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

Sponsor
Tanta University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04874935
Collaborator
(none)
66
Enrollment
1
Location
2
Arms
17.7
Anticipated Duration (Months)
3.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
The Possible Efficacy and Safety of Lansoprazole Co-administration With Neoadjuvant Chemotherapy in Women With Breast Cancer
Actual Study Start Date :
Jun 10, 2021
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Lansoprazole arm

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

Drug: Lansoprazole
administration of lansoprazole 60 mg twice daily 4 days before starting neoadjuvant chemotherapy regimen and continue till end of chemotherapy cycles
Placebo Comparator: Placebo arm

33 patients who will receive neoadjuvant chemotherapy and placebo capsules.

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

Outcome Measures

Primary Outcome Measures

  1. Tumor Response [6 months]

    - Tumor response evaluation will be assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

  2. Change in ki67 level [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 [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 Outcome Measures

  1. Adverse events and toxicity [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Pharmacy Tanta Egypt 32511

Sponsors and Collaborators

  • Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Samah Hussein Mohamed, Principal investigator, Tanta University
ClinicalTrials.gov Identifier:
NCT04874935
Other Study ID Numbers:
  • 34615/4/21
First Posted:
May 6, 2021
Last Update Posted:
Nov 2, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Breast Neoplasms
Lansoprazole
Dexlansoprazole

Study Results

No Results Posted as of Nov 2, 2021