A Prospective Randomized Trial: Effect of Docosahexaenoic Acid (DHA) and Eicosapentaenoic Acid (EPA)- Containing Supplement on the Nutritional and Inflammatory Status, Quality of Life, Toxicity and Response Rate to First-line Chemotherapy in Patients With Advanced Lung Cancer
Background: A frequent manifestation of advanced lung cancer is malnutrition, timely
identification and treatment of which can lead to improved patient quality of life, response
rate to chemotherapy and survival. N-3 fatty acids, especially eicosapentaenoic acid (EPA)
and docosahexaenoic acid (DHA), may possess anticachectic properties. This trial compared a
protein and energy dense supplement enriched with n-3 fatty acids with nutritional
assessment for their effects on weight, lean body mass (LBM), body fat, phase angle, dietary
intake, inflammatory response and quality of life in first-line chemotherapy patients with
advanced lung cancer.
Hypothesis: Lung cancer patients who received EPA and DHA containing oral supplement will
have a lower frequency of weight loss, rate of adverse effects to chemotherapy and
inflammatory response, improving quality of life, response rate to chemotherapy compared
with patients who received nutritional assessment.
Methods: Chemonaive patients with stages IIIB and IV of lung cancer are going to receive
Paclitaxel and Cisplatin. Patients will be randomized to receive two cans/day of EPA and DHA
containing oral supplement or nutritional assessment one week prior to treatment until
completing two cycles. Serum levels of Reactive C Protein (RCP), interleukin-6 (IL-6) and
tumor necrosis factor alpha (TNF-alpha) are going to be measured baseline and after two
courses of chemotherapy. Phase angle and body composition will be measured using
Bioimpedance analysis (BIA). Quality of life, dietary intake will be assessed with validate
questionnaires. All data is going to be collected in a database for further blind analysis.
Written informed consent will be collected from all patients.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
Oscar Arrieta, MD
National Institute of Cancerología
Mexico: Scientific and Bioethic Committees of National Institute of Cancerologia