Primary Lung CancerPhase 2PPI-PROTECTNCT07076914
Prophylactic Proton Pump Inhibition for Esophageal Protection in Lung Radiation Therapy
A Phase 2 study testing Experimental (Health Canada Approved Proton Pump Inhibitors) in people with Primary Lung Cancer and Non Small Cell Lung Cancer, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
A randomized controlled trial to assess the impact of prophylactic proton pump inhibitor use to improve esophagitis in lung cancer patients undergoing radiation. Patients will be randomized into a standard of care arm or the prophylactic proton pump (daily) arm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Lung Cancer, Non Small Cell Lung Cancer, Small Cell Lung Cancer
- What is being tested?
- Experimental (Health Canada Approved Proton Pump Inhibitors)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteCanada
- Study dates
- 2 Oct 2025to 2 Oct 2032
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Age 18 years or older
- Willing to provide informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status 0-3
- Life expectancy of at least 3 months
- Primary lung malignancy of any stage (including NSCLC and small cell lung cancer). Histologic/pathologic diagnosis is preferred, but not required.
- Receiving a prescribed dose of at least 40 Gy in 15 fractions (or equivalent). Eligible fractionations include, but are not limited to, 60 Gy in 30 fractions, 55 Gy in 20 fractions, and 40-45 Gy in 15 fractions.
- On radiation planning, at least 5 cc of esophagus is receiving at least 95% of prescription dose
Who cannot join
- • Serious medical comorbidities precluding radiotherapy
- Use of PPI within 3 months prior to enrollment
- Allergy to PPI
- Odynophagia (painful swallowing) prior to enrollment
- Pregnant or lactating women
- Note: previous radiation to the thorax is allowed, as long as the composite plan of current and prior radiation doses meet standard institutional dose constraints, in the opinion of the treating radiation oncologist.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prophylactic Proton Pump Inhibition for Esophageal Protection in Lung Radiation Therapy: A Randomized Clinical Trial
A randomized controlled trial to assess the impact of prophylactic proton pump inhibitor use to improve esophagitis in lung cancer patients undergoing radiation. Patients will be randomized into a standard of care arm or the prophylactic proton pump (daily) arm.
- Being tested
- Experimental (Health Canada Approved Proton Pump Inhibitors)
- Keywords
- proton pump inhibitor, lung cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental (Health Canada Approved Proton Pump Inhibitors)Drug
Also called Proton Pump Inhibitor, Pantoprazole magnesium, rabeprazole
The intervention uses a proton pump inhibitor as a preventative measure
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Radiation delivered as per standard institutional approaches |
| Prophylactic Proton Pump Inhibitor | Experimental | Daily use of pantoprazole magnesium, rabeprazole or lansoprazole Receives: Drug: Experimental (Health Canada Approved Proton Pump Inhibitors) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Worst patient-reported esophageal pain score during radiation
Assessed with the 11-Numeric Rating Scale using weekly questionnaires
Measured: baseline last week of radiation post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start2 Oct 2025 (estimated)
- Primary completion2 Jan 2028 (estimated)
- Study completion2 Oct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Lung CancerStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Palma, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07076914
- Sponsor's protocol ID
- PPI-PROTECT
- Acronym
- PPI-PROTECT
- Status last verified
- Jul 2025
- First submitted
- 3 Jul 2025
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Proton Pump Inhibition for Esophageal Protection in Lung Radiation Therapy: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07076914
- Acronym / sponsor ID
- PPI-PROTECT / PPI-PROTECT
- Keywords
- proton pump inhibitor, lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 2 Oct 2025 (estimated)
- Primary completion
- 2 Jan 2028 (estimated)
- Study completion
- 2 Oct 2032 (estimated)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized controlled trial to assess the impact of prophylactic proton pump inhibitor use to improve esophagitis in lung cancer patients undergoing radiation. Patients will be randomized into a standard of care arm or the prophylactic proton pump (daily) arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Radiation delivered as per standard institutional approaches |
| Prophylactic Proton Pump Inhibitor | Experimental | Drug: Experimental (Health Canada Approved Proton Pump Inhibitors)Daily use of pantoprazole magnesium, rabeprazole or lansoprazole |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 years or older
Key exclusion criteria (6 listed)
- • Serious medical comorbidities precluding radiotherapy
- Note: previous radiation to the thorax is allowed, as long as the composite plan of current and prior radiation doses meet standard institutional dose constraints, in the opinion of the treating radiation oncologist.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental (Health Canada Approved Proton Pump Inhibitors)Also: Proton Pump Inhibitor, Pantoprazole magnesium, rabeprazoleThe intervention uses a proton pump inhibitor as a preventative measure | Drug | Prophylactic Proton Pump Inhibitor |
Primary outcome
Worst patient-reported esophageal pain score during radiation
Time frame: baseline last week of radiation post-treatment
Assessed with the 11-Numeric Rating Scale using weekly questionnaires
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Experimental (Health Canada Approved Proton Pump Inhibitors) in people with Primary Lung Cancer and Non Small Cell Lung Cancer, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Palma (519-685-8650, David.Palma@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Worst patient-reported esophageal pain score during radiation (time frame: baseline last week of radiation post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.