NOURISH: Phase II Trial

ISRCTN	ISRCTN39911673
DOI	https://doi.org/10.1186/ISRCTN39911673
Protocol serial number	LU2005
Sponsor	University of Birmingham (UK)
Funders	National Cancer Research Institute (NCRI), Supportive and Palliative Care (SuPaC) Research Collaborative grant (LCSuPaC 30)

Submission date: 14/04/2011
Registration date: 19/05/2011
Last edited: 12/06/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://cancerhelp.cancerresearchuk.org/trials/a-trial-see-taking-supplement-powder-helps-improve-weight-muscle-loss-people-lung-cancer-nourish

Contact information

Dr Joyce Thompson
Scientific

Department of Oncology
Heartlands Hospital
Bordesley Green East
Birmingham
B9 5SS
United Kingdom

Study information

Primary study design	Interventional
Study design	Prospective, multicentre, Phase II, two arm, double-blinded, placebo-controlled randomised clinical trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Improving the management of cachexia in patients with advanced lung cancer: does the introduction of beta-hydroxy beta-methylbutyrate / arginine / glutamine (HMB/ARG/GLN) supplementation maintain lean body mass and quality of life?
Study acronym	NOURISH
Study objectives	This is a phase II trial. The outcome will not, in itself, be interpreted to guide clinical management. The intention is to detect a signal that intervention using HMB/ARG/GLN supplementation alters the rate of change in LBM (used as a more meaningful measurement of cachexia than weight) sufficiently to justify further investigation in a Phase III trial. Other outcomes attributable to cachexia such as loss of muscle strength and deterioration in functional status and QoL will be measured as secondary endpoints. A Phase III trial will formally test the hypothesis that the intervention results in clinical benefit.
Ethics approval(s)	The Black Country Research Ethics Committee Ref: 11/WM/0071 07 April 2011
Health condition(s) or problem(s) studied	Management of cachexia in advanced lung cancer
Intervention	Patients will receive either beta-hydroxy beta-methylbuyrate/arginine/glutamine (HMB/ARG/GLN) or a matched placebo as 1 sachet twice daily twice daily for 12 weeks
Intervention type	Drug
Phase	Phase II
Drug / device / biological / vaccine name(s)	Beta-hydroxy beta-methylbuyrate/arginine/glutamine (HMB/ARG/GLN)
Primary outcome measure(s)	The number of patients who are alive without significant loss of lean body mass (LBM) (i.e. not more than 5%)
Key secondary outcome measure(s)	1. Change in LBM measured by Bioelectrical Impedance Analysis (BIA) after 12 weeks of HMB/ARG/GLN or a matched placebo compared to baseline 2. Lean body mass (LBM) at 3 weekly intervals from start of HMB/ARG/GLN/placebo intervention for 12 weeks 3. Functional status will be assessed by handgrip strength measured at each trial visit using the Jamer™ dynamometer 4. Change in QoL measured by the FAACT questionnaire from baseline to week 12
Completion date	01/05/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	96
Key inclusion criteria	1. Newly diagnosed small cell lung cancer (SCLC) or non small cell lung cancer (NSCLC) 2. Able to take oral nutrition 3. WHO performance status 0-2 4. Life expectancy greater than 4 months
Key exclusion criteria	1. Patients suitable for radical treatment with curative intent 2. Patients who have already commenced first line chemotherapy or radiotherapy 3. Patients for whom the diagnosis of lung cancer was made more than 8 weeks before trial entry 4. Known or suspected to be pregnant 5. Patients with pacemaker or internal defibrillator in situ
Date of first enrolment	01/05/2011
Date of final enrolment	01/05/2013

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Department of Oncology

Birmingham
B9 5SS
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Abstract results	abstract e20684	01/07/2014		No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes