few studies have investigated the effect of nutritional counselling on
quality of life (QoL) in cancer patients after discharge (Ovesen et al.
1993, Persson et al. 2002, Isenring et al. 2004, Ravasco et al. 2005a,
Ravasco et al. 2005b). However, there is to our knowledge not conducted
any studies examining the effect of home delivered meals on QoL and
other endpoints in outpatients suffering from cancer.
The overall objective of the study is to measure the effect of
energy- and protein enriched home delivered meals vs. habitual diet in
malnourished outpatients diagnosed with lung cancer. The study is
designed as a 12-week randomized controlled intervention study. The
study sample will consist of 40 outpatients at nutritional risk, under
treatment for lung cancer at Copenhagen University Hospital Herlev,
Denmark. To be included in the study, participants must have a
nutritional risk score ≥ 3 according to NRS-2002 (Kondrup J. et al.
2003) and have a life expectancy > 12 weeks, among others.
The primary endpoint is the change in QoL from enrolment to the
study. Secondary endpoints include CES-D depression score, ECOG
performance status, weight change, handgrip strength, chair-stand test
and estimated energy- and protein intake. Endpoints are assessed at
baseline and after 6 and 12 weeks. Furthermore, the number of unplanned
re-admissions to the hospital and mortality are investigated during the
intervention period and 6 months post-intervention.
The intervention diet will consist of optional protein- and
energy-dense main and in-between-meals. There will be 22 different main
meals and 13 in-between meals to choose between. The meals are prepared
by The Nordic Kitchen of Copenhagen University Hospital Herlev. The
offered main meals will consist of a selection of warm dishes taken from
the ordinary menu. The in-between meals are a collection of the
Delights of Herlev (dishes previously shown to increase dietary intake
among in-patients). The food will be delivered to the participants’ home
3 times per week, and participants can order one warm dish and ad
libitum in-between meals for each day.
The project is planned to run from March
to September 2014, and the study has received funding from Copenhagen
University Hospital Herlev and the Capital Region of Denmark.
Professor Arne Astrup is head of research in the RUMLE study. Eva Leedo is the Project Manager.
RUMLE is registered on
www.clinicaltrials.gov identified as NCT02093312, approved by the
Ethical Committee, journal number: H-4-2013-FSP and declared to the
Danish data protection agency.