Clinical trial · Interventional
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
NCT07076914CI-TRIAL-00092462PPI-PROTECTnot yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Primary Lung Cancer | Lung Neoplasm | PROBABILISTIC | 0.70 |
| Small Cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Experimental (Health Canada Approved Proton Pump Inhibitors) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Standard of Care
- description
- Radiation delivered as per standard institutional approaches
- type
- EXPERIMENTAL
- label
- Prophylactic Proton Pump Inhibitor
- description
- Daily use of pantoprazole magnesium, rabeprazole or lansoprazole
- interventionNames
- Drug: Experimental (Health Canada Approved Proton Pump Inhibitors)
Primary outcomes (1)
- measure
- Worst patient-reported esophageal pain score during radiation
- timeFrame
- baseline last week of radiation post-treatment
- description
- Assessed with the 11-Numeric Rating Scale using weekly questionnaires
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.