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Trial details imported from ClinicalTrials.gov

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

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

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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

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)

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT03948477