## Protocol Section
### Identification Module
**NCT ID:** 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

#### Organization Study ID Info
**ID:** SMKV-013-CP4
#### Organization
**Class:** INDUSTRY
**Full Name:** Fresenius Kabi
### Status Module
#### Completion Date
**Date:** 2019-04-05

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-05-01

**Type:** ACTUAL

**Last Update Submit Date:** 2019-04-29

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2019-04-05

**Type:** ACTUAL

#### Start Date
**Date:** 2018-02-28

**Type:** ACTUAL

**Status Verified Date:** 2019-04

#### Study First Post Date
**Date:** 2017-11-28
**Type:** ACTUAL
**Study First Submit Date:** 2017-11-16
**Study First Submit QC Date:** 2017-11-21
**Why Stopped:** Low Patient Recruitment
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Fresenius Kabi

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Cancer-related Malnutrition

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 2

**Type:** ACTUAL

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**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.

**Intervention Names:**

- Drug: SmofKabiven® E

**Label:** SmofKabiven® E + standard oral nutrition

**Type:** EXPERIMENTAL

#### Arm Group 2

**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.

**Label:** Standard oral nutrition

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- SmofKabiven® E + standard oral nutrition

**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.

**Name:** SmofKabiven® E

**Type:** DRUG

### Outcomes Module

#### Other Outcomes

**Measure:** Aspartate Aminotransferase

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

**Measure:** Alanine Aminotransferase

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

**Measure:** Alkaline phosphatase

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

**Measure:** Gamma-Glutamyl Transferase

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

**Measure:** Direct bilirubin

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

**Measure:** Total bilirubin

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

**Measure:** Internal Normalized Ratio

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

**Measure:** Serum creatinine

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

**Measure:** Serum urea

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

**Measure:** Serum sodium

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

**Measure:** Serum potassium

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

**Measure:** Serum total calcium

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

**Measure:** Serum magnesium

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

**Measure:** Serum chloride

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

**Measure:** Serum phosphate

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

**Measure:** Serum bicarbonate

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

**Measure:** Serum glucose

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

**Measure:** Serum triglycerides

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

**Measure:** Red blood cell count

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

**Measure:** Total white blood cell count

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

**Measure:** Differential blood count

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

**Measure:** Haemoglobin

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

**Measure:** Haematocrit

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

**Measure:** Platelet count

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

**Measure:** C-reactive protein

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

**Measure:** Blood pressure

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

**Measure:** Heart rate

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

**Measure:** Body temperature

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

**Measure:** 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

#### Primary Outcomes

**Measure:** Change in total body weight (kg)

**Time Frame:** Every 2-3 weeks, for up to 9 +/-1 weeks

#### Secondary Outcomes

**Measure:** Serum albumin

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

**Measure:** Serum transthyretin

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

**Measure:** Nutritional Risk Index

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

**Measure:** 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

**Measure:** 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

**Measure:** 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

**Measure:** 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

**Measure:** Karnofsky performance status

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

**Measure:** ECOG performance status

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

**Measure:** Handgrip strength in kg, using hand dynamometer

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

**Measure:** Actual and target number of completed chemotherapy and/or immunotherapy cycles

**Time Frame:** Every 2-3 weeks from baseline to 3 months after baseline

**Measure:** Actual dose and target chemotherapy and/or immunotherapy dose administered

**Time Frame:** Every 2-3 weeks from baseline to 3 months after baseline

**Measure:** 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

**Measure:** 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

**Measure:** Overall survival

**Time Frame:** Until 6 months post baseline

**Measure:** Progression-free survival

**Time Frame:** At 3 and 6 months post baseline

**Measure:** Partial response rate (as per RECIST v 1.1)

**Time Frame:** At 9 +/-1 weeks, 3 months and 6 months after baseline

**Measure:** Complete response rate (as per RECIST v 1.1)

**Time Frame:** At 9 +/-1 weeks, 3 months and 6 months after baseline

**Measure:** Unplanned hospitalization

**Time Frame:** From baseline until 6 months after baseline

**Measure:** 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

**Measure:** 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

**Description:** measured by indirect calorimetry

**Measure:** Resting energy expenditure

**Time Frame:** From baseline until final visit at 9 +/-1 weeks after baseline

**Measure:** Ocurrence of unplanned admission to nursing home

**Time Frame:** From baseline until final visit at 9 +/-1 weeks after baseline

### Eligibility Module

**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 Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Paris

**Country:** France

**Facility:** Hôpital Cochin

**Zip:** 75014

#### Overall Officials

**Official 1:**

**Affiliation:** Hôpital Cochin, Paris

**Name:** Jean-Philippe Durand, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009748

- Term: Nutrition Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

### Condition Browse Module - Browse Leaves

- ID: M11172

- Name: Lung Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M5546

- Name: Carcinoma, Non-Small-Cell Lung

- Relevance: LOW

- As Found: Unknown

- ID: M25306

- Name: Malnutrition

- Relevance: HIGH

- As Found: Malnutrition

- ID: M12684

- Name: Nutrition Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000044342

- Term: Malnutrition

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M2853

- Name: Immunomodulating Agents

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
