Cancer-related Malnutrition Clinical Trial
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
| Verified date | April 2019 |
| Source | Fresenius Kabi |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 2 |
| Est. completion date | April 5, 2019 |
| Est. primary completion date | April 5, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Hôpital Cochin | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Fresenius Kabi |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Aspartate Aminotransferase | From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline | ||
| Other | Alanine Aminotransferase | From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline | ||
| Other | Alkaline phosphatase | From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline | ||
| Other | Gamma-Glutamyl Transferase | From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline | ||
| Other | Direct bilirubin | From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline | ||
| Other | Total bilirubin | From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline | ||
| Other | Internal Normalized Ratio | From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline | ||
| Other | Serum creatinine | From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline | ||
| Other | Serum urea | From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline | ||
| Other | Serum sodium | From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline | ||
| Other | Serum potassium | From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline | ||
| Other | Serum total calcium | From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline | ||
| Other | Serum magnesium | From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline | ||
| Other | Serum chloride | From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline | ||
| Other | Serum phosphate | From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline | ||
| Other | Serum bicarbonate | From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline | ||
| Other | Serum glucose | From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline | ||
| Other | Serum triglycerides | From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline | ||
| Other | Red blood cell count | From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline | ||
| Other | Total white blood cell count | From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline | ||
| Other | Differential blood count | From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline | ||
| Other | Haemoglobin | From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline | ||
| Other | Haematocrit | From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline | ||
| Other | Platelet count | From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline | ||
| Other | C-reactive protein | From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline | ||
| Other | Blood pressure | From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline | ||
| Other | Heart rate | From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline | ||
| Other | Body temperature | From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline | ||
| Other | Infection rate including catheter-related blood stream infections demonstrated by positive blood culture | From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline | ||
| Primary | Change in total body weight (kg) | Every 2-3 weeks, for up to 9 +/-1 weeks | ||
| Secondary | Serum albumin | Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline | ||
| Secondary | Serum transthyretin | Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline | ||
| Secondary | Nutritional Risk Index | Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline | ||
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | Lean body mass determined from computer tomography (CT) scan at 3rd lumbar vertebra | Baseline to final visit at 9 +/1 weeks after baseline | ||
| Secondary | 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. | Baseline to final visit at 9 +/1 weeks after baseline | ||
| Secondary | Karnofsky performance status | Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline | ||
| Secondary | ECOG performance status | Time Frame: Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline | ||
| Secondary | Handgrip strength in kg, using hand dynamometer | Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline | ||
| Secondary | Actual and target number of completed chemotherapy and/or immunotherapy cycles | Every 2-3 weeks from baseline to 3 months after baseline | ||
| Secondary | Actual dose and target chemotherapy and/or immunotherapy dose administered | Every 2-3 weeks from baseline to 3 months after baseline | ||
| Secondary | Chemotherapy and/or immunotherapy toxicities according to NCI-CTC v4.0 including dose-limiting toxicities | Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline | ||
| Secondary | Fatigue using the brief fatigue inventory (BFI questionnaire) | Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline | ||
| Secondary | Overall survival | Until 6 months post baseline | ||
| Secondary | Progression-free survival | At 3 and 6 months post baseline | ||
| Secondary | Partial response rate (as per RECIST v 1.1) | At 9 +/-1 weeks, 3 months and 6 months after baseline | ||
| Secondary | Complete response rate (as per RECIST v 1.1) | At 9 +/-1 weeks, 3 months and 6 months after baseline | ||
| Secondary | Unplanned hospitalization | From baseline until 6 months after baseline | ||
| Secondary | Quality of life (Functional Assessment of Cancer Therapy- General [FACT-G] score) | From baseline until final visit at 9 +/-1 weeks after baseline | ||
| Secondary | Number of patients terminating anti-cancer and nutrition therapy as part of end-of-life care | From baseline until final visit at 9 +/-1 weeks after baseline | ||
| Secondary | Resting energy expenditure | measured by indirect calorimetry | From baseline until final visit at 9 +/-1 weeks after baseline | |
| Secondary | Ocurrence of unplanned admission to nursing home | From baseline until final visit at 9 +/-1 weeks after baseline |