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Low Patient Recruitment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SmofKabivenĀ® E + standard oral nutrition | Experimental | SmofKabivenĀ® E, with or without addition of SupplivenĀ®, VitalipidĀ® Adult and/or SoluvitĀ® 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SmofKabivenĀ® E | Drug | In the intervention arm, SmofKabivenĀ® E, with or without addition of SupplivenĀ®, VitalipidĀ® Adult and/or SoluvitĀ®, 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in total body weight (kg) | Every 2-3 weeks, for up to 9 +/-1 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Philippe Durand, MD | HĆ“pital Cochin, Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HĆ“pital Cochin | Paris | 75014 | France |
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| 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 |
| Lean body mass determined from computer tomography (CT) scan at 3rd lumbar vertebra | Baseline to final visit at 9 +/1 weeks after baseline |
| 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 |
| Karnofsky performance status | Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline |
| ECOG performance status | Time Frame: Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline |
| Handgrip strength in kg, using hand dynamometer | Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline |
| Actual and target number of completed chemotherapy and/or immunotherapy cycles | Every 2-3 weeks from baseline to 3 months after baseline |
| Actual dose and target chemotherapy and/or immunotherapy dose administered | Every 2-3 weeks from baseline to 3 months after baseline |
| 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 |
| Fatigue using the brief fatigue inventory (BFI questionnaire) | Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline |
| Overall survival | Until 6 months post baseline |
| Progression-free survival | At 3 and 6 months post baseline |
| Partial response rate (as per RECIST v 1.1) | At 9 +/-1 weeks, 3 months and 6 months after baseline |
| Complete response rate (as per RECIST v 1.1) | At 9 +/-1 weeks, 3 months and 6 months after baseline |
| Unplanned hospitalization | From baseline until 6 months after baseline |
| Quality of life (Functional Assessment of Cancer Therapy- General [FACT-G] score) | From baseline until final visit at 9 +/-1 weeks after baseline |
| 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 |
| Resting energy expenditure | measured by indirect calorimetry | From baseline until final visit at 9 +/-1 weeks after baseline |
| Ocurrence of unplanned admission to nursing home | From baseline 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 |
| Gamma-Glutamyl Transferase | From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline |
| Direct bilirubin | From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline |
| Total bilirubin | From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline |
| Internal Normalized Ratio | From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline |
| Serum creatinine | From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline |
| Serum urea | From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline |
| Serum sodium | From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline |
| Serum potassium | From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline |
| Serum total calcium | From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline |
| Serum magnesium | From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline |
| Serum chloride | From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline |
| Serum phosphate | From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline |
| Serum bicarbonate | From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline |
| Serum glucose | From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline |
| Serum triglycerides | From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline |
| Red blood cell count | From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline |
| Total white blood cell count | From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline |
| Differential blood count | From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline |
| Haemoglobin | From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline |
| Haematocrit | From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline |
| Platelet count | From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline |
| C-reactive protein | From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline |
| Blood pressure | From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline |
| Heart rate | From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline |
| Body temperature | From baseline every 2-3 weeks until final visit at 9 +/-1 weeks after baseline |
| 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 |