Prophylactic Proton Pump Inhibition for Esophageal Protection in Lung Radiation Therapy (NCT07076914) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Prophylactic Proton Pump Inhibition for Esophageal Protection in Lung Radiation Therapy
Canada58 participantsStarted 2025-10-02
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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
Exclusion Criteria:
* ⢠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.
What they're measuring
1
Worst patient-reported esophageal pain score during radiation
Timeframe: baseline last week of radiation post-treatment
Trial details
NCT IDNCT07076914
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's