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
π©Ί 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
π§ͺ Interventions in This Study
π "Do I Qualify?" β 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria β
π All Participating Trial Locations (1 Sites)
- Cross Cancer Institute β Edmonton, Alberta
π° 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.
More studies in Non-small Cell Lung Cancer
- Phase 1/2 Study of Silevertinib (BDTX-1535) in Patients With Glioblastoma or Non-Small Cell Lung Cancer With EGFR Mutations β Birmingham, Alabama
- Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR or HER2 Mutation (WU-KONG1) β La Jolla, California
- PhI/II Study of Amivantamab and Tepotinib Combo in MET-altered Non-small Cell Lung Cancer β Houston, Texas
- Study of JDQ443 in Comparison With Docetaxel in Participants With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer β Renton, Washington
- Osimertinib and Gefitinib in EGFR Inhibitor naΓ―ve Advanced EGFR Mutant Lung Cancer β Boston, Massachusetts
- Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer With or Without Actionable Genomic Alterations (TROPION-LUNG01) β Chandler, Arizona
Explore by condition: All Non-small Cell Lung Cancer clinical trials
π‘ How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.