Clinical trial · Interventional
Comparing the Current Hydration Regimen for the ABC02 Chemotherapy Regimen Versus a Shorter Hydration
A Prospective Study of Tolerance Comparing the Current Hydration Regimen for the ABC02 Chemotherapy Regimen Versus a Shorter Hydration
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an open label study for any patients with a bile duct cancer or gallbladder cancer, who will be treated with gemcitabine and cisplatin chemotherapy (the ABC02 regime). Patients recruited onto this study will have a reduction of their hydration time and be given Akynzeo as an anti-sickness drug, to assess tolerability compared to the current standard of care. The aim of this research is to assess the tolerability of a shorter hydration time, which may improve patient satisfaction as they would then spend less time in hospital having chemotherapy, saving both time and money for the institutions also.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gallbladder Cancer | Malignant Gallbladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Shortened hydration time and dispensary of Akynzeo | Combination Product | — | UNRESOLVED |
| Standard of care | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Shortened hydration time with dispensary of Akynzeo
- description
- ABC-02 regime - gemcitabine and cisplatin with a shortened hydration time and administration of a newer antiemetic
- interventionNames
- Combination Product: Shortened hydration time and dispensary of Akynzeo
- type
- ACTIVE_COMPARATOR
- label
- Standard of care
- description
- ABC-02 regime - gemcitabine and cisplatin with currently approved hydration time and administration of the current choice of antiemetic
- interventionNames
- Combination Product: Standard of care
Primary outcomes (1)
- measure
- Nausea according to the Common Terminology Criteria for Adverse Events (CTCAE) V4.03
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adults with normal renal function at the start i.e. eGFR\>60, Performance status 0 and 1, controlled nausea and vomiting at baseline. * ECOG performance status 0 or 1 * Diagnosed with either cholangio carcinoma, gallbladder cancer, pulmonary cancer or pancreatic cancer. Patients should be able to tolerate 1 litre of oral fluid pre-treatment and post treatment. * Decision to treat with the gemcitabine and cisplatin used in the ABC02 trial. Exclusion Criteria: * Participants under the age of 18 years old with Chronic renal impairment. The standard exclusion of renal impairment for cisplatin implies that this study would not be offered to patients, who can't be safely offered cisplatin * Uncontrolled nausea or vomiting * Unable to drink 1 litre of fluid
References
Publications (0)
Data not yet available