Chemotherapy-related Toxicity, Nutritional Status and Quality of Life

Chemotherapy-related Toxicity, Nutritional Status and Quality of Life in Precachectic Oncologic Patients With or Without High Protein Nutritional Support. A Prospective, Randomized Study

Determine whether nutritional support with high protein ONS in adult oncologic patients in the first step of cancer cachexia - asymptomatic precachexia, influence on the toxicity of systemic therapy.

Other endpoints:

• to determine whether high protein ONS influence on the nutritional status
• to determine whether high protein ONS influence on the quality of life
• to determine whether high protein ONS influence on the performance status
• to determine high protein ONS tolerability / ONS intake compliance

Inclusion Criteria:

• histological confirmed diagnosis of CRC in clinical stage IV
• successful qualification to chemotherapy
• performance status at least 80% according to Karnofsky scale and <2 according to WHO/ECOG scale
• cancer-related asymptomatic precachexia diagnosed
• absence of contraindications to oral nutrition and practicable realization of oral nutrition
• absence of severe, decompensated concomitant diseases
• signed informed consent for the participation in the study

Exclusion Criteria:

• diagnosis of a malignant neoplasm in clinical stage I-III
• disqualification from oncologic treatment
• cancer cachexia or cancer anorexia-cachexia syndrome
• poor performance status
• contraindications to oral nutrition or to high protein nutrition
• regular nutritional support at the moment of qualification to the study
• patient incompliance at the moment of qualification to the study