OURISH: Phase II Trial
Completed
- Conditions
- Management of cachexia in advanced lung cancerMusculoskeletal DiseasesCachexia
- Registration Number
- ISRCTN39911673
- Lead Sponsor
- niversity of Birmingham (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 96
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The number of patients who are alive without significant loss of lean body mass (LBM) (i.e. not more than 5%)
- Secondary Outcome Measures
Name Time Method 1. Change in LBM measured by Bioelectrical Impedance Analysis (BIA) after 12 weeks of HMB/ARG/GLN or a matched placebo compared to baseline<br>2. Lean body mass (LBM) at 3 weekly intervals from start of HMB/ARG/GLN/placebo intervention for 12 weeks<br>3. Functional status will be assessed by handgrip strength measured at each trial visit using the Jamer™ dynamometer<br>4. Change in QoL measured by the FAACT questionnaire from baseline to week 12