EPA+DHA for Non-small Cell Lung Cancer Patients.

Official Title

Improving the Clinical Benefit of Chemotherapy, Immunotherapy or Combination of Immunotherapy and Chemotherapy With Omega-3 Fatty Acid Supplementation in Non-small Cell Lung Cancer Patients.

Summary:

People with non-small cell lung cancer are at risk for nutritional deficiencies. The purpose of this study is to find out what effects a nutritional product has on patient's response to immunotherapy and chemotherapy or combination of immunotherapy and chemotherapy. To do this, some of the participants will get the nutritional product and some will receive a placebo (a substance that looks like the study drug but does not have any active or medicinal ingredients). A placebo is used to make the results of the study more reliable. Participants will be randomized to any of the following treatment groups: - Group 1 (Experimental intervention): standard intervention of chemotherapy, immunotherapy or combination of immunotherapy and chemotherapy plus the experimental intervention nutritional product. Group 2 (Non-experimental intervention): standard intervention of chemotherapy, immunotherapy or combination of immunotherapy and chemotherapy plus the non-experimental intervention placebo product. Participants will take 4 capsules each day by mouth, starting on the first day of chemotherapy and stopping upon completion of chemotherapy treatment. Participants will complete a diary of their nutritional/ placebo product intake and will undergo the following assessments: - Physical examination. - Height and weight. - ECOG status (the physician will record the impact on the cancer on daily living abilities). - Concomitant medications recording. - Adverse Event Assessment - Computed tomography (CT) scan. A series of x-rays of the body from many angles that are turned into 3-dimensional pictures on a screen. - Quality of life questionnaires. - Blood collection

Trial Description

Primary Outcome:

  • Disease control rate
Secondary Outcome:
  • Progression-free survival
  • 1-year survival
  • Chemotherapy-induced toxicities
  • Change in skeletal muscle mass and adipose tissue
  • Change in Serum CRP
  • Change in Serum Albumin
  • Change in Fatty Acid Incorporation and Omega-3 Index
  • Changes in Quality of Life
  • Changes in Quality of Life
  • Changes in Quality of Life
  • Changes in Quality of Life

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society