Recruiting

Dietary Intervention

Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Code:

NCT05805319

Conditions

Non Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

increasing total fiber intake

Study Details

Brief 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.

Conditions

Non Small Cell Lung Cancer

Study ID

NCT05805319

Start date

Apr 27, 2023

Status verified date

Aug, 2024

Completion date

Mar 30, 2026

Anticipated

Primary completion date

Mar 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

increasing total fiber intake

Patients in the intervention arm will complete a dietary survey and be counselled on increasing their total fiber intake.

Primary outcome measure

  • Proportion of patients in the intervention arm (nutritionist intervention) with total daily fiber intake of >=25g/day compared to the control arm (no nutritionist intervention). [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Wiam Belkaid, PhD

514-890-8000wiam.belkaid.chum@ssss.gouv.qc.ca

Locations

Centre hospitalier de l'Université de Montréal (CHUM)

Recruiting

Montréal, Quebec, Canada, H2X 3E4

Contacts

Wiam Belkaid, PhD

514-836-3273wiam.belkaid.chum@ssss.gouv.qc.ca

Arielle Elkrief, MD

514-890-8000arielle.elkrief.med@ssss.gouv.qc.ca

Principal Investigator:

Bertrand Routy, MD, PhD

More Information

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Last update posted

Aug 12, 2024

Last verified

Aug, 2024

Keywords

  • Diet
  • Fiber Intake
  • Immune checkpoint inhibitor therapy
  • NSCLC
  • Lung Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM) on 2024-08-12.