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

NCT03355079 | Terminated Phase 4

• 1 other identifier: SMKV-013-CP4
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in total body weight (kg)

  Every 2-3 weeks, for up to 9 +/-1 weeks

Secondary Outcomes (23)

• Serum albumin

  Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline

• Serum transthyretin

  Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline

• Nutritional Risk Index

  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

  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

  Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline

Other Outcomes (29)

• Aspartate Aminotransferase

  From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline

• Alanine Aminotransferase

  From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline

• Alkaline phosphatase

  From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline

Study Arms (2)

SmofKabiven® E + standard oral nutrition

EXPERIMENTAL

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

Standard oral nutrition

NO INTERVENTION

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.

Interventions

SmofKabiven® E 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.

SmofKabiven® E + standard oral nutrition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fresenius Kabi: lead

Study Sites (1)

Hôpital Cochin

Paris, 75014, France

Location

Study Officials

• Jean-Philippe Durand, MD

  Hôpital Cochin, Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2017
• First Posted: November 28, 2017
• Study Start: February 28, 2018
• Primary Completion: April 5, 2019
• Study Completion: April 5, 2019
• Last Updated: May 1, 2019

Record last verified: 2019-04

Locations

FR (1)