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

April 29, 2019 updated by: Fresenius Kabi

Efficacy of Long-term Parenteral Nutrition With SmofKabiven® E Concomitant to Chemo- and/or Immunotherapy: A Prospective, Randomised, Controlled, Open, Multicentre, Two-stage, Adaptive Clinical Trial in Metastatic Non-small Cell Lung Cancer

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75014
        • Hôpital Cochin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Metastatic non-small cell lung cancer patient
  • Adult ≥ 18 years
  • Starting any 1st, 2nd or 3rd line chemotherapy and/or immunotherapy administered via a central venous catheter (including implanted ports), or receiving the 2nd cycle of aforementioned anticancer treatment
  • An energy gap of ≥ 40 % and/or 1000 kcal between the target energy intake (30 ± 5 kcal/kg/day) and the actual energy intake at screening, irrespective of weight loss
  • Functional digestive tract allowing oral intake
  • If female of childbearing potential, willing to use a sufficiently safe contraception method throughout participation in the study
  • Signed informed consent from patient or legal representative

Exclusion Criteria:

  • Parenteral nutrition (PN) administered during the preceding month (the sole administration of intravenous glucose is allowed), or standard of care PN planned to start within 3 weeks after baseline visit
  • More than 1600 kcal/day required as PN
  • Tube feeding at screening, or planned to start within 3 weeks after baseline visit
  • Body mass index (BMI) > 30 kg/m2
  • Performance status > 3 Eastern Cooperative Oncology Group (ECOG) score
  • Life expectancy < 3 months
  • Active bloodstream infection demonstrated by positive blood culture at Screening
  • Hypersensitivity to fish-, egg, soya- or peanut protein or to any of the active substances or excipients in SmofKabiven E
  • Severe blood coagulation disorders
  • Congenital errors of amino acid metabolism
  • Pathologically elevated serum levels of any of the included electrolytes
  • General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration, decompensated cardiac insufficiency
  • Hemophagocytotic Syndrome
  • Severe hyperlipidemia (serum triglycerides > 353 mg/dL)
  • Severe liver insufficiency: liver enzymes (aspartate aminotransferase [AST], alanine aminotransferase [ALT], gamma glutamyl transferase [GGT]) or conjugated bilirubin exceeding 3 x upper limit of normal range, or International Normalised Ratio (INR) > 2
  • Severe renal dysfunction (estimated glomerular filtration rate [eGFR] < 30 ml/min/1.73m2) and patients on renal replacement therapy
  • Uncontrolled hyperglycaemia
  • Unstable conditions (e.g., embolism, metabolic acidosis, hypotonic dehydration)
  • Pregnancy or lactation
  • Contraindications to any of the study assessment methods including computer tomography and indirect calorimetry
  • Participation in a clinical study with an investigational drug or investigational medical device within one month prior to start of study or during study
  • Prior inclusion in the present study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SmofKabiven® E + standard oral nutrition
SmofKabiven® E, with or without addition of Suppliven®, Vitalipid® Adult and/or Soluvit® will be administered at 5-7 days per week for up to 9 +/-1 weeks in addition to standard of care oral nutrition as per routine dietary counseling, to reach the patient's target energy intake.
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.
No Intervention: Standard oral nutrition
The patients will consume standard of care oral nutrition as per routine dietary counseling, to reach their target energy intake. Standard of care tube feeding or parenteral nutrition is allowed to start earliest 3 weeks after baseline visit, if required.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in total body weight (kg)
Time Frame: Every 2-3 weeks, for up to 9 +/-1 weeks
Every 2-3 weeks, for up to 9 +/-1 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Serum albumin
Time Frame: Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline
Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline
Serum transthyretin
Time Frame: Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline
Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline
Nutritional Risk Index
Time Frame: Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline
Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline
Unplanned PN or tube feeding according to standard of care in control group
Time Frame: Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline
Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline
Early termination of PN due to improvement in test group
Time Frame: Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline
Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline
Lean body mass determined from computer tomography (CT) scan at 3rd lumbar vertebra
Time Frame: Baseline to final visit at 9 +/1 weeks after baseline
Baseline to final visit at 9 +/1 weeks after baseline
Optional: lean tissue mass, phase angle and hydration status including intra- and extracellular body water with bioelectrical impedance analysis (BIA), if BIA device is available.
Time Frame: Baseline to final visit at 9 +/1 weeks after baseline
Baseline to final visit at 9 +/1 weeks after baseline
Karnofsky performance status
Time Frame: Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline
Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline
ECOG performance status
Time Frame: Time Frame: Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline
Time Frame: Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline
Handgrip strength in kg, using hand dynamometer
Time Frame: Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline
Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline
Actual and target number of completed chemotherapy and/or immunotherapy cycles
Time Frame: Every 2-3 weeks from baseline to 3 months after baseline
Every 2-3 weeks from baseline to 3 months after baseline
Actual dose and target chemotherapy and/or immunotherapy dose administered
Time Frame: Every 2-3 weeks from baseline to 3 months after baseline
Every 2-3 weeks from baseline to 3 months after baseline
Chemotherapy and/or immunotherapy toxicities according to NCI-CTC v4.0 including dose-limiting toxicities
Time Frame: Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline
Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline
Fatigue using the brief fatigue inventory (BFI questionnaire)
Time Frame: Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline
Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline
Overall survival
Time Frame: Until 6 months post baseline
Until 6 months post baseline
Progression-free survival
Time Frame: At 3 and 6 months post baseline
At 3 and 6 months post baseline
Partial response rate (as per RECIST v 1.1)
Time Frame: At 9 +/-1 weeks, 3 months and 6 months after baseline
At 9 +/-1 weeks, 3 months and 6 months after baseline
Complete response rate (as per RECIST v 1.1)
Time Frame: At 9 +/-1 weeks, 3 months and 6 months after baseline
At 9 +/-1 weeks, 3 months and 6 months after baseline
Unplanned hospitalization
Time Frame: From baseline until 6 months after baseline
From baseline until 6 months after baseline
Quality of life (Functional Assessment of Cancer Therapy- General [FACT-G] score)
Time Frame: From baseline until final visit at 9 +/-1 weeks after baseline
From baseline until final visit at 9 +/-1 weeks after baseline
Number of patients terminating anti-cancer and nutrition therapy as part of end-of-life care
Time Frame: From baseline until final visit at 9 +/-1 weeks after baseline
From baseline until final visit at 9 +/-1 weeks after baseline
Resting energy expenditure
Time Frame: From baseline until final visit at 9 +/-1 weeks after baseline
measured by indirect calorimetry
From baseline until final visit at 9 +/-1 weeks after baseline
Ocurrence of unplanned admission to nursing home
Time Frame: From baseline until final visit at 9 +/-1 weeks after baseline
From baseline until final visit at 9 +/-1 weeks after baseline

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Aspartate Aminotransferase
Time Frame: From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
Alanine Aminotransferase
Time Frame: From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
Alkaline phosphatase
Time Frame: From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
Gamma-Glutamyl Transferase
Time Frame: From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
Direct bilirubin
Time Frame: From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
Total bilirubin
Time Frame: From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
Internal Normalized Ratio
Time Frame: From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
Serum creatinine
Time Frame: From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
Serum urea
Time Frame: From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
Serum sodium
Time Frame: From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
Serum potassium
Time Frame: From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
Serum total calcium
Time Frame: From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
Serum magnesium
Time Frame: From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
Serum chloride
Time Frame: From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
Serum phosphate
Time Frame: From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
Serum bicarbonate
Time Frame: From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
Serum glucose
Time Frame: From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
Serum triglycerides
Time Frame: From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
Red blood cell count
Time Frame: From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
Total white blood cell count
Time Frame: From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
Differential blood count
Time Frame: From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
Haemoglobin
Time Frame: From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
Haematocrit
Time Frame: From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
Platelet count
Time Frame: From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
C-reactive protein
Time Frame: From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
Blood pressure
Time Frame: From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
Heart rate
Time Frame: From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
Body temperature
Time Frame: From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
Infection rate including catheter-related blood stream infections demonstrated by positive blood culture
Time Frame: From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fresenius Kabi

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jean-Philippe Durand, MD, Hôpital Cochin, PARIS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 28, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 5, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 5, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 16, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 28, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SMKV-013-CP4

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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