test

    6, and 12 weeks (changes from baseline)

  • Body Weight

    6, and 12 weeks (changes from baseline)

  • Depression Scale

    6, and 12 weeks (changes from baseline)

  • Total energy- and protein intake per day

    6, and 12 weeks (changes from baseline)

  • +5 more secondary outcomes

Other Outcomes (16)

  • Compliance

    1, 6, and 12 weeks

  • Evaluation

    12 weeks

  • Effect of social status on total energy- and protein intake

    Baseline

  • +13 more other outcomes

Study Arms (2)

Control group

NO INTERVENTION

The control group is not offered any home food-delivery service, but continues with their habitual diet

Intervention group

EXPERIMENTAL

The intervention group is offered home food-delivery service

Dietary Supplement: Home food-delivery service

Interventions

Home food-delivery serviceDIETARY_SUPPLEMENT

A home food-delivery service is offered the intervention group of cancer patients

Intervention group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Have a nutritional risk score ≥ 3 according to NRS-2002 (Kondrup J. et al. 2003)
  • Be diagnosed with lung cancer
  • Have a life expectancy \> 12 weeks
  • Not plan to loose weight or go on a diet
  • Not plan to go on vacation for \> 2 weeks during the study period
  • Live at their own home
  • Live ≤ 25 km from the hospital
  • Be able to read, write and understand Danish

You may not qualify if:

  • Receives food from a food-delivery service
  • Have food allergies or intolerance
  • Exclusively receives enteral or parenteral nutrition
  • Suffers from cognitive impairment e.g. dementia
  • Is terminal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herlev University Hsopital

Herlev, 2730, Denmark

Location

Related Publications (1)

  • Leedo E, Gade J, Granov S, Mellemgaard A, Klausen TW, Rask K, Astrup A. The Effect of a Home Delivery Meal Service of Energy- and Protein-Rich Meals on Quality of Life in Malnourished Outpatients Suffering from Lung Cancer: A Randomized Controlled Trial. Nutr Cancer. 2017 Apr;69(3):444-453. doi: 10.1080/01635581.2017.1283421. Epub 2017 Feb 17.

    PMID: 28287324RESULT

MeSH Terms

Conditions

Lung NeoplasmsMalnutritionNeoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract DiseasesNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Arne V Astrup, Professor

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

  • Eva Leedo, Cand Scient

    University of Copenhagen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Reseach

Study Record Dates

First Submitted

February 20, 2014

First Posted

March 21, 2014

Study Start

March 1, 2014

Primary Completion

October 1, 2014

Study Completion

April 1, 2015

Last Updated

December 21, 2022

Record last verified: 2022-12

Locations

DK(1)