Dietary intervention for lung cancer patients receiving immune therapy
Randomized Dietary Intervention to Improve Fiber Intake in Patients With Non-small Cell Lung Cancer Treated With Immune Checkpoint Inhibitor Therapy
NA · Centre hospitalier de l'Université de Montréal (CHUM) · NCT05805319
This study is testing if a special diet that increases fiber can help lung cancer patients feel better while they are receiving immune therapy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) (other) |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT05805319 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of a nutritionist-guided dietary intervention aimed at increasing fiber intake in patients with non-small cell lung cancer (NSCLC) who are undergoing treatment with immune checkpoint inhibitors (ICI). Participants will be randomly assigned to either receive standard ICI therapy alone or in combination with dietary counseling to enhance their fiber consumption. The study will assess dietary habits through surveys and 24-hour recall at baseline, 6 weeks, and 12 weeks after starting ICI treatment. The goal is to determine if improved nutrition can positively impact patient outcomes during cancer therapy.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of non-small cell lung cancer who are receiving standard immune checkpoint inhibitor therapy.
Not a fit: Patients with severe dietary allergies or those with psychiatric or substance abuse disorders that may hinder their participation will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could enhance the effectiveness of immune therapy in lung cancer patients by improving their nutritional status.
How similar studies have performed: While dietary interventions in cancer care are being explored, this specific approach combining fiber intake with immune therapy is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Signed, informed consent * Age 18 years or older * Confirmed histological diagnosis of non-small cell lung cancer (NSCLC); Treatment with standard-of-care ICI * Ability to eat solid foods Exclusion Criteria: * Severe dietary allergies (e.g. shellfish, nuts, seafood) * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
Where this trial is running
Montreal, Quebec
- Centre hospitalier de l'Université de Montréal (CHUM) — Montreal, Quebec, Canada (RECRUITING)
Study contacts
- Principal investigator: Bertrand Routy, MD,PhD — CHUM
- Study coordinator: Wiam Belkaid, PhD
- Email: wiam.belkaid.chum@ssss.gouv.qc.ca
- Phone: 514-890-8000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Non Small Cell Lung Cancer, Diet, Fiber Intake, Immune checkpoint inhibitor therapy, NSCLC, Lung Cancer