NOURISH: Phase II Trial
| ISRCTN | ISRCTN39911673 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39911673 |
| Secondary identifying numbers | LU2005 |
- 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
Contact information
Dr Joyce Thompson
Scientific
Scientific
Department of Oncology
Heartlands Hospital
Bordesley Green East
Birmingham
B9 5SS
United Kingdom
Study information
| 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 |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 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(s) | The Black Country Research Ethics Committee Ref: 11/WM/0071 07 April 2011 |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Beta-hydroxy beta-methylbuyrate/arginine/glutamine (HMB/ARG/GLN) |
| Primary outcome measure | 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 study start date | 01/05/2011 |
| Overall study end date | 01/05/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 96 |
| 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 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
- England
- United Kingdom
Study participating centre
Department of Oncology
Birmingham
B9 5SS
United Kingdom
B9 5SS
United Kingdom
Sponsor information
University of Birmingham (UK)
University/education
University/education
Edgbaston
Birmingham
B15 2TT
England
United Kingdom
| Phone | +44 (0)121 414 3789 |
|---|---|
| NOURISH@trials.bham.ac.uk | |
"ROR" |
https://ror.org/03angcq70 |
Funders
Funder type
Research organisation
National Cancer Research Institute (NCRI)
No information available
Supportive and Palliative Care (SuPaC) Research Collaborative grant (LCSuPaC 30)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
