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

NCT04175769 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2025-06-27

No results posted yet for this 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

Conditions

Interventions

DIETARY_SUPPLEMENT

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.

OTHER

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.

Sponsors & Collaborators

  • AHS Cancer Control Alberta

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-19
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04175769 on ClinicalTrials.gov