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.
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
- 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
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.
- Conditions
- Non Small Cell Lung Cancer
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: increasing total fiber intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted10 Apr 2023
- Study start27 Apr 2023
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bertrand Routy, MD,PhD, Principal investigator, CHUM
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