OncologyPhase 2PantoCINNCT03948477
Pantoprazole Prophylaxis Against Delayed CINV for Patients Receiving Breast Cancer Chemotherapy
A Phase 2 study testing Pantoprazole 40mg in people with Oncology and Breast Cancer, run by University of Auckland, New Zealand at 10 sites in New Zealand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncology, Breast Cancer, Chemotherapy-induced Nausea and Vomiting
- What is being tested?
- Pantoprazole 40mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 10 sitesNew Zealand
- Study dates
- 10 Jun 2019to 15 Oct 2021
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- -
Who cannot join
- 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.
- -
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
New Zealand10 sites
Auckland City Hospital
Auckland
Christchurch Hospital
Christchurch
Dunedin Hospital
Dunedin
Waikato Hospital
Hamilton
Taranaki Base Hospital
New Plymouth
Palmerston North Hospital
Palmerston North
Rotorua Hospital
Rotorua, 3010
Tauranga Hospital
Tauranga
Wellington Hospital
Wellington
Whangarei Hospital
Whangarei, 0148
About this study
Official title: Phase II, Randomised, Double-blinded, Placebo Controlled, Crossover Trial to Assess Pantoprazole's Effectiveness as Prophylaxis Against Delayed CINV in Patients Receiving Adjuvant or Neoadjuvant Breast Cancer Chemotherapy
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.
Read more
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.
Read the detailed 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.
- Being tested
- Pantoprazole 40mg, Placebo
- Medical subject headings
- Neoplasms, Breast Neoplasms, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pantoprazole 40mgDrug
Also called Apo-Pantoprazole
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.
PlaceboDrug
Matched placebo
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Pantoprazole 40mg; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured on day 5, after chemotherapy
Secondary outcomes (7)
Nausea MAT scores
Whether Pantoprazole improves nausea MAT scores over days 2-5
Measured: Days 2-5 following chemotherapy for cycle 1 and 2 (each cycle is either 14 or 21 days)
Vomiting MAT scores
Whether Pantoprazole reduces the number of episodes of vomiting (MAT) over days 2-5
Measured: Days 2-5 following chemotherapy for cycle 1 and 2 (each cycle is either 14 or 21 days)
Heartburn improvement
Whether Pantoprazole improves heartburn score (measured using the FSSG for reflux and/or dyspepsia) as self-reported on day 5 regarding days 2-5.
Measured: Days 2-5 following chemotherapy for cycle 1 and 2 (each cycle is either 14 or 21 days)
Heartburn and Nausea scores
Whether FSSG scores (heartburn) are associated with the MAT nausea scores reported by the patient over days 2-5.
Measured: 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
Whether Pantoprazole lowers the requirement for breakthrough medications (as self-recorded by the patients on days 2-5).
Measured: Days 2-5 following chemotherapy for cycle 1 and 2 (each cycle is either 14 or 21 days)
Patient preference
Whether Pantoprazole is preferred by patients over Placebo (by using a patient preference survey at the end of cycle 2).
Measured: end of chemotherapy cycle 2 (cycle 2 is either 14 or 21 days)
Adverse events
To assess whether adverse events (including hypomagnesemia, diarrhoea, abdominal pain and headache as defined by CT CAE version 4.03) are more common on Pantoprazole than on Placebo.
Measured: From date of consent to 28 days after the last study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start10 Jun 2019
- Primary completion15 Oct 2021
- Study completion15 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OncologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double-blinded, randomised, crossover trial, phase II, stratified by the chemotherapy regimen
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Auckland, New Zealand
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Richard Isaacs, University of Auckland, New Zealand
- Investigators
- Ricard Isaacs, MBChB FRACP, Principal investigator, Midcentral Regional Cancer Centre ServicesNavin Wewala, MBChB FRACP, Principal investigator, Midcentral Regional Cancer Centre Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03948477
- Sponsor's protocol ID
- CTNZ-2017-01
- Acronym
- PantoCIN
- Status last verified
- May 2022
- First submitted
- 28 Mar 2019
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40394328
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Randomised, Double-blinded, Placebo Controlled, Crossover Trial to Assess Pantoprazole's Effectiveness as Prophylaxis Against Delayed CINV in Patients Receiving Adjuvant or Neoadjuvant Breast Cancer Chemotherapy
- ClinicalTrials.gov ID
- NCT03948477
- Acronym / sponsor ID
- PantoCIN / CTNZ-2017-01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of Auckland, New ZealandUniversity, hospital or other
- Study start
- 10 Jun 2019 (actual)
- Primary completion
- 15 Oct 2021 (actual)
- Study completion
- 15 Oct 2021 (actual)
- First posted
- 14 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Double-blinded, randomised, crossover trial, phase II, stratified by the chemotherapy regimen
| Arm | Type | Receives |
|---|---|---|
| Pantoprazole/Placebo | Other | Drug: Pantoprazole 40mg, Drug: PlaceboParticipants 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 |
| Placebo/Pantoprazole | Other | Drug: Pantoprazole 40mg, Drug: PlaceboParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pantoprazole 40mgAlso: Apo-PantoprazoleProton 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. | Drug | Pantoprazole/Placebo, Placebo/Pantoprazole |
| PlaceboMatched placebo | Drug | Pantoprazole/Placebo, Placebo/Pantoprazole |
Primary outcome
Reduce the incidence of delayed CINV in patients receiving adjuvant or neoadjuvant breast cancer chemotherapy
Time frame: Measured on day 5, after 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.
7 secondary outcomes
Nausea MAT scores
Time frame: Days 2-5 following chemotherapy for cycle 1 and 2 (each cycle is either 14 or 21 days)
Vomiting MAT scores
Time frame: Days 2-5 following chemotherapy for cycle 1 and 2 (each cycle is either 14 or 21 days)
Heartburn improvement
Time frame: Days 2-5 following chemotherapy for cycle 1 and 2 (each cycle is either 14 or 21 days)
Heartburn and Nausea scores
Time frame: 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
Time frame: Days 2-5 following chemotherapy for cycle 1 and 2 (each cycle is either 14 or 21 days)
Patient preference
Time frame: end of chemotherapy cycle 2 (cycle 2 is either 14 or 21 days)
Adverse events
Time frame: From date of consent to 28 days after the last study treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Derived from this study: PubMed 40394328Wewala 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.
- Cancer Trials New Zealand website study recordLink provided by the sponsor.
- Breast Cancer Foundation website study record (Co-funder)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricard Isaacs, MBChB FRACP principal investigator
Midcentral Regional Cancer Centre Services
Navin Wewala, MBChB FRACP principal investigator
Midcentral Regional Cancer Centre Services
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pantoprazole 40mg in people with Oncology and Breast Cancer, run by University of Auckland, New Zealand at 10 sites in New Zealand.
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 6 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 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in New Zealand. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Reduce the incidence of delayed CINV in patients receiving adjuvant or neoadjuvant breast cancer chemotherapy (time frame: Measured on day 5, after chemotherapy). 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 NCT03948477, which also lists 1 linked publication.
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 25 May 2022.