πŸ›οΈ Verified NIH Record β€’ Updated 2025-06-24

A Nutritional Supplement to Support People With Non-small Cell Lung Cancer (NCT04175769)

Exploring the Effects of a Nutritional Supplement During Immunotherapy or Combination of Immunotherapy and Chemotherapy in Non-small Cell Lung Cancer Patients

πŸ”΅ Active, Not Recruiting Observational / Diagnostic πŸ“‹ Clinical Research Protocol Sponsor: AHS Cancer Control Alberta

🩺 Plain-English Summary (8th-Grade Level)

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 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 immunotherapy or combination of immunotherapy and chemotherapy plus the experimental intervention nutritional product. Group 2 (Non-experimental intervention): standard intervention of immunotherapy or combination of immunotherapy and chemotherapy plus the non-experimental intervention placebo product. Participants will take 5 capsules each day by mouth, starting on the first day of immunotherapy with or without chemotherapy and stopping upon completion of their immunotherapy with or without 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

Who can join: Review the eligibility criteria below.

Location: Cross Cancer Institute β€” Edmonton, Alberta

Age range: 18 Years

πŸ§ͺ Interventions in This Study

πŸ“‹ "Do I Qualify?" β€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria β†—

πŸ“ All Participating Trial Locations (1 Sites)

  • Cross Cancer Institute β€” Edmonton, Alberta

πŸ’° Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA Β§ 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

πŸ’‘ How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
πŸ›οΈ View Official NIH Record β†—