Tight Caloric Control in the Cachectic Oncologic Patient (TiCaCONCO or CoCooN) Can Stabilize Body Weight, Thereby Reducing Morbidity and Mortality: Validation of the Pilot Study - A Randomized Controlled Double-Blind Trial

In the investigators' pilot trial, 20 patients were randomized, 10 receiving regular counseling by regular oncodietitians, while the 10 others received nutrition therapy. In the latter group, an assessment of biophysical parameters was made (including the Bioelectrical Impedance Analysis or BIA for body composition), and the patients' Energy Expenditure was assessed using indirect calorimetry. Afterwards, the patients received nutrition therapy according to the ESPEN (European Society for Parenteral and Enteral Nutrition) guidelines. Supplementary interventions were made to match caloric intake to energy expenditure (the 'Tight Caloric' approach), using enteral and parenteral nutrition if indicated, by an intensive coaching and follow-up to continue this nutrition strategy (with dieticians even being "on call" after hours). While the study follow-up lasted 2 years, nutrition therapy was only performed during the first 3 months. The results were striking: apart from keeping their body weight in balance, the patients of the nutrition therapy group counted much less unexpected hospitalisation days and they clearly lived much longer .

This project targets the validation of these results on a large scale. For this study, patients with either colorectal adenocarcinoma, lung carcinoma, oesofageal carcinoma, gastric carcinoma, pancreatic carcinoma and head and neck cancer, due to the high prevalence of cachexia in these patients will be included. A weight loss can also occur during treatment, and does not need to be present at the start of the study. Patients will be randomized, and the study is intended to be be double-blinded, although this will be difficult to maintain in practice due to the nature of the treatment. The recruitment phase will last 2 years, keeping refusals and dropouts in mind. Follow-up will last 1 year after inclusion, although the actual nutrition therapy will again last only during therapy (3 months for chemotherapy, 6 weeks for radiotherapy): the period of active oncological treatment. An intermediate analysis is already made after 6 months of follow-up. In case survival is already statistically significant, the trial will be stopped for ethical reasons. In case of a positive result, the investigators want to implement nutrition therapy as a standard treatment in cachectic cancer patients in Belgium.

In case of a positive outcome (i.e. mere confirmation of our published results), the major advantage of nutrition therapy will be its relatively low cost while still affecting morbidity and mortality significantly. This can be practically achieved by redefining the dietician's task. The patient's own active participation in the decision making process is an important surplus in well-being and overall treatment. In combination with decreased morbidity and mortality the benefit of the patient can be found on every level.

Protocol Amendment dd 12/06/2017

Background: