NCT02515032

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable

Geographic Reach
4 countries

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

July 28, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 4, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

July 17, 2017

Status Verified

July 1, 2017

Enrollment Period

1.8 years

First QC Date

July 28, 2015

Last Update Submit

July 12, 2017

Conditions

CachexiaNSCLC

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability assessed by (adverse events, concomitant medication and laboratory markers) of Nutrifriend Cachexia in patients with NSCLC

    12 weeks

Secondary Outcomes (16)

  • Body composition assessed by fat mass and lean body mass (LBM)

    12 weeks

  • Body composition assessed by weight

    12 weeks

  • Body composition assessed by BMI

    12 weeks

  • Body composition assessed by waist circumference

    12 weeks

  • Body composition assessed by calf circumference

    12 weeks

  • +11 more secondary outcomes

Other Outcomes (3)

  • Response to chemotherapy by tumor growth

    12 weeks

  • Overall survival

    52 weeks

  • Exploratory biomarkers related to cachexia, e.g. carnosine, beta-alanine

    12 weeks

Study Arms (2)

NF Cachexia

EXPERIMENTAL

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

Dietary Supplement: Nutrifriend Cachexia

Placebo

PLACEBO COMPARATOR

An isocaloric placebo comparator

Dietary Supplement: Isocaloric placebo

Interventions

Nutrifriend CachexiaDIETARY_SUPPLEMENT

2 daily for 12 weeks

Also known as: NFCax
NF Cachexia
Isocaloric placeboDIETARY_SUPPLEMENT

2 daily for 12 weeks

Also known as: Placobo
Placebo

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

GH Varaždin

Varaždin, 42 000, Croatia

Location

GH Zadar

Zadar, 23 000, Croatia

Location

CHC Sestre Milosrdnice

Zagreb, 10 000, Croatia

Location

CHC Zagreb,

Zagreb, 10 000, Croatia

Location

Policlinico Universitario Campus Bio-Medico di Roma

Rome, 00128, Italy

Location

Policlinico Tor Vergata

Rome, 00133, Italy

Location

Azienda Ospedaliera San Camillo Forlanini

Rome, 00151, Italy

Location

FNsP F.D. Roosvelta Banská Bystrica

Banská Bystrica, 975 17, Slovakia

Location

Nemocnica Sv. Jakuba

Bardejov, 085 01, Slovakia

Location

Východoslovenský onkologický ústav

Košice, 041 91, Slovakia

Location

NsP Štefana Kukuru Michalovce

Michalovce, 071 01, Slovakia

Location

FNsP J.A. Reimana

Prešov, 081 81, Slovakia

Location

Linkoping University Hospital

Linköping, 58185, Sweden

Location

Akademiska hospital

Uppsala, 751 85, Sweden

Location

Related Publications (1)

  • Laviano A, Calder PC, Schols AMWJ, Lonnqvist F, Bech M, Muscaritoli M. Safety and Tolerability of Targeted Medical Nutrition for Cachexia in Non-Small-Cell Lung Cancer: A Randomized, Double-Blind, Controlled Pilot Trial. Nutr Cancer. 2020;72(3):439-450. doi: 10.1080/01635581.2019.1634746. Epub 2019 Jul 10.

    PMID: 31290697DERIVED

MeSH Terms

Conditions

Cachexia

Condition Hierarchy (Ancestors)

Weight LossBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsThinness

Study Officials

  • Maurizio Muscaritoli, Prof.

    University Hospital Sapienza

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2015

First Posted

August 4, 2015

Study Start

July 1, 2015

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

July 17, 2017

Record last verified: 2017-07

Locations

IT(3)SL(5)SE(2)CR(4)