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NOURISH: Phase II Trial

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?

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN39911673
Enrollment
96
Registered
2011-05-19
Start date
2011-05-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Management of cachexia in advanced lung cancer Musculoskeletal Diseases Cachexia

Interventions

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

Sponsors

University of Birmingham (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 22, 2026