Pantoprazole Prophylaxis Against Delayed CINV for Patients Receiving Breast Cancer Chemotherapy

NCT03948477 | Completed Phase 2 DMC

• 1 other identifier: CTNZ-2017-01
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 10

Brief Summary

This study explores whether a commonly used medication called Pantoprazole can help prevent delayed nausea and vomiting from chemotherapy for early breast cancer. Delayed nausea, and occasionally vomiting, can occur after breast cancer chemotherapy, affecting quality of life. A potential cause of these delayed side effects is that the chemotherapy may cause stomach irritation. Pantoprazole is commonly used to treat stomach irritation by reducing stomach acid, which may in turn improve nausea and/or vomiting. Patients undergoing breast cancer chemotherapy before or after primary surgery will be invited to participate in the study. They will be asked how much nausea or vomiting they have with and without Pantoprazole from Day 2 until 5 after they receive chemotherapy. All participants will still receive all of the usual anti-sickness medications, which are very effective in preventing sickness in the first 24 hours after treatment, but not for delayed symptoms. Information from the study may lead to a change in practice with patients using Pantoprazole to reduce the risks of delayed nausea and vomiting.

Conditions

Oncology; Breast Cancer; Chemotherapy-induced Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

• Reduce the incidence of delayed CINV in patients receiving adjuvant or neoadjuvant breast cancer chemotherapy

  To determine whether Pantoprazole can reduce the incidence of delayed CINV in patients receiving adjuvant or neoadjuvant breast cancer chemotherapy (as measured on day 5 using the MASCC Antiemesis Tool (MAT) to assess nausea over days 2-5 of each chemotherapy cycle) as compared to placebo. Specifically, the primary endpoint will be the complete absence of both nausea and vomiting during days 2-5.

  Measured on day 5, after chemotherapy

Secondary Outcomes (7)

• Nausea MAT scores

  Days 2-5 following chemotherapy for cycle 1 and 2 (each cycle is either 14 or 21 days)

• Vomiting MAT scores

  Days 2-5 following chemotherapy for cycle 1 and 2 (each cycle is either 14 or 21 days)

• Heartburn improvement

  Days 2-5 following chemotherapy for cycle 1 and 2 (each cycle is either 14 or 21 days)

• Heartburn and Nausea scores

  Days 2-5 following chemotherapy for cycle 1 and 2 (each cycle is either 14 or 21 days), using a regression model, with allowance for a possible non-linear relationship.

• Use of breakthrough medications

  Days 2-5 following chemotherapy for cycle 1 and 2 (each cycle is either 14 or 21 days)

Other Outcomes (2)

• Effect of chemotherapy regimen impacts use of Pantoprazole in terms of delayed CINV

  Measured on day 5, after chemotherapy

• Cycle effect

  Cycle 1 to end of cycle 2 (each cycle is either 14 or 21 days)

Study Arms (2)

Pantoprazole/Placebo

OTHER

Participants will take one 40 mg capsule of Pantoprazole daily for 5 days at the beginning of cycle 1 then they will take one capsule of matched Placebo daily for 5 days at the beginning of cycle 2

Drug: Pantoprazole 40mg; Drug: Placebo

Placebo/Pantoprazole

OTHER

Participants will take one capsule of matched Placebo daily for 5 days at the beginning of cycle 1 then they will take one 40 mg capsule of Pantoprazole daily for 5 days at the beginning of cycle 2

Drug: Pantoprazole 40mg; Drug: Placebo

Interventions

Pantoprazole 40mg DRUG

Proton pump inhibitor, drug action is to irreversibly block the hydrogen-potassium adenosine triphosphatase enzyme system (the 'proton pump') of the gastric parietal cell. This reduces basal and stimulated gastric acid secretion therefore raising gastric pH.

Also known as: Apo-Pantoprazole

Pantoprazole/Placebo; Placebo/Pantoprazole

Placebo DRUG

Matched placebo

Pantoprazole/Placebo; Placebo/Pantoprazole

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women who are being considered for adjuvant or neoadjuvant chemotherapy with either FEC or AC or TC chemotherapy and have been deemed by their treating Oncologist as being fit for treatment. The scheduled length of each chemotherapy cycle must be 14-21 days.
• Age ≥18 years.
• Willing to comply with all study requirements, including treatment (being able to swallow tablets), timing and nature of required assessments.
• All patients must be able to speak and read in English to ensure consent is informed and documentation of patient-reported outcome measures can be adhered to.
• Signed, written informed consent.

You may not qualify if:

• Patients who are receiving therapy to reduce gastric acid (including proton pump Inhibitors (e.g. Omeprazole, Pantoprazole, Lansoprazole, Esomeprazole or Histamine type-2 receptor antagonists e.g. Ranitidine)) at the time of enrolment will be excluded from the trial.
• Patients with pre-existing hypomagnesemia as defined by the reference range at the investigating sites laboratory.
• Patients with a history of cardiac arrhythmias including atrial fibrillation or paroxysmal tachycardias.
• Patients with known metastatic disease.
• The presence of any serious medical or psychiatric conditions, which might limit the ability of the patient to comply with follow up.
• The presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow up schedule, including alcohol dependence or drug abuse.
• Pregnancy, lactation or inadequate contraception. Women must be postmenopausal, infertile, or use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration.

Sponsors & Collaborators

• University of Auckland, New Zealand: lead

Study Sites (10)

Auckland City Hospital

Auckland, New Zealand

Location

Christchurch Hospital

Christchurch, New Zealand

Location

Dunedin Hospital

Dunedin, New Zealand

Location

Waikato Hospital

Hamilton, New Zealand

Location

Taranaki Base Hospital

New Plymouth, New Zealand

Location

Palmerston North Hospital

Palmerston North, New Zealand

Location

Rotorua Hospital

Rotorua, 3010, New Zealand

Location

Tauranga Hospital

Tauranga, New Zealand

Location

Wellington Hospital

Wellington, New Zealand

Location

Whangarei Hospital

Whangarei, 0148, New Zealand

Location

Related Publications (1)

• Wewala N, Kim Y, Sharples K, Benge S, Cartwright R, Tan A, Clement L, Huang Y, Wilson S, Kuper-Hommel M, Barton S, Jones J, Bremer L, Hari Dass P, Wrigley A, Findlay M, Isaacs R. Proton pump inhibition to prevent delayed chemotherapy-induced nausea and vomiting in patients receiving adjuvant or neoadjuvant breast cancer chemotherapy: a phase II, randomised double-blind crossover trial (PantoCIN). Support Care Cancer. 2025 May 20;33(6):484. doi: 10.1007/s00520-025-09528-0.

  PMID: 40394328 DERIVED

Related Links

• Cancer Trials New Zealand website study record
• Breast Cancer Foundation website study record (Co-funder)

MeSH Terms

Conditions

Neoplasms; Breast Neoplasms; Vomiting

Interventions

Pantoprazole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Ricard Isaacs, MBChB FRACP

  Midcentral Regional Cancer Centre Services

  PRINCIPAL INVESTIGATOR

• Navin Wewala, MBChB FRACP

  Midcentral Regional Cancer Centre Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-blinded
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Oncologist

Model Details: Double-blinded, randomised, crossover trial, phase II, stratified by the chemotherapy regimen

Study Record Dates

• First Submitted: March 28, 2019
• First Posted: May 14, 2019
• Study Start: June 10, 2019
• Primary Completion: October 15, 2021
• Study Completion: October 15, 2021
• Last Updated: May 25, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (10)