NCT01048970

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P75+ for phase_2 lung-cancer

Timeline
Completed

Started Oct 2009

Shorter than P25 for phase_2 lung-cancer

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 14, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

January 14, 2010

Status Verified

January 1, 2010

Enrollment Period

7 months

First QC Date

January 9, 2010

Last Update Submit

January 12, 2010

Conditions

Lung Cancer

Keywords

Lung cancerEicosapentaenoic acid oral supplementationWeight lossToxicityBody compositionInflammatory response

Outcome Measures

Primary Outcomes (4)

  • Inflammatory response

    12 months

  • Response rate to chemotherapy

    1 year

  • Quality of life

    1 year

  • Nutritional status

    1 year

Secondary Outcomes (1)

  • Overall survival

    1 year

Study Arms (2)

Control arm

OTHER

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

Other: Nutritional Assessment

EPA-DHA arm

EXPERIMENTAL

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

Interventions

Nutritional AssessmentOTHER

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

Control arm
EPA-DHA armDIETARY_SUPPLEMENT

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

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Institute of Cancerologia

Mexico City, Mexico City, 14080, Mexico

RECRUITING

National Institute of Cancerología

Mexico City, Mexico City, 14080, Mexico

RECRUITING

Related Publications (4)

  • 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.

    PMID: 12970142BACKGROUND

  • 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.

    PMID: 19175932BACKGROUND

  • 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.

    PMID: 17253515BACKGROUND

  • 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.

    PMID: 24746976DERIVED

MeSH Terms

Conditions

Lung NeoplasmsWeight Loss

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Oscar Arrieta, MD

    National Institute of Cancerología

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Oscar Arrieta, MD

CONTACT

(+52) (55) 5628-0400ogar@servidor.unam.mx

Karla Sánchez, MsC

CONTACT

(+52) (55) 5424-7200ksanchez@medicasur.org.mx

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

January 9, 2010

First Posted

January 14, 2010

Study Start

October 1, 2009

Primary Completion

May 1, 2010

Study Completion

December 1, 2010

Last Updated

January 14, 2010

Record last verified: 2010-01

Locations

ME(2)