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

NCT ID: NCT03355079

Last Updated: 2019-05-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-28
• Study Completion Date: 2019-04-05

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.

Conditions

Cancer-related Malnutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

SmofKabiven® E

Intervention Type: DRUG

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fresenius Kabi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Philippe Durand, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Cochin, Paris

Locations

Hôpital Cochin

Paris, , France

Countries

France

Other Identifiers

SMKV-013-CP4

Identifier Type: -

Identifier Source: org_study_id