Condition category
Musculoskeletal Diseases
Date applied
14/04/2011
Date assigned
19/05/2011
Last edited
12/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Joyce Thompson

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

LU2005

Study information

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?

Acronym

NOURISH

Study hypothesis

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

The Black Country Research Ethics Committee Ref: 11/WM/0071 07 April 2011

Study design

Prospective, multicentre, Phase II, two arm, double-blinded, placebo-controlled randomised clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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 names

Beta-hydroxy beta-methylbuyrate/arginine/glutamine (HMB/ARG/GLN)

Primary outcome measures

The number of patients who are alive without significant loss of lean body mass (LBM) (i.e. not more than 5%)

Secondary outcome measures

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

Overall trial start date

01/05/2011

Overall trial end date

01/05/2013

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

96

Participant 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

Recruitment start date

01/05/2011

Recruitment end date

01/05/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Oncology
Birmingham
B9 5SS
United Kingdom

Sponsor information

Organisation

University of Birmingham (UK)

Sponsor details

Edgbaston
Birmingham
B15 2TT
United Kingdom
+44 (0)121 414 3789
NOURISH@trials.bham.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

National Cancer Research Institute (NCRI)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Supportive and Palliative Care (SuPaC) Research Collaborative grant (LCSuPaC 30)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in:
Effect of beta-hydroxy beta-methylbutyrate/arginine/glutamine (HMB/Arg/Gln) on lean body mass (LBM), in patients with advanced lung cancer.
Journal of Clinical Oncology, 2014 ASCO Annual Meeting Abstracts.
Vol 32, No 15_suppl (May 20 Supplement), 2014: e20684

Publication citations

Additional files

Editorial Notes