Evaluation of the Quality of Life of Patients With Metastatic Non-small Cell Lung Cancer With Supplementary Therapy With IGEN-0206

This is an interventional treatment trial for Quality of Life of Patients Read More

Inclusion Criteria:

• Patient who has given informed consent in writing, stating that he / she understands the purpose of the study and the procedures it entails, and that he / she agrees to participate.
• Patient with metastatic non-small cell lung carcinoma confirmed by Pathology.
• Expected life expectancy exceeding 12 weeks.
• Age ≥18 years.
• Functional status of the ECOG 1-3.
• Patients who can consume at least 500 ml per day of the nutritional supplement, added to their diet.
• Patients who do not meet criteria for renal failure: the glomerular filtrate, calculated by local formula, must be ≥60 ml / min / 1.73m2.
• Patients who are willing to communicate the use of nutritional supplements, including oral supplements, vitamins and mineral supplements and / or any food supplement
• Patients who are willing to comply with the protocol procedures after having been thoroughly informed about the treatment, the procedures, reviewing the study methodology and signing the informed consent.
• They speak fluent Spanish in order to be able to complete the questionnaires of the study.
• Potentially fertile women must be negative in a serum pregnancy test performed within 7 days prior to entry into the study. Potentially fertile patients participating in this study should use effective contraceptive methods (eg, abstinence, intrauterine device, oral or injectable contraceptives, double-barrier method, or surgical sterilization) to prevent pregnancy, which they will begin to use as of signature of the informed consent document and whose use will continue until at least 13 weeks after the last dose of the study medication has been administered.

Exclusion Criteria:

• Women who are pregnant and / or breast-feeding.
• Persistence of the toxicity of a previous treatment (grade> 1 of the NCI-CTCAE v. 4.03); However, alopecia and sensory neuropathy of grade ≤ 2 are acceptable, as well as other side effects that do not endanger patient safety in the opinion of the researcher.
• Evidence of severe or uncontrolled systemic disease or concomitant process that, in the opinion of the investigator, makes the participation of the subject in the study inadvisable or compromises compliance with the protocol.
• Dementia or mental state significantly altered that could interfere in the understanding and granting of informed consent.
• Parkinson's disease