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NCT Number: NCT07076914

Prophylactic Proton Pump Inhibition for Esophageal Protection in Lung Radiation Therapy

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.

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Key information

Conditions

Primary Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Non Small Cell Lung Cancer Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Cancer Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

London Health Sciences Centre

London, Ontario, N6A5W9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Experimental (Health Canada Approved Proton Pump Inhibitors)

Drug

The intervention uses a proton pump inhibitor as a preventative measure

Other names: Proton Pump Inhibitor, Pantoprazole magnesium, rabeprazole

Primary outcomes

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

Study contacts

Contact information is provided by the study sponsor or research team.

Chris Goodman

CONTACT

[email protected]

519-685-8650

David Palma

CONTACT

[email protected]

519-685-8650

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Registry information

Official study title

Prophylactic Proton Pump Inhibition for Esophageal Protection in Lung Radiation Therapy: A Randomized Clinical Trial

Acronym: PPI-PROTECT

Important dates

Study start: 2025
Primary completion: 2028
Study completion: 2032
First posted: Jul 22, 2025
Registry last updated: Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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