Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03948477




Registration number
NCT03948477
Ethics application status
Date submitted
28/03/2019
Date registered
14/05/2019
Date last updated
25/05/2022

Titles & IDs
Public title
Pantoprazole Prophylaxis Against Delayed CINV for Patients Receiving Breast Cancer Chemotherapy
Scientific 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
Secondary ID [1] 0 0
CTNZ-2017-01
Universal Trial Number (UTN)
Trial acronym
PantoCIN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oncology 0 0
Breast Cancer 0 0
Chemotherapy-induced Nausea and Vomiting 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Pantoprazole 40mg
Treatment: Drugs - Placebo

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


Treatment: Drugs: Pantoprazole 40mg
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.

Treatment: Drugs: Placebo
Matched placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Reduce the incidence of delayed CINV in patients receiving adjuvant or neoadjuvant breast cancer chemotherapy
Timepoint [1] 0 0
Measured on day 5, after chemotherapy
Secondary outcome [1] 0 0
Nausea MAT scores
Timepoint [1] 0 0
Days 2-5 following chemotherapy for cycle 1 and 2 (each cycle is either 14 or 21 days)
Secondary outcome [2] 0 0
Vomiting MAT scores
Timepoint [2] 0 0
Days 2-5 following chemotherapy for cycle 1 and 2 (each cycle is either 14 or 21 days)
Secondary outcome [3] 0 0
Heartburn improvement
Timepoint [3] 0 0
Days 2-5 following chemotherapy for cycle 1 and 2 (each cycle is either 14 or 21 days)
Secondary outcome [4] 0 0
Heartburn and Nausea scores
Timepoint [4] 0 0
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.
Secondary outcome [5] 0 0
Use of breakthrough medications
Timepoint [5] 0 0
Days 2-5 following chemotherapy for cycle 1 and 2 (each cycle is either 14 or 21 days)
Secondary outcome [6] 0 0
Patient preference
Timepoint [6] 0 0
end of chemotherapy cycle 2 (cycle 2 is either 14 or 21 days)
Secondary outcome [7] 0 0
Adverse events
Timepoint [7] 0 0
From date of consent to 28 days after the last study treatment

Eligibility
Key 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.

-
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

-

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/06/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/10/2021
Sample size
Target
Accrual to date
Final
160
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch
Country [3] 0 0
New Zealand
State/province [3] 0 0
Dunedin
Country [4] 0 0
New Zealand
State/province [4] 0 0
Hamilton
Country [5] 0 0
New Zealand
State/province [5] 0 0
New Plymouth
Country [6] 0 0
New Zealand
State/province [6] 0 0
Palmerston North
Country [7] 0 0
New Zealand
State/province [7] 0 0
Rotorua
Country [8] 0 0
New Zealand
State/province [8] 0 0
Tauranga
Country [9] 0 0
New Zealand
State/province [9] 0 0
Wellington
Country [10] 0 0
New Zealand
State/province [10] 0 0
Whangarei

Funding & Sponsors
Primary sponsor type
Other
Name
University of Auckland, New Zealand
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03948477
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ricard Isaacs, MBChB FRACP
Address 0 0
Midcentral Regional Cancer Centre Services
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries