The Possible Efficacy and Safety of Lansoprazole Co-administration With Neoadjuvant Chemotherapy in Women With Breast Cancer

Tanta University

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Drug: Lansoprazole; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04874935

34615/4/21

Details and patient eligibility

About

Investigation of the possible efficacy and safety of lansoprazole co-administration with neoadjuvant chemotherapy in tumor response in women with breast cancer who will be planned for surgery.

Full description

Several studies revealed that PPIs inhibit not only the H+/K+ ATPase in gastric parietal cells, but also the vacuolar H+ ATPase (V-ATPase) overexpressed in tumor cells, the V-ATPase is an ATP-dependent proton pump that transports H+ across both intracellular and plasma membranes to regulate intracellular and extracellular pH.

Co-administration or pretreatment with PPIs could inhibit H+ transport via the V-ATPase in tumor cells, resulting in lower extracellular acidification and intracellular acidic vesicles which increase the sensitivity of the tumor cells to the anticancer agents. Moreover, the low extracellular pH induces an increased activity of drug efflux pumps P-glycoprotein (P-gp), which is closely associated with multi-drug resistance (MDR) of tumors. As a consequence, there remains a lower concentration of chemotherapeutic drugs in tumor cells and reduced cytotoxic efficacy, thus restoring the normal extracellular PH will decrease MDR.

Enrollment: 66 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Females with age ≥ 18 years old.
• Newly diagnosed breast cancer patients.
• Planned neoadjuvant chemotherapy.

Exclusion criteria

• Pregnancy.
• Nursing mothers.
• Active or uncontrolled infection.
• Presence of another malignancies.
• Inadequate blood picture.
• Serum Creatinine more than 1.5 mg /dl.
• AST and ALT more than 2.5 upper limit.
• History of known hypersensitivity to lansoprazole.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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66 participants in 2 patient groups, including a placebo group

Lansoprazole arm

Active Comparator group

Description:

33 patients who will receive neoadjuvant chemotherapy and lansoprazole 60 mg twice daily four days before starting chemotherapy regimen and then the same dose will be used during chemotherapy cycles

Treatment:

Drug: Lansoprazole

Placebo arm

Placebo Comparator group

Description:

33 patients who will receive neoadjuvant chemotherapy and placebo capsules.

Treatment:

Drug: Placebo