Pantoprazole Prophylaxis Against Delayed CINV for Patients Receiving Breast Cancer Chemotherapy

Last updated: May 23, 2022
Sponsor: University of Auckland, New Zealand
Overall Status: Completed

Phase

2

Condition

Effects Of Chemotherapy

Breast Cancer

Neoplasms

Treatment

N/A

Clinical Study ID

NCT03948477
CTNZ-2017-01
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria: 1. Men or women who are being considered for adjuvant or neoadjuvant chemotherapy witheither FEC or AC or TC chemotherapy and have been deemed by their treating Oncologistas 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 toswallow tablets), timing and nature of required assessments. 4. All patients must be able to speak and read in English to ensure consent is informedand documentation of patient-reported outcome measures can be adhered to. 5. Signed, written informed consent.

Exclusion

Exclusion Criteria: 1. Patients who are receiving therapy to reduce gastric acid (including proton pumpInhibitors (e.g. Omeprazole, Pantoprazole, Lansoprazole, Esomeprazole or Histaminetype-2 receptor antagonists e.g. Ranitidine)) at the time of enrolment will beexcluded from the trial. 2. Patients with pre-existing hypomagnesemia as defined by the reference range at theinvestigating sites laboratory. 3. Patients with a history of cardiac arrhythmias including atrial fibrillation orparoxysmal tachycardias. 4. Patients with known metastatic disease. 5. The presence of any serious medical or psychiatric conditions, which might limit theability of the patient to comply with follow up. 6. The presence of any psychological, familial, sociological or geographical conditionpotentially 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 potentialmust have a negative pregnancy test done within 7 days prior to registration.

Study Design

Total Participants: 160
Study Start date:
June 10, 2019
Estimated Completion Date:
October 15, 2021

Study Description

Breast Cancer is the most common cancer type in women in New Zealand and has the second highest mortality (Ministry of Health NZ) Many women with early breast cancer still receive chemotherapy, before or after surgery and delayed nausea is a particular challenge. Ensuring tolerable therapy is critical to improving outcomes, by enabling patients to complete optimal anti-cancer therapy and to improve quality of life during therapy. Despite recent advances in antiemetic regimens, recent trials showed that rates of delayed Chemotherapy-Induced Nausea and Vomiting (CINV) are is in excess of 50%, with significant impacts on quality of life during treatment. This suggests that different mechanisms than those targeted by centrally acting anti-emetics account for such symptoms. There is strong evidence that chemotherapy regimens can result in gastrointestinal mucosal injury and dyspepsia. A number of studies have shown chemotherapy-induced dyspepsia can be relieved by a proton pump inhibitor, but none have reported their use as prophylaxis for delayed CINV, which may be a linked symptom. Proton pump inhibitors are widely used in the treatment of non-malignant dyspeptic conditions and are the most potent medications at reducing gastric acid secretions. They are considered safe in short-term use and are commonly used in clinical practice in cancer patients as well as the wider population. The pharmacokinetics Pantoprazole make it the ideal PPI for this study. The experience of New Zealand Medical Oncologists is that delayed nausea is often completely resolved by the delayed use of a PPI when symptoms occur. In this study we hope to see a 30% difference in the rates of delayed nausea by using a drug which is readily available and of very low cost. This will be the first time it has been used as preventive therapy in this setting. If this benefit occurs, it would significantly improve the treatment journey and may improve compliance to anti-cancer therapies.

Connect with a study center

  • Auckland City Hospital

    Auckland,
    New Zealand

    Site Not Available

  • Christchurch Hospital

    Christchurch,
    New Zealand

    Site Not Available

  • Dunedin Hospital

    Dunedin,
    New Zealand

    Site Not Available

  • Waikato Hospital

    Hamilton,
    New Zealand

    Site Not Available

  • Taranaki Base Hospital

    New Plymouth,
    New Zealand

    Site Not Available

  • Palmerston North Hospital

    Palmerston North,
    New Zealand

    Site Not Available

  • Rotorua Hospital

    Rotorua, 3010
    New Zealand

    Site Not Available

  • Tauranga Hospital

    Tauranga,
    New Zealand

    Site Not Available

  • Wellington Hospital

    Wellington,
    New Zealand

    Site Not Available

  • Whangarei Hospital

    Whangarei, 0148
    New Zealand

    Site Not Available

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