Alim‐K.
| Trial name or title | Efficacy of parenteral nutrition in patients at the palliative phase of cancer (Alim‐K) |
| Methods | Multicenter randomised clinical trial, France |
| Participants | Hospitalised adults, aged > 18 years suffering from cancer at the palliative stage, i.e. patients in whom the main aim of treatment is to limit pain and discomfort, curative treatment has either been discontinued, or may still be ongoing but with little expected benefit in terms of overall survival. Life expectancy must be > 2 months, participants must have a functional digestive tract, present malnutrition defined as a BMI < 18.5 kg/m² in those aged < 70 years or < 21 kg/m² in those aged ≥70 years; or weight loss of 2% in 1 week, 5% in 1 month, or 10% in 6 months, participants with antalgic radiotherapy or scheduled to undergo palliative surgery; participants must already have a functional central venous catheter in place. Exclusion criteria: non‐functional digestive tract (intestinal occlusion, tumour compression, subocclusive peritoneal carcinosis), any disorder preventing oral ingestion (cancer of the upper aerodigestive tract, oesophagus or stomach); parenteral nutrition that is ongoing or dating from < 1 month; intravenous chemotherapy through a pump lasting > 48 hours, as this is incompatible with administration of parenteral nutritional through the central venous line; presence of gastrostomy or jejunostomy; persisting sensation of hunger in aphagic patients with haematological cancers undergoing bone marrow transplant, acute renal failure (defined as creatinine clearance < 30 ml/min) or heart failure (defined as a left ventricular ejection fraction < 30%); adult patients under legal guardianship unable to respond to the 'quality of life' questionnaire (due to psychiatric disorders, attention disorders, or cognitive disorders). Patients participating in another ongoing clinical trial |
| Interventions | Experimental group: Parenteral nutrition Control group: Standard care |
| Outcomes | Quality of life, survival, body weight, albumin, C‐Reactive Protein |
| Starting date | May 2014 |
| Contact information | raubry@chu‐besancon.fr |
| Notes | Status: Currently recruiting. Expected finish June 2016 NCT02151214 |