Prophylactic Proton Pump Inhibition for Esophageal Protection in Lung Radiation Therapy (PPI-PROTECT)

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

Status and phase

Not yet enrolling

Phase 2

Conditions

Small Cell Lung Cancer

Non Small Cell Lung Cancer

Primary Lung Cancer

Treatments

Drug: Experimental (Health Canada Approved Proton Pump Inhibitors)

Study type

Interventional

Funder types

Other

Identifiers

NCT07076914

PPI-PROTECT

Details and patient eligibility

About

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.

Enrollment

58 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.