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Completed

NCT Number: NCT04874935

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Faculty of Pharmacy

Tanta, 32511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lansoprazole

Drug

administration of lansoprazole 60 mg twice daily 4 days before starting neoadjuvant chemotherapy regimen and continue till end of chemotherapy cycles

Placebo

Drug

administration of Placebo capsule twice daily 4 days before starting neoadjuvant chemotherapy regimen and continue till end of chemotherapy cycles

Primary outcomes

  1. Tumor Response

    Time frame: 6 months

    • Tumor response evaluation will be assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  2. Change in ki67 level

    Time frame: baseline and end of neoadjuvant chemotherapy cycles each cycle will be repeated every 21 days or may postponed according to patient condition and doctor instructions.

    • Assessment of the level of Ki-67 expression in cancer cells through a staining process (a marker of cancer cell proliferation).
  3. Change in P-gp level

    Time frame: baseline and end of neoadjuvant chemotherapy cycles each cycle will be repeated every 21 days or may postponed according to patient condition and doctor instructions.

    • Assessment of P-gp level by ELISA Kits according to manufacturer's instructions.

Secondary outcomes

  1. Adverse events and toxicity

    Time frame: 6 months

    • Adverse events and toxicity will be graded using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.
  2. Follow up of kidney function

    Time frame: baseline and monthly through study completion, an average of 4 to 6 months

    measurement of serum creatinine levels in (mg/dl) and blood urea nitrogen (BUN) levels in (mg/dl) from blood samples will be assessed monthly for all participants.

  3. Follow up of liver function

    Time frame: baseline and monthly through study completion, an average of 4 to 6 months

    measurement of alanine transaminase (ALT) and aspartate transaminase (AST) both in U/L from blood samples will be assessed monthly for all participants.

  4. Follow up of complete blood count

    Time frame: baseline and monthly through study completion, an average of 4 to 6 months

    measurement of the counts of red blood cells, white blood cells, platelets, hemoglobin and hematocrit will be assessed monthly for all participants.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 6, 2021
Registry last updated
Nov 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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