Effect on the Nutritional and Inflammatory Status of Docosahexaenoic Acid (DHA) and Eicosapentaenoic Acid (EPA)- Containing Supplement in Patients With Advanced Lung Cancer
NCT ID: NCT01048970
Last Updated: 2010-01-14
Study Results
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Basic Information
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UNKNOWN
PHASE2/PHASE3
120 participants
INTERVENTIONAL
2009-10-31
2010-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Control arm
Patients will receive nutritional assessment one week prior to treatment until completing two cycles
Nutritional Assessment
Patients will receive nutritional assessment one week prior to treatment until completing two courses of chemotherapy
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
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
Interventions
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Nutritional Assessment
Patients will receive nutritional assessment one week prior to treatment until completing two courses of chemotherapy
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
Eligibility Criteria
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Inclusion Criteria
* 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 have been received chemotherapy treatment.
* Patients with current nutritional assessment and/or nutritional supplements intake.
* Patients with poor performance status.
* Pregnant or lactating women.
20 Years
75 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
National Institute of Cancerología
OTHER_GOV
Responsible Party
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National Institute of Cancerologia
Principal Investigators
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Oscar Arrieta, MD
Role: PRINCIPAL_INVESTIGATOR
National Institute of Cancerología
Locations
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National Institute of Cancerologia
Mexico City, Mexico City, Mexico
National Institute of Cancerología
Mexico City, Mexico City, Mexico
Countries
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Central Contacts
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Facility Contacts
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Oscar Arrieta
Role: primary
References
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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.
Other Identifiers
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CA171/CB/558/09
Identifier Type: OTHER
Identifier Source: secondary_id
INCAN/CC/330/09
Identifier Type: -
Identifier Source: org_study_id
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