Prophylactic Proton Pump Inhibition for Esophageal Protection in Lung Radiation Therapy

NCT07076914 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: PPI-PROTECT
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Primary Lung Cancer; Non Small Cell Lung Cancer; Small Cell Lung Cancer

Keywords

proton pump inhibitor; lung cancer

Outcome Measures

Primary Outcomes (1)

• Worst patient-reported esophageal pain score during radiation

  Assessed with the 11-Numeric Rating Scale using weekly questionnaires

  baseline last week of radiation post-treatment

Study Arms (2)

Standard of Care

NO INTERVENTION

Radiation delivered as per standard institutional approaches

Prophylactic Proton Pump Inhibitor

EXPERIMENTAL

Daily use of pantoprazole magnesium, rabeprazole or lansoprazole

Drug: Experimental (Health Canada Approved Proton Pump Inhibitors)

Interventions

Experimental (Health Canada Approved Proton Pump Inhibitors) DRUG

The intervention uses a proton pump inhibitor as a preventative measure

Also known as: Proton Pump Inhibitor, Pantoprazole magnesium, rabeprazole

Prophylactic Proton Pump Inhibitor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A5W9, Canada

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma; Lung Neoplasms

Interventions

Proton Pump Inhibitors; Rabeprazole

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

David Palma

CONTACT

519-685-8650; David.Palma@lhsc.on.ca

Chris Goodman

CONTACT

519-685-8650; Chris.Goodman@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 22, 2025
• Study Start: October 2, 2025
• Primary Completion (Estimated): January 2, 2028
• Study Completion (Estimated): October 2, 2032
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)