Pilot Study of Safety and Tolerability of Nutrifriend Cachexia in NSCLC Cachexia

Smartfish

Status: Completed

Conditions: Cachexia; NSCLC

Treatments: Dietary Supplement: Isocaloric placebo; Dietary Supplement: Nutrifriend Cachexia

Study type: Interventional

Funder types: Industry

Identifiers

NCT02515032

SF-C002

Details and patient eligibility

About

SF-C002 is a pilot study in patients with newly diagnosed NSCLC suffering from involuntary weight loss. The study is 12 weeks, double-blinded, placebo controlled and the main objective is to study the safety and tolerability of Nutrifriend Cachexia.

Full description

This study is a 12-week, randomised, parallel group, placebo controlled, multi-centre study. The primary objective is to evaluate the safety and tolerability of Nutrifriend Cachexia in patients with NSCLC. The secondary objectives of the study are to evaluate effects on body composition, muscle function, daily activity, inflammation, tumor growth, compliance, appetite and Quality of Life.

Enrollment: 56 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• First-line standard chemotherapy as curative or palliative treatment for NSCLC
• Will start the first cycle of standard chemotherapy
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
• Involuntary weight loss

Exclusion criteria

• Another invasive malignancy in the last 2 years.
• Previous relapse of NSCLC within 2 years of randomisation
• Other cachectic disorders such as renal or hepatic disorders

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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56 participants in 2 patient groups, including a placebo group

NF Cachexia

Experimental group

Description:

Nutrifriend Cachexia, an Omega-3 enriched fruit juice (non complete dietary formula).

Treatment:

Dietary Supplement: Nutrifriend Cachexia

Placebo

Placebo Comparator group

Description:

An isocaloric placebo comparator

Treatment:

Dietary Supplement: Isocaloric placebo