Randomized Dietary Intervention to Improve Fiber Intake in Patients With Non-small Cell Lung Cancer Treated With Immune Checkpoint Inhibitor Therapy
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This is a single-center randomized trial in patients with non-small cell lung cancer (NSCLC) treated with immune checkpoint inhibition. Patients will receive standard-of-care immune checkpoint inhibitor (ICI) therapy alone or in combination with a dietary intervention.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Canada
Centre hospitalier de l'Université de Montréal (CHUM)
RECRUITING
Montreal
Contact Information
Primary
Wiam Belkaid, PhD
wiam.belkaid.chum@ssss.gouv.qc.ca
514-890-8000
Time Frame
Start Date: 2023-04-27
Estimated Completion Date: 2026-03-30
Participants
Target number of participants: 80
Treatments
No_intervention: Control Group
Patients in the control arm will complete the dietary survey without dietary intervention or counselling from a dietician. Control group will have dietary survey and 24-hour recall survey at baseline, at 6 weeks, and at 12 weeks relative to ICI initiation.
Experimental: Intervention Group
Patients in the intervention arm will complete a dietary survey and be counselled on increasing their total fiber intake. Intervention group will have dietary survey and 24-hour recall survey at baseline, at 6 weeks, and at 12 weeks relative to ICI initiation.
Related Therapeutic Areas
Sponsors
Leads: Centre hospitalier de l'Université de Montréal (CHUM)