Pantoprazole Prophylaxis Against Delayed CINV for Patients Receiving Breast Cancer Chemotherapy

• Status: Recruiting
• Trial end date: 2021-07-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Auckland, New Zealand
• Treatments: Pantoprazole

Criteria

Inclusion Criteria:

1. 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.

2. Age ≥18 years.

3. Willing to comply with all study requirements, including treatment (being able to swallow tablets), timing and nature of required assessments.

4. 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.

5. Signed, written informed consent.

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Exclusion Criteria:

1. 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.

2. Patients with pre-existing hypomagnesemia as defined by the reference range at the investigating sites laboratory.

3. Patients with a history of cardiac arrhythmias including atrial fibrillation or paroxysmal tachycardias.

4. Patients with known metastatic disease.

5. The presence of any serious medical or psychiatric conditions, which might limit the ability of the patient to comply with follow up.

6. 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.

7. 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.

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