Effect on the Nutritional and Inflammatory Status of Docosahexaenoic Acid (DHA) and Eicosapentaenoic Acid (EPA)- Containing Supplement in Patients With Advanced Lung Cancer

Study Overview
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Brief Summary
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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. 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.

Detailed Description
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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.

Official Title
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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

Conditions
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Lung Cancer

Intervention / Treatment
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* Other: Nutritional Assessment
* Dietary Supplement: EPA-DHA arm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histopathology diagnosis of stage IIIB or IV lung cancer. Patients who will received paclitaxel 175 mg/m2 and cisplatin 75 mg/m2 chemotherapy treatment each 3 weeks. ECOG < 2. Hepatic, nephrotic and hematology laboratories in normal ranges. Exclusion Criteria: Patients who do not accept to participate. Patients who have been received chemotherapy treatment. Patients with current nutritional assessment and/or nutritional supplements intake. Patients with poor performance status. Pregnant or lactating women.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control arm<br>Patients will receive nutritional assessment one week prior to treatment until completing two cycles | Other: Nutritional Assessment<br>* Patients will receive nutritional assessment one week prior to treatment until completing two courses of chemotherapy<br>|
| Experimental: EPA-DHA arm<br>Patients will be randomized to receive two cans/day of EPA and DHA containing oral supplement one week prior to treatment until completing two courses of chemotherapy | Dietary Supplement: EPA-DHA arm<br>* Patients will be randomized to receive two cans/day of EPA and DHA containing oral supplement one week prior to treatment until completing two courses of chemotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory response |  | 12 months | 
| Response rate to chemotherapy |  | 1 year | 
| Quality of life |  | 1 year | 
| Nutritional status |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung cancer, Eicosapentaenoic acid oral supplementation, Weight loss, Toxicity, Body composition, Inflammatory response