Proton Pump Inhibitors for Lung Cancer
(PPI-PROTECT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether proton pump inhibitors (medications that reduce stomach acid) can prevent esophagitis (painful swelling of the esophagus) in lung cancer patients receiving radiation therapy. Participants will either take one of these medications daily or follow the usual care plan without it. The trial seeks to determine if the medication can ease the impact of radiation treatment on the esophagus. Individuals with a primary lung cancer diagnosis who are undergoing radiation therapy and have not used these medications in the past three months might be suitable candidates. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I need to stop my current medications for this trial?
The trial does not specify if you need to stop taking your current medications, but you cannot have used proton pump inhibitors (PPIs) in the 3 months before joining. It's best to discuss your current medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that proton pump inhibitors (PPIs) are usually well-tolerated for treating acid-related issues. Medications such as pantoprazole, rabeprazole, and lansoprazole are common and generally safe for short-term use. However, some studies suggest that long-term PPI use might increase certain health risks. For example, reports link extended PPI use to a higher cancer risk, mainly when used for more than three months.
In the case of lung cancer, using PPIs with some cancer treatments might affect treatment efficacy. However, for short-term use, especially in a controlled setting like a clinical trial, PPIs have a strong safety record. It's important to note that these findings mostly come from studies on long-term use, not the shorter periods typical in clinical trials. Researchers closely monitor participants to quickly manage any potential side effects.12345Why do researchers think this study treatment might be promising for lung cancer?
Unlike the standard treatments for lung cancer, which typically include chemotherapy, radiation, and targeted therapies, proton pump inhibitors (PPIs) like pantoprazole magnesium, rabeprazole, or lansoprazole offer a novel approach. These PPIs are usually used to reduce stomach acid, but researchers are exploring their potential to enhance cancer treatment by affecting the tumor microenvironment. Such a mechanism could make cancer cells more susceptible to traditional therapies, potentially improving outcomes without the harsh side effects often associated with chemotherapy and radiation. This innovative angle is what excites researchers, as it could lead to better, more tolerable treatment options for lung cancer patients.
What evidence suggests that proton pump inhibitors might be an effective treatment for esophagitis in lung cancer patients?
This trial will compare the effects of prophylactic Proton Pump Inhibitors (PPIs) with standard care in lung cancer patients undergoing radiation therapy. Research has shown that PPIs, commonly used to reduce stomach acid, might affect lung cancer patients, but results are mixed. Some studies suggest that PPIs could reduce the effectiveness of certain cancer treatments, like immune checkpoint inhibitors (ICIs), possibly lowering survival rates. There isn't enough evidence to clearly understand how PPIs impact radiation therapy, which this trial aims to study. While PPIs are generally safe for treating stomach issues, scientists continue to explore their role in cancer treatment.678910
Are You a Good Fit for This Trial?
This trial is for lung cancer patients undergoing radiation therapy who may benefit from a daily proton pump inhibitor to prevent esophagitis, an inflammation of the esophagus. Specific eligibility details are not provided.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Radiation
Participants receive radiation therapy as per standard institutional approaches, with or without prophylactic proton pump inhibitors
Follow-up
Participants are monitored for esophageal pain and other side effects post-treatment
What Are the Treatments Tested in This Trial?
Interventions
- Proton Pump Inhibitors
Trial Overview
The study tests if taking a Health Canada approved proton pump inhibitor every day can protect the esophagus during lung cancer radiation treatment compared to standard care without this preventive measure.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Daily use of pantoprazole magnesium, rabeprazole or lansoprazole
Radiation delivered as per standard institutional approaches
Find a Clinic Near You
Who Is Running the Clinical Trial?
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead Sponsor
Citations
Impact of Proton Pump Inhibitor Use on Progression-Free ...
PPIs were associated with decreased progression-free survival (PFS) and overall survival (OS) in NSCLC and melanoma patients receiving ICIs [13, ...
Five-year survival outcomes in NSCLC patients with ...
Emerging evidence suggests that proton pump inhibitors (PPIs) may impair ICI efficacy, potentially through gut microbiome and immune modulation.
EP11.03-22 Proton Pump Inhibitors' Impact on the ...
Recent literature has found PPI exposure to be a negative prognostic marker in ICI treatment. However, there is insufficient evidence to determine PPIs' impact ...
Association of proton pump inhibitor use with survival and ...
This study investigated the association of PPI use with survival and adverse effects in MM patients across three randomized-control trials.
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journals.lww.com
journals.lww.com/md-journal/fulltext/2022/09090/effect_of_proton_pump_inhibitors_on_the_clinical.25.aspxEffect of proton pump inhibitors on the clinical outcomes...
PPI use increased the risk of death by 43% (HR = 1.43, 95% CI 1.32–1.56) in solid cancer patients receiving PD-1/PD-L1 inhibitors (Fig. 1).
Proton Pump Inhibitors and Cancer Risk - PubMed Central - NIH
Results: Our review indicates that prolonged PPI use (exceeding three months) is significantly associated with an elevated risk of cancer, while ...
Proton Pump Inhibitor Use and Its Association with Lung ...
Results: Overall, PPI use was modestly associated, with a 19% increased likelihood of lung cancer occurrence (95% confidence intervals (CI): ...
The association between proton pump inhibitor use and ...
Concurrent proton-pump inhibitors increase risk of death for lung cancer patients receiving 1st-line gefitinib treatment—a nationwide ...
A pharmacovigilance study of the association between ...
Background: Proton pump inhibitors (PPIs) are effective treatments for acid-related disorders but may pose tumor risks with long-term use.
Proton pump inhibitors and cancer treatments
Proton pump inhibitors (PPIs) are widely used in cancer patients despite accumulating data showing that they can impact the efficacy of major anticancer drugs.
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