Back to resultsEfficacy Study of Long-term Parenteral Nutrition With SmofKabiven® E in Lung Cancer Patients Under Anticancer Therapy
Primary Purpose
Cancer-related Malnutrition
Status
Terminated
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
SmofKabiven® E
Sponsored by
About this trial
This is an interventional supportive care trial for Cancer-related Malnutrition
Eligibility Criteria
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
Sites / Locations
- Hôpital Cochin
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
SmofKabiven® E + standard oral nutrition
Standard oral nutrition
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change in total body weight (kg)
Secondary Outcome Measures
Serum albumin
Serum transthyretin
Nutritional Risk Index
Unplanned PN or tube feeding according to standard of care in control group
Early termination of PN due to improvement in test group
Lean body mass determined from computer tomography (CT) scan at 3rd lumbar vertebra
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.
Karnofsky performance status
ECOG performance status
Handgrip strength in kg, using hand dynamometer
Actual and target number of completed chemotherapy and/or immunotherapy cycles
Actual dose and target chemotherapy and/or immunotherapy dose administered
Chemotherapy and/or immunotherapy toxicities according to NCI-CTC v4.0 including dose-limiting toxicities
Fatigue using the brief fatigue inventory (BFI questionnaire)
Overall survival
Progression-free survival
Partial response rate (as per RECIST v 1.1)
Complete response rate (as per RECIST v 1.1)
Unplanned hospitalization
Quality of life (Functional Assessment of Cancer Therapy- General [FACT-G] score)
Number of patients terminating anti-cancer and nutrition therapy as part of end-of-life care
Resting energy expenditure
measured by indirect calorimetry
Ocurrence of unplanned admission to nursing home
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03355079
Brief Title
Efficacy Study of Long-term Parenteral Nutrition With SmofKabiven® E in Lung Cancer Patients Under Anticancer Therapy
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Why Stopped
Low Patient Recruitment
Study Start Date
February 28, 2018 (Actual)
Primary Completion Date
April 5, 2019 (Actual)
Study Completion Date
April 5, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fresenius Kabi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer-related Malnutrition
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SmofKabiven® E + standard oral nutrition
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard oral nutrition
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
SmofKabiven® E
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in total body weight (kg)
Time Frame
Every 2-3 weeks, for up to 9 +/-1 weeks
Secondary Outcome Measure Information:
Title
Serum albumin
Time Frame
Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline
Title
Serum transthyretin
Time Frame
Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline
Title
Nutritional Risk Index
Time Frame
Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline
Title
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
Title
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
Title
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
Title
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
Title
Karnofsky performance status
Time Frame
Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline
Title
ECOG performance status
Time Frame
Time Frame: Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline
Title
Handgrip strength in kg, using hand dynamometer
Time Frame
Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline
Title
Actual and target number of completed chemotherapy and/or immunotherapy cycles
Time Frame
Every 2-3 weeks from baseline to 3 months after baseline
Title
Actual dose and target chemotherapy and/or immunotherapy dose administered
Time Frame
Every 2-3 weeks from baseline to 3 months after baseline
Title
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
Title
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
Title
Overall survival
Time Frame
Until 6 months post baseline
Title
Progression-free survival
Time Frame
At 3 and 6 months post baseline
Title
Partial response rate (as per RECIST v 1.1)
Time Frame
At 9 +/-1 weeks, 3 months and 6 months after baseline
Title
Complete response rate (as per RECIST v 1.1)
Time Frame
At 9 +/-1 weeks, 3 months and 6 months after baseline
Title
Unplanned hospitalization
Time Frame
From baseline until 6 months after baseline
Title
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
Title
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
Title
Resting energy expenditure
Description
measured by indirect calorimetry
Time Frame
From baseline until final visit at 9 +/-1 weeks after baseline
Title
Ocurrence of unplanned admission to nursing home
Time Frame
From baseline until final visit at 9 +/-1 weeks after baseline
Other Pre-specified Outcome Measures:
Title
Aspartate Aminotransferase
Time Frame
From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
Title
Alanine Aminotransferase
Time Frame
From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
Title
Alkaline phosphatase
Time Frame
From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
Title
Gamma-Glutamyl Transferase
Time Frame
From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
Title
Direct bilirubin
Time Frame
From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
Title
Total bilirubin
Time Frame
From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
Title
Internal Normalized Ratio
Time Frame
From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
Title
Serum creatinine
Time Frame
From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
Title
Serum urea
Time Frame
From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
Title
Serum sodium
Time Frame
From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
Title
Serum potassium
Time Frame
From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
Title
Serum total calcium
Time Frame
From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
Title
Serum magnesium
Time Frame
From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
Title
Serum chloride
Time Frame
From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
Title
Serum phosphate
Time Frame
From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
Title
Serum bicarbonate
Time Frame
From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
Title
Serum glucose
Time Frame
From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
Title
Serum triglycerides
Time Frame
From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
Title
Red blood cell count
Time Frame
From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
Title
Total white blood cell count
Time Frame
From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
Title
Differential blood count
Time Frame
From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
Title
Haemoglobin
Time Frame
From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
Title
Haematocrit
Time Frame
From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
Title
Platelet count
Time Frame
From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
Title
C-reactive protein
Time Frame
From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
Title
Blood pressure
Time Frame
From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
Title
Heart rate
Time Frame
From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
Title
Body temperature
Time Frame
From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Philippe Durand, MD
Organizational Affiliation
Hôpital Cochin, Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
12. IPD Sharing Statement
Learn more about this trial
Efficacy Study of Long-term Parenteral Nutrition With SmofKabiven® E in Lung Cancer Patients Under Anticancer Therapy
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