patients with indication to first line chemiotherapy MedDRA version: 9.1 Level: LLT Classification code 10062042 Term: Lung neoplasm
Conditions
Interventions
Trade Name: ESKIM*20CPS MOLLI 1000MG
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Omega-3-triglycerides
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1
Sponsors
AZIENDA SANITARIA OSPEDALIERA "S. GIOVANNI BATTISTA DI TORINO"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - weight loss =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - presence of metastasis - acute infections
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: evaluate PUFAw-3 influence on - tollerance and completion of chemiotherapy - adhesion to the schedula of treatment - toxicity of chemiotherapy treatment;Primary end point(s): - failure = stop of chemiotherapy because of bad tollerance and/or high toxicity - success = completion of chemiotherapy;Secondary Objective: 1)evaluation of PUFAw-3 influence on inflammatory activation and oxidative status markers to evaluate the effect of cancer cachexia on : - pro-inflammatory citokynes and their receptors - oxidative stress markers 2)evaluation of PUFAw-3 influence on subjective markers: - quality of life and performance status - fatigue 3)evaluation of PUFAw-3 influence on nutritional status markers: - body weight, BMI, body composition - biochemical markers: acute fase proteins, visceral synthesis proteins - oral intake 4)evaluate clinical outcome at the end of chemiotherapy | — |
Countries
Italy
Outcome results
None listed