Dietary Intervention for NSCLC Patients Treated With ICI

NCT05805319 | Recruiting

• 1 other identifier: 22.261
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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).

  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).

  12 weeks

Secondary Outcomes (1)

• Proportion of patients in the intervention arm (nutritionist intervention) with improved Panagiotakos MedDietScore (defined by a score higher than 26.25 on 55 or an increase of 10 points)) compared to the control arm (no nutritionist intervention).

  12 weeks

Study Arms (2)

Control Group

NO INTERVENTION

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.

Intervention Group

EXPERIMENTAL

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.

Other: increasing total fiber intake

Interventions

increasing total fiber intake OTHER

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

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 3E4, Canada

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Bertrand Routy, MD,PhD

  CHUM

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wiam Belkaid, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: April 10, 2023
• Study Start: April 27, 2023
• Primary Completion: March 30, 2025
• Study Completion: March 30, 2026
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)