|Full title:||A phase II, randomised, double-blinded, placebo controlled, crossover trial to assess Pantoprazole’s effectiveness as prophylaxis against delayed chemotherapy-induced nausea and vomiting (CINV) in patients receiving adjuvant or neoadjuvant breast cancer chemotherapy|
|Status:||Open to recruitment|
Many patients with early breast cancer continue to suffer from nausea and vomiting induced by adjuvant chemotherapy. There is a sound scientific rationale and an anecdotal evidence base that proton pump inhibitors will ameliorate these symptoms and potentially enable more effective and tolerable delivery of curative chemotherapy.
There is very little doubt that chemotherapy can cause gastric mucosal damage, but the links between this damage and nausea or wellbeing is less clear, highlighting the need for further research.
The aim of the PantoCIN Study is to determine the anti-emetic activity of Pantoprazole in the prophylaxis of delayed chemotherapy induced nausea and vomiting in patients undergoing adjuvant or neo-adjuvant breast cancer treatment. If this trial shows improved control of nausea in patients receiving chemotherapy for breast cancer, the results may also be applicable to other moderately emetogenic and highly emetogenic chemotherapy regimens in oncology. The results of this trial have the potential to inform further clinical trials in breast and other cancers, as well as improve our understanding of the mechanisms behind delayed CINV.
OPEN: Palmerston North, Tauranga, Rotorua, Hamilton, Wellington, Auckland, Christchurch, Dunedin, New Plymouth, Whangarei
ALMOST OPEN: Hawkes Bay
|Lead Investigator:||Dr Richard Isaacs, Dr Navin Wewala (MidCentral District Health Board)|
|Contact:||Sarah Benge (firstname.lastname@example.org, tel: 09 923 3585)|
|Sponsor:||University of Auckland|
|Funder:||Breast Cancer Foundation New Zealand, Breast Cancer Trials (Australia)|
|Trial Registry reference:||NCT03948477 (click for more details)|
These documents are the current versions and are password protected – please contact, Louise Clement (PantoCIN Trial Manager) for access email@example.com
PantoCIN Protocol V5 18-Jun-2020
Participant Information Sheet/Consent Form v3 26-Apr-2019
Patient Reported Outcomes (PRO) Guidance for PARTICIPANTS v1 10-May-2019
Patient Reported Outcomes (PRO) Guidance for STAFF v2 06-Jun-2019
PantoCIN Paper CRFs v2 08-Sep-2019