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Trial record 3 of 190 for:    Oral Cancer | ( Map: Mexico )

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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ClinicalTrials.gov Identifier: NCT01048970
Recruitment Status : Unknown
Verified January 2010 by National Institute of Cancerología.
Recruitment status was:  Recruiting
First Posted : January 14, 2010
Last Update Posted : January 14, 2010
Sponsor:
Collaborator:
Abbott
Information provided by:
National Institute of Cancerología

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:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 2009
Estimated Primary Completion Date : May 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Inflammatory response [ Time Frame: 12 months ]
  2. Response rate to chemotherapy [ Time Frame: 1 year ]
  3. Quality of life [ Time Frame: 1 year ]
  4. Nutritional status [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01048970


Contacts
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Contact: Oscar Arrieta, MD (+52) (55) 5628-0400 ext 832 ogar@servidor.unam.mx
Contact: Karla Sánchez, MsC (+52) (55) 5424-7200 ext 4216 ksanchez@medicasur.org.mx

Locations
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Mexico
National Institute of Cancerologia Recruiting
Mexico City, Mexico, 14080
Contact: Oscar Arrieta, MD    (+52) (55) 5628-0400 ext 832    ogar@servidor.unam.mx   
Contact: Karla Sanchez, MsC    (+52) (55) 5414-7200 ext 4216    ksanchez@medicasur.org.mx   
National Institute of Cancerología Recruiting
Mexico City, Mexico, 14080
Contact: Oscar Arrieta         
Sponsors and Collaborators
National Institute of Cancerología
Abbott
Investigators
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Principal Investigator: Oscar Arrieta, MD National Institute of Cancerología

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Oscar Arrieta, National Institute of Cancerologia
ClinicalTrials.gov Identifier: NCT01048970     History of Changes
Other Study ID Numbers: INCAN/CC/330/09
CA171/CB/558/09 ( Other Identifier: National Institute of Cancerologia )
First Posted: January 14, 2010    Key Record Dates
Last Update Posted: January 14, 2010
Last Verified: January 2010

Keywords provided by National Institute of Cancerología:
Lung cancer
Eicosapentaenoic acid oral supplementation
Weight loss
Toxicity
Body composition
Inflammatory response

Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases