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Breast CancerPhase 3NCT04874935

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

A Phase 3 study testing Lansoprazole in people with Breast Cancer, run by Tanta University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
Lansoprazole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
66 participants
Where
1 siteEgypt
Study dates
10 Jun 2021to 5 Nov 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Egypt1 site

  • Faculty of Pharmacy

    Tanta, 32511

Other trials in Egypt

About this study

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.

Read the 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.

Conditions
Breast Cancer
Being tested
Lansoprazole, Placebo
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LansoprazoleDrug

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

  • PlaceboDrug

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

Study groups in NCT04874935
Study groupRoleWhat they receive
Lansoprazole armActive comparator33 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
Receives: Drug: Lansoprazole
Placebo armPlacebo comparator33 patients who will receive neoadjuvant chemotherapy and placebo capsules.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tumor Response

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

    Measured: 6 months

  2. Change in ki67 level

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

    Measured: 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.

  3. Change in P-gp level

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

    Measured: 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.

Secondary outcomes (4)

  1. Adverse events and toxicity

    • Adverse events and toxicity will be graded using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.

    Measured: 6 months

  2. Follow up of kidney function

    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.

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

  3. Follow up of liver function

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

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

  4. Follow up of complete blood count

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2021
  2. Study start10 Jun 2021
  3. Primary completion5 Nov 2022
  4. Study completion5 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04874935
Sponsor's protocol ID
34615/4/21
Status last verified
Oct 2022
First submitted
29 Apr 2021
Last updated
15 Nov 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Lee YY, Jeon HK, Hong JE, Cho YJ, Ryu JY, Choi JJ, Lee SH, Yoon G, Kim WY, Do IG, Kim MK, Kim TJ, Choi CH, Lee JW, Bae DS, Kim BG. Proton pump inhibitors enhance the effects of cytotoxic agents in chemoresistant epithelial ovarian carcinoma. Oncotarget. 2015 Oct 27;6(33):35040-50. doi: 10.18632/oncotarget.5319.

    PubMed 26418900

  • Whitton B, Okamoto H, Packham G, Crabb SJ. Vacuolar ATPase as a potential therapeutic target and mediator of treatment resistance in cancer. Cancer Med. 2018 Aug;7(8):3800-3811. doi: 10.1002/cam4.1594. Epub 2018 Jun 21.

    PubMed 29926527

  • Ikemura K, Hiramatsu S, Okuda M. Drug Repositioning of Proton Pump Inhibitors for Enhanced Efficacy and Safety of Cancer Chemotherapy. Front Pharmacol. 2017 Dec 12;8:911. doi: 10.3389/fphar.2017.00911. eCollection 2017.

    PubMed 29311921

  • Lu ZN, Tian B, Guo XL. Repositioning of proton pump inhibitors in cancer therapy. Cancer Chemother Pharmacol. 2017 Nov;80(5):925-937. doi: 10.1007/s00280-017-3426-2. Epub 2017 Aug 31.

    PubMed 28861639

  • Wang BY, Zhang J, Wang JL, Sun S, Wang ZH, Wang LP, Zhang QL, Lv FF, Cao EY, Shao ZM, Fais S, Hu XC. Intermittent high dose proton pump inhibitor enhances the antitumor effects of chemotherapy in metastatic breast cancer. J Exp Clin Cancer Res. 2015 Aug 22;34(1):85. doi: 10.1186/s13046-015-0194-x.

    PubMed 26297142

  • da Silva VP, Mesquita CB, Nunes JS, de Bem Prunes B, Rados PV, Visioli F. Effects of extracellular acidity on resistance to chemotherapy treatment: a systematic review. Med Oncol. 2018 Oct 30;35(12):161. doi: 10.1007/s12032-018-1214-4.

    PubMed 30377828

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lansoprazole in people with Breast Cancer, run by Tanta University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tumor Response (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04874935, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2022.

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