Efficacy Study of Long-term Parenteral Nutrition With SmofKabiven® E in Lung Cancer Patients Unde⦠(NCT03355079) | Clinical Trial Compass
TerminatedPhase 4
Efficacy Study of Long-term Parenteral Nutrition With SmofKabivenĀ® E in Lung Cancer Patients Under Anticancer Therapy
Stopped: Low Patient Recruitment
France2 participantsStarted 2018-02-28
Plain-language summary
The purpose of this study is to determine the efficacy of long-term addition of SmofKabivenĀ® 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Metastatic non-small cell lung cancer patient
* Adult ā„ 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
* Patholā¦
What they're measuring
1
Change in total body weight (kg)
Timeframe: Every 2-3 weeks, for up to 9 +/-1 weeks