Pantoprazole Prophylaxis Against Delayed CINV for Patients Receiving Breast Cancer Chemotherapy
Keywords
Abstract
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.
Dates
Last Verified: | 04/30/2019 |
First Submitted: | 03/27/2019 |
Estimated Enrollment Submitted: | 05/08/2019 |
First Posted: | 05/13/2019 |
Last Update Submitted: | 05/08/2019 |
Last Update Posted: | 05/13/2019 |
Actual Study Start Date: | 05/13/2019 |
Estimated Primary Completion Date: | 06/13/2021 |
Estimated Study Completion Date: | 07/14/2021 |
Condition or disease
Intervention/treatment
Drug: Pantoprazole 40mg
Drug: Placebo
Phase
Arm Groups
Arm | Intervention/treatment |
---|---|
Other: Pantoprazole/Placebo 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 | |
Other: Placebo/Pantoprazole 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 |
Eligibility Criteria
Ages Eligible for Study | 18 Years To 18 Years |
Sexes Eligible for Study | All |
Accepts Healthy Volunteers | Yes |
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. - 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. - |
Outcome
Primary Outcome Measures
1. Reduce the incidence of delayed CINV in patients receiving adjuvant or neoadjuvant breast cancer chemotherapy [Measured on day 5, after chemotherapy]
Secondary Outcome Measures
1. Nausea MAT scores [Days 2-5 following chemotherapy for cycle 1 and 2 (each cycle is either 14 or 21 days)]
2. Vomiting MAT scores [Days 2-5 following chemotherapy for cycle 1 and 2 (each cycle is either 14 or 21 days)]
3. Heartburn improvement [Days 2-5 following chemotherapy for cycle 1 and 2 (each cycle is either 14 or 21 days)]
4. 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.]
5. Use of breakthrough medications [Days 2-5 following chemotherapy for cycle 1 and 2 (each cycle is either 14 or 21 days)]
6. Patient preference [end of chemotherapy cycle 2 (cycle 2 is either 14 or 21 days)]
7. Adverse events [From date of consent to 28 days after the last study treatment]
Other Outcome Measures
1. Effect of chemotherapy regimen impacts use of Pantoprazole in terms of delayed CINV [Measured on day 5, after chemotherapy]
2. Cycle effect [Cycle 1 to end of cycle 2 (each cycle is either 14 or 21 days)]