Prophylactic Proton Pump Inhibition for Esophageal Protection in Lung Radiation Therapy

ConditionsPrimary Lung Cancer Non Small Cell Lung Cancer Small Cell Lung Cancer

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

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

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

• Serious medical comorbidities precluding radiotherapy

Use of PPI within 3 months prior to enrollment

Allergy to PPI

Odynophagia (painful swallowing) prior to enrollment

Trial design

Design model

Parallel

Treatments tested in this trial

Experimental (Health Canada Approved Proton Pump Inhibitors)
Drug
The intervention uses a proton pump inhibitor as a preventative measure

Treatment groups

58 Participants

are divided into 2 treatment groups

Group A: Standard of CareNo intervention 0 interventions

Group B: Prophylactic Proton Pump InhibitorExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Worst patient-reported esophageal pain score during radiation

Assessed with the 11-Numeric Rating Scale using weekly questionnaires

Time frame

baseline last week of radiation post-treatment

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: