Prophylactic Proton Pump Inhibition for Esophageal Protection in Lung Radiation Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Experimental (Health Canada Approved Proton Pump Inhibitors).
- Who it may be relevant to
- Registry conditions: Primary Lung Cancer, Non Small Cell Lung Cancer, Small Cell Lung Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prophylactic Proton Pump Inhibition for Esophageal Protection in Lung Radiation Therapy: A Randomized Clinical Trial
Overview
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.
Interventions
- Drug Experimental (Health Canada Approved Proton Pump Inhibitors)
The intervention uses a proton pump inhibitor as a preventative measure
Primary outcome measures
- Worst patient-reported esophageal pain score during radiation [Time frame: baseline last week of radiation post-treatment]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- London Health Sciences Centre — London
Identifiers
NCT: NCT07076914 · PPI-PROTECT