Non Small Cell Lung Cancer, Primary Lung Cancer, Small Cell Lung Cancer
Conditions
Keywords
proton pump inhibitor, lung cancer
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.
Interventions
DRUGExperimental (Health Canada Approved Proton Pump Inhibitors)
The intervention uses a proton pump inhibitor as a preventative measure
Sponsors
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Worst patient-reported esophageal pain score during radiation | baseline last week of radiation post-treatment | Assessed with the 11-Numeric Rating Scale using weekly questionnaires |
Countries
Canada
Contacts
Primary ContactDavid Palma
Backup ContactChris Goodman
Outcome results
None listed