Effect on the Nutritional and Inflammatory Status of Docosahexaenoic Acid (DHA) and Eicosapentaenoic Acid (EPA)- Containing Supplement in Patients With Advanced Lung Cancer
Primary Purpose
Lung Cancer
Status
Unknown status
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Nutritional Assessment
EPA-DHA arm
Sponsored by
About this trial
This is an interventional supportive care trial for Lung Cancer focused on measuring Lung cancer, Eicosapentaenoic acid oral supplementation, Weight loss, Toxicity, Body composition, Inflammatory response
Eligibility Criteria
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.
Sites / Locations
- National Institute of CancerologiaRecruiting
- National Institute of CancerologíaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Control arm
EPA-DHA arm
Arm Description
Patients will receive nutritional assessment one week prior to treatment until completing two cycles
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
Outcomes
Primary Outcome Measures
Inflammatory response
Response rate to chemotherapy
Quality of life
Nutritional status
Secondary Outcome Measures
Overall survival
Full Information
NCT ID
NCT01048970
First Posted
January 9, 2010
Last Updated
January 12, 2010
Sponsor
National Institute of Cancerología
Collaborators
Abbott
1. Study Identification
Unique Protocol Identification Number
NCT01048970
Brief Title
Effect on the Nutritional and Inflammatory Status of Docosahexaenoic Acid (DHA) and Eicosapentaenoic Acid (EPA)- Containing Supplement in Patients With Advanced Lung Cancer
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 Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Unknown status
Study Start Date
October 2009 (undefined)
Primary Completion Date
May 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Cancerología
Collaborators
Abbott
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Lung cancer, Eicosapentaenoic acid oral supplementation, Weight loss, Toxicity, Body composition, Inflammatory response
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control arm
Arm Type
Other
Arm Description
Patients will receive nutritional assessment one week prior to treatment until completing two cycles
Arm Title
EPA-DHA arm
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Nutritional Assessment
Intervention Description
Patients will receive nutritional assessment one week prior to treatment until completing two courses of chemotherapy
Intervention Type
Dietary Supplement
Intervention Name(s)
EPA-DHA arm
Intervention Description
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
Primary Outcome Measure Information:
Title
Inflammatory response
Time Frame
12 months
Title
Response rate to chemotherapy
Time Frame
1 year
Title
Quality of life
Time Frame
1 year
Title
Nutritional status
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oscar Arrieta, MD
Phone
(+52) (55) 5628-0400
Ext
832
Email
ogar@servidor.unam.mx
First Name & Middle Initial & Last Name or Official Title & Degree
Karla Sánchez, MsC
Phone
(+52) (55) 5424-7200
Ext
4216
Email
ksanchez@medicasur.org.mx
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oscar Arrieta, MD
Organizational Affiliation
National Institute of Cancerología
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institute of Cancerologia
City
Mexico City
ZIP/Postal Code
14080
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oscar Arrieta, MD
Phone
(+52) (55) 5628-0400
Ext
832
Email
ogar@servidor.unam.mx
First Name & Middle Initial & Last Name & Degree
Karla Sanchez, MsC
Phone
(+52) (55) 5414-7200
Ext
4216
Email
ksanchez@medicasur.org.mx
Facility Name
National Institute of Cancerología
City
Mexico City
ZIP/Postal Code
14080
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oscar Arrieta
12. IPD Sharing Statement
Citations:
PubMed Identifier
12970142
Citation
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.
Results Reference
background
PubMed Identifier
19175932
Citation
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.
Results Reference
background
PubMed Identifier
17253515
Citation
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.
Results Reference
background
PubMed Identifier
24746976
Citation
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.
Results Reference
derived
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Effect on the Nutritional and Inflammatory Status of Docosahexaenoic Acid (DHA) and Eicosapentaenoic Acid (EPA)- Containing Supplement in Patients With Advanced Lung Cancer
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