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Non Small Cell Lung CancerNCT05805319

Dietary Intervention for NSCLC Patients Treated With ICI

A study testing increasing total fiber intake in people with Non Small Cell Lung Cancer, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.

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Sites and contacts
Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
increasing total fiber intake
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteCanada
Study dates
27 Apr 2023to 30 Oct 2027
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Canada1 site, 1 recruiting
  • Centre hospitalier de l'Université de Montréal (CHUM)

    Montreal, Quebec, H2X 3E4

    Wiam Belkaid, PhD, 514-836-3273, wiam.belkaid.chum@ssss.gouv.qc.ca

    Arielle Elkrief, MD, 514-890-8000, arielle.elkrief.med@ssss.gouv.qc.ca

    Recruiting

Other trials in Canada

About this study

Official title: Randomized Dietary Intervention to Improve Fiber Intake in Patients With Non-small Cell Lung Cancer Treated With Immune Checkpoint Inhibitor Therapy

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.

Read the detailed description

Nutritionist-guided dietary intervention in patients with NSCLC treated with ICI can improve patients' fiber intake.

Intervention:

After 1:1 randomization, patients in the intervention arm will complete a dietary survey and be counselled on increasing their total fiber intake. Patients in the control arm will complete the dietary survey without dietary intervention or counselling from a dietician. Both the intervention and control groups will have dietary survey and 24-hour recall survey at baseline, at 6 weeks, and at 12 weeks relative to ICI initiation.

Details of Dietary Intervention: Nutritionists will perform a standard evaluation, which includes a nutritional assessment of the patient's current dietary intake. The intervention will follow Canada Food Guide's recommendations (https://food-guide.canada.ca) for healthy eating with the addition of personalized recommendations on how to increase foods rich in dietary fiber. Recommendations may include food substitutions to food equivalent options that are richer in fiber, such as exchanging low fiber white bread to whole wheat bread for an increase in 3g of fiber per slice. Recommendations may also include adding fiber-rich foods and Mediterranean meals or snacks, with a supporting document highlighting inexpensive options such as frozen vegetables and fruit, rolled oats, canned or dried pulses, whole wheat pasta or whole grain rice. Patients will receive a document that lists food sources of fiber as well as generalized recommendations on how to incorporate them into daily eating habits. They will be counselled how to read food labels to identify fiber content of packaged foods. On average, participants will be encouraged to choose or add foods richer in fiber to achieve 5-10 g of fiber per meal with snacks containing 3-5 g of fiber. They will not be asked to track the grams of fiber they eat, the nutritionist will measure their fiber intake and will adjust her recommendations in order to achieve 25 g of fiber or more. Although there is no tolerable upper limit set for fiber, the nutritional intervention will aim to avoid an excess fiber intake (60-70g) to prevent displacement of other nutrients and a negative impact on nutritional adequacy of the diet. The current recommended adequate intake of fiber set for adults is based on approximately >25 g per day. Participants will be encouraged to increase their fiber in a gradual step-wise manner (approximately 5-10 g maximum per day) to limit possible digestive side effects from too rapid of an introduction. For patients with diarrhea, a known possible side effect of immunotherapy, they will be advised to select food sources that are rich in soluble fiber rather than insoluble fibers.

Being tested
increasing total fiber intake
Keywords
Diet, Fiber Intake, Immune checkpoint inhibitor therapy, NSCLC, Lung Cancer
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • increasing total fiber intakeOther

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

Study groups in NCT05805319
Study groupRoleWhat they receive
Control GroupNo interventionPatients 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 GroupExperimentalPatients 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.
Receives: Other: increasing total fiber intake

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 12 weeks

Secondary outcomes (1)
  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).

    By assessing the change in global dietary habits as measured by the Panagiotakos MedDietScore.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2023
  2. Study start27 Apr 2023
  3. Primary completion30 Jan 2027 (estimated)
  4. Study completion30 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05805319
Sponsor's protocol ID
22.261
Status last verified
Oct 2026
First submitted
15 Feb 2023
Last updated
22 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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