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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

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

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01048970
Enrollment
120
Registered
2010-01-14
Start date
2009-10-31
Completion date
2010-12-31
Last updated
2010-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

Lung cancer, Eicosapentaenoic acid oral supplementation, Weight loss, Toxicity, Body composition, Inflammatory response

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.

Interventions

OTHERNutritional Assessment

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

DIETARY_SUPPLEMENTEPA-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

Sponsors

Abbott
CollaboratorINDUSTRY
National Institute of Cancerología
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Nutritional status1 year
Inflammatory response12 months
Response rate to chemotherapy1 year
Quality of life1 year

Secondary

MeasureTime frame
Overall survival1 year

Countries

Mexico

Contacts

Primary ContactOscar Arrieta, MD
ogar@servidor.unam.mx(+52) (55) 5628-0400
Backup ContactKarla Sánchez, MsC
ksanchez@medicasur.org.mx(+52) (55) 5424-7200

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026