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High Fiber Diet for Lung Cancer

N/A

Recruiting

Led By Bertrand Routy, MD,PhD

Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 years or older

Confirmed histological diagnosis of non-small cell lung cancer (NSCLC); Treatment with standard-of-care ICI

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

Study Summary

This trial tests if adding a dietary intervention to standard ICI therapy helps treat NSCLC.

Who is the study for?

This trial is for adults over 18 with confirmed non-small cell lung cancer (NSCLC) who are being treated with standard immune checkpoint inhibitors and can eat solid foods. It's not suitable for those with severe dietary allergies or psychiatric/substance abuse issues that could affect participation.Check my eligibility

What is being tested?

The study is testing if increasing total fiber intake affects the effectiveness of standard immune therapy in NSCLC patients. Participants will either continue their normal diet or follow a high-fiber diet alongside their regular cancer treatment.See study design

What are the potential side effects?

While the trial primarily involves dietary changes, side effects may arise from the underlying immune therapy, including fatigue, skin reactions, inflammation-related symptoms, and potential digestive changes due to increased fiber.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have been diagnosed with non-small cell lung cancer and am treated with standard immune checkpoint inhibitors.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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).

Secondary outcome measures

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).

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention GroupExperimental Treatment1 Intervention

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.

Group II: Control GroupActive Control1 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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor

366 Previous Clinical Trials

129,557 Total Patients Enrolled

Bertrand Routy, MD,PhDPrincipal InvestigatorCHUM

Media Library

Intervention Group Clinical Trial Eligibility Overview. Trial Name: NCT05805319 — N/A

Non-Small Cell Lung Cancer Research Study Groups: Intervention Group, Control Group

Non-Small Cell Lung Cancer Clinical Trial 2023: Intervention Group Highlights & Side Effects. Trial Name: NCT05805319 — N/A

Intervention Group 2023 Treatment Timeline for Medical Study. Trial Name: NCT05805319 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the current enrollment criteria for this trial?

"According to the clinicaltrials.gov data, this particular trial is not admitting any new candidates. The study was initially proposed on May 31st 2023 and has since underwent its last edit on April 6th of the same year. However, there are other trials that still need volunteers - 2063 related studies for potential participants in total."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Dietary Intervention for NSCLC Patients Treated With ICI

2023. "Dietary Intervention for NSCLC Patients Treated With ICI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05805319.