NCT07076914Not yet recruitingPhase 2
Prophylactic Proton Pump Inhibition for Esophageal Protection in Lung Radiation Therapy
Prophylactic Proton Pump Inhibition for Esophageal Protection in Lung Radiation Therapy: A Randomized Clinical Trial
Source: ClinicalTrials.gov · Last updated 22 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 58 (estimated)
- First submitted
- 3 Jul 2025
- Start date
- 2 Oct 2025
- Primary completion date
- 2 Jan 2028
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Diseases
- Lung cancer
- NCT number
- NCT07076914
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 58
- From 2 Oct 2025 to the primary completion date, 2 Jan 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- • 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| London Health Sciences Centre Coordinator of this site? Confirm its status | London | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.