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Efficacy Study of Long-term Parenteral Nutrition With SmofKabiven® E in Lung Cancer Patients Under Anticancer Therapy

NCT03355079 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2019-05-01

No results posted yet for this study

Summary

The purpose of this study is to determine the efficacy of long-term addition of SmofKabiven® E to normal oral nutrition after routine dietary counseling as compared to standard of care nutrition in which oral nutrition is the primary nutritional support. It takes place in lung cancer patients under chemo- and/or immunotherapy. Efficacy will be determined primarily by calculating the change of patient's body weight from before start of study treatment to end of treatment, and comparing this change between both treatment groups.

Conditions

  • Cancer-related Malnutrition

Interventions

DRUG

SmofKabiven® E

In the intervention arm, SmofKabiven® E, with or without addition of Suppliven®, Vitalipid® Adult and/or Soluvit®, will be administered in addition to standard of care oral nutrition as per dietary counseling, whereas in the control arm, oral nutrition as per dietary counseling is the primary nutritional support.

Sponsors & Collaborators

  • Fresenius Kabi

    lead INDUSTRY

Principal Investigators

  • Jean-Philippe Durand, MD · Hôpital Cochin, Paris

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-28
Primary Completion
2019-04-05
Completion
2019-04-05

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03355079 on ClinicalTrials.gov