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

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.

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.

Study Overview

• Status: Unknown
• Conditions: Lung Cancer
• Intervention / Treatment: Other: Nutritional Assessment; Dietary supplement: EPA-DHA arm

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Mexico
  • Mexico City, Mexico, 14080
    • Recruiting
    • National Institute of Cancerología
    • Contact: Oscar Arrieta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival	1 year

Collaborators and Investigators

• Sponsor: National Institute of Cancerología
• Collaborators: Abbott
• Investigators: Principal Investigator: Oscar Arrieta, MD, National Institute of Cancerología

Publications and helpful links

General Publications

• Fearon KC, Von Meyenfeldt MF, Moses AG, Van Geenen R, Roy A, Gouma DJ, Giacosa A, Van Gossum A, Bauer J, Barber MD, Aaronson NK, Voss AC, Tisdale MJ. Effect of a protein and energy dense N-3 fatty acid enriched oral supplement on loss of weight and lean tissue in cancer cachexia: a randomised double blind trial. Gut. 2003 Oct;52(10):1479-86. doi: 10.1136/gut.52.10.1479.
• Gupta D, Lammersfeld CA, Vashi PG, King J, Dahlk SL, Grutsch JF, Lis CG. Bioelectrical impedance phase angle in clinical practice: implications for prognosis in stage IIIB and IV non-small cell lung cancer. BMC Cancer. 2009 Jan 28;9:37. doi: 10.1186/1471-2407-9-37.
• Dewey A, Baughan C, Dean T, Higgins B, Johnson I. Eicosapentaenoic acid (EPA, an omega-3 fatty acid from fish oils) for the treatment of cancer cachexia. Cochrane Database Syst Rev. 2007 Jan 24;2007(1):CD004597. doi: 10.1002/14651858.CD004597.pub2.
• Sanchez-Lara K, Turcott JG, Juarez-Hernandez E, Nunez-Valencia C, Villanueva G, Guevara P, De la Torre-Vallejo M, Mohar A, Arrieta O. Effects of an oral nutritional supplement containing eicosapentaenoic acid on nutritional and clinical outcomes in patients with advanced non-small cell lung cancer: randomised trial. Clin Nutr. 2014 Dec;33(6):1017-23. doi: 10.1016/j.clnu.2014.03.006. Epub 2014 Apr 4.

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (ANTICIPATED): May 1, 2010
• Study Completion (ANTICIPATED): December 1, 2010

Study Registration Dates

• First Submitted: January 9, 2010
• First Submitted That Met QC Criteria: January 12, 2010
• First Posted (ESTIMATE): January 14, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): January 14, 2010
• Last Update Submitted That Met QC Criteria: January 12, 2010
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Keywords: Lung cancer; Weight loss; Body composition; Toxicity; Inflammatory response; Eicosapentaenoic acid oral supplementation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: INCAN/CC/330/09; CA171/CB/558/09 (OTHER: National Institute of Cancerologia)