Pilot Study of Safety and Tolerability of Nutrifriend Cac... | NCT02515032

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

NCT02515032

Sponsor

Smartfish AS

Status

Completed

Last Update Posted

Jul 17, 2017Actual

Enrollment

56Actual

Phase

Not Applicable

Conditions

Cachexia
NSCLC

Interventions

Nutrifriend Cachexia
Isocaloric placebo

Countries

Croatia
Italy
Slovakia
Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2015Actual

Primary Completion Date

May 2017Actual

Completion Date

May 2017Actual

First Submitted Date

Jul 28, 2015

First Submission Date that Met QC Criteria

Jul 30, 2015

First Posted Date

Aug 4, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 12, 2017

Last Update Posted Date

Jul 17, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

56Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Nutrifriend Cachexia	Dietary Supplement	2 daily for 12 weeks	NF Cachexia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety and tolerability assessed by (adverse events, concomitant medication and laboratory markers) of Nutrifriend Cachexia in patients with NSCLC		12 weeks

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Measure	Description	Time Frame
Response to chemotherapy by tumor growth		12 weeks
Overall survival		52 weeks
Exploratory biomarkers related to cachexia, e.g. carnosine, beta-alanine

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Maurizio Muscaritoli, Prof.	University Hospital Sapienza	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GH Varaždin		Varaždin		42 000	Croatia
GH Zadar

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31290697	Derived	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.

ID	Term
D015431	Weight Loss
D001836	Body Weight Changes
D001835	Body Weight
D012816	Signs and Symptoms