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

Sponsor

National Institute of Cancerología (Other)

Overall Status

Unknown status

CT.gov ID

NCT01048970

Collaborator

Abbott (Industry)

120

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

4.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Other: Nutritional Assessment Dietary Supplement: EPA-DHA arm	Phase 2/Phase 3

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Oct 1, 2009

Anticipated Primary Completion Date :

May 1, 2010

Anticipated Study Completion Date :

Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Other: Control arm Patients will receive nutritional assessment one week prior to treatment until completing two cycles	Other: Nutritional Assessment Patients will receive nutritional assessment one week prior to treatment until completing two courses of chemotherapy
Experimental: EPA-DHA arm 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 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

Arm

Intervention/Treatment

Other: Control arm

Patients will receive nutritional assessment one week prior to treatment until completing two cycles

Other: Nutritional Assessment

Patients will receive nutritional assessment one week prior to treatment until completing two courses of chemotherapy

Experimental: EPA-DHA arm

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

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

Outcome Measures

Primary Outcome Measures

Inflammatory response [12 months]
Response rate to chemotherapy [1 year]
Quality of life [1 year]
Nutritional status [1 year]

Secondary Outcome Measures

Overall survival [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.