Nutrifriend in Patients with (NSCLC) with Involuntary Weight Loss
Research type
Research Study
Full title
Randomised Pilot Study Assessing Saftey and Tolerability of Nutrifriend Cachexia in Patients Diagnosed with Non-Small Cell Lung Cancer with involuntary Weight Loss
IRAS ID
188370
Contact name
Maria Öhlander
Contact email
Sponsor organisation
Smartfish AB
Duration of Study in the UK
0 years, 4 months, 24 days
Research summary
The objectives of this study are to assess the safety and tolerability of Nutrifriend Cachexia (NFCax) as add-on nutritional treatment to chemotherapy in patients with non-small cell lung cancer (NSCLC) and involuntary weight loss.
Patients newly diagnosed with NSCLC stage I-IV (first-line treatment) and patients with a previous diagnosis of NSCLC but without a relapse in the previous 2 years who meet all of the inclusion criteria and none of the exclusion criteria will be invited to take part in the study.
Patients will be randomised to receive either NFCax or an isocaloric milk-based placebo drink not supplemented with vitamin D and where the omega-3 fatty acid has been replaced with sunflower oil. A minimum of 50 NSCLC patients (25 patients in the NFCax arm and 25 patients in the placebo arm) will complete at least 6 weeks of study treatment.
Two 200 mL packages containing either NFCax or placebo drink will be taken daily during the 12 week treatment period. A follow-up telephone call will be made 12 months after the start of study treatment to collect information about overall survival. The study will be conducted in the Sweden, Italy and the UK in which there is one site planned for the UK.
REC name
Wales REC 7
REC reference
15/WA/0352
Date of REC Opinion
30 Sep 2015
REC opinion
Unfavourable Opinion