A Nutritional Supplement to Support People With Non-small Cell Lung Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
Nutritional supplement: Subjects will orally consume two gelatin capsules of nutritional supplement (1 gram), 2 times per day with meals, and 1 capsule at one additional meal or snack, totaling five capsules per day beginning the first day of treatment and continuing for the duration of their treatment.
Placebo: Subjects will orally consume two gelatin capsules of placebo (1 gram), 2 times per day with meals, and 1 capsule at one additional meal or snack, totaling five capsules per day beginning the first day of treatment and continuing for the duration of their treatment.
Study 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 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
Eligibility
Primary outcome measure(s)
- Disease control rate — Upon completion of 4 cycles of treatment (each cycle is 21-days)
Disease control rate is defined as the sum of patients with a complete response, partial response or stable disease via RECIST v.1.1 or iRECIST after 4-cycles of immunotherapy or a combination of chemotherapy and immunotherapy.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Cross Cancer Institute | Edmonton | Alberta |
More AHS Cancer Control Alberta trials in Canada
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04175769 on ClinicalTrials.gov ↗ ← All trials in Canada