Nutrition Therapy Promotes Overall Survival in Cachectic Cancer Patients through a New Proposed Chemical-Physical Pathway: The TiCaCONCO Trial (A Randomized Controlled Single-Blinded Trial)

Cancer threatens nutritional status, and many patients will become cachectic with a negative impact on prognosis. In the TiCaCo pilot trial, we showed a positive effect of calorie matching Nutrition Therapy on both morbidity and mortality. We attempt to validate these results in the TiCaCONCO trial. In a prospective, randomized, single-blinded, controlled trial, patients were treated with either intensive, individual biometric parameter-oriented dietary counseling (nutrition therapy or NT) for a maximum period of three months, or regular dietary counseling (control or CT), before and during conventional cancer treatment. Sixty patients were enrolled over a two-year period, with 30 receiving nutrition therapy and 30 being controls. The primary endpoint was overall survival (OS). Overall survival at 12 months in all patients was 47% (14/30 patients) in the CT group with a median OS of 45.5 weeks, and 73% (22/30 patients) in the NT group with a median OS that was undefined (i.e., cannot be calculated, as >50% of patients in the NT group were still alive at the end of the study) ( p = 0.0378). The survival difference still exists when only male patients are analyzed, but is not observed in female patients. Biophysical measurements were performed at 0, 3, and 12 months in all patients. In men, the differences between CT vs NT were statistically significant for body hydration ( p = 0.0400), fat mass ( p = 0.0480), total energy expenditure ( p = 0.0320), and median overall survival at 12 months ( p = 0.0390). At 3 months (end of the intervention), the differences between CT vs NT for body hydration were 73 ± 3% vs. 75 ± 5%, for fat mass 14 ± 4% vs. 19 ± 5%, and for total energy expenditure 2231 ± 637 Kcal vs. 2408 ± 369 Kcal. In women, the differences between CT vs NT were not statistically significant for body hydration ( p = 1.898), fat mass ( p = 0.9495), total energy expenditure ( p = 0.2875) and median overall survival at 12 months ( p = 0.6486). At 3 months (end of the intervention), the differences between CT vs. NT for body hydration were 74 ± 2% vs. 78 ± 5%, for fat mass 25 ± 7% vs. 29 ± 19%, and for TEE 1657 ± 297 Kcal vs. 1917 ± 120 Kcal. Nutrition Therapy, based on patient-specific biophysical parameters, including the measurement of metabolism by indirect calorimetry and body composition measurements by BIA, improves overall survival, at least in men. The mechanism would be increasing extra energy for the body, which is necessary to fight off cancer.