Clinical trial · Interventional
Olanzapine Based Dexamethasone-sparing Regimen for Breast Cancer Patients With Metabolic-risk Factors
Efficacy of an Olanzapine Based Dexamethasone-sparing Regimen in Breast Cancer Patients With Metabolic-risk Factors: A Randomized, Controlled Trial
NCT07743827CI-TRIAL-00120405recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The aim of THE STUDY to determine whether an olanzapine-based dexamethasone-sparing antiemetic regimen is non-inferior to the standard dexamethasone-containing regimen in preventing delayed-phase Chemotherapy-induced nausea and vomiting while reducing metabolic toxicity in breast cancer patients with metabolic risk factors.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Dexamethasone | — | UNRESOLVED | — |
| Olanzapine | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| olanzapine | Drug | — | UNRESOLVED |
| Pantoprazole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Olanzapine-Based Dexamethasone-Sparing Regimen
- description
- * Pantoprazole 40 mg PO daily (1 hour before breakfast) * Olanzapine 5 mg PO daily (at bedtime)
- interventionNames
- Drug: Pantoprazole
- Drug: olanzapine
- type
- ACTIVE_COMPARATOR
- label
- Dexamethasone-Containing Standard Regimen
- description
- * Pantoprazole 40 mg PO daily (1 hour before breakfast) * Olanzapine 5 mg PO daily (at bedtime) * Dexamethasone 4 mg PO BID (total 8 mg/day)
- interventionNames
- Drug: Pantoprazole
- Drug: olanzapine
- Drug: Dexamethasone
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients ≥18 years. * Stage I-III breast cancer. * Scheduled to receive AC chemotherapy. * Presence of metabolic risk factors (diabetes, prediabetes, obesity, metabolic syndrome). * ECOG performance status ≤2. Exclusion Criteria: * Recent systemic corticosteroid use. * Active nausea or vomiting before chemotherapy. * Severe renal or hepatic impairment. * Uncontrolled diabetes or hypertension. * Psychiatric illness affecting adherence. * Pregnancy or lactation. * Active infections or inflammatory diseases. * Participation in another clinical trial
References
Publications (18)
- BACKGROUNDNavari RM, Qin R, Ruddy KJ, Liu H, Powell SF, Bajaj M, Dietrich L, Biggs D, Lafky JM, Loprinzi CL. Olanzapine for the Prevention of Chemotherapy-Induced Nausea and Vomiting. N Engl J Med. 2016 Jul 14;375(2):134-42. doi: 10.1056/NEJMoa1515725. PMID 27410922
- BACKGROUNDHesketh PJ, Kris MG, Basch E, Bohlke K, Barbour SY, Clark-Snow RA, Danso MA, Dennis K, Dupuis LL, Dusetzina SB, Eng C, Feyer PC, Jordan K, Noonan K, Sparacio D, Lyman GH. Antiemetics: ASCO Guideline Update. J Clin Oncol. 2020 Aug 20;38(24):2782-2797. doi: 10.1200/JCO.20.01296. Epub 2020 Jul 13. PMID 32658626
- BACKGROUNDRoila F, Molassiotis A, Herrstedt J, Aapro M, Gralla RJ, Bruera E, Clark-Snow RA, Dupuis LL, Einhorn LH, Feyer P, Hesketh PJ, Jordan K, Olver I, Rapoport BL, Roscoe J, Ruhlmann CH, Walsh D, Warr D, van der Wetering M; participants of the MASCC/ESMO Consensus Conference Copenhagen 2015. 2016 MASCC and ESMO guideline update for the prevention of chemotherapy- and radiotherapy-induced nausea and vomiting and of nausea and vomiting in advanced cancer patients. Ann Oncol. 2016 Sep;27(suppl 5):v119-v133. doi: 10.1093/annonc/mdw270. No abstract available. PMID 27664248
- BACKGROUNDNavari RM. Olanzapine for the prevention and treatment of chronic nausea and chemotherapy-induced nausea and vomiting. Eur J Pharmacol. 2014 Jan 5;722:180-6. doi: 10.1016/j.ejphar.2013.08.048. Epub 2013 Oct 21. PMID 24157985
- BACKGROUNDFardet L, Kassar A, Cabane J, Flahault A. Corticosteroid-induced adverse events in adults: frequency, screening and prevention. Drug Saf. 2007;30(10):861-81. doi: 10.2165/00002018-200730100-00005. PMID 17867724
- BACKGROUNDClore JN, Thurby-Hay L. Glucocorticoid-induced hyperglycemia. Endocr Pract. 2009 Jul-Aug;15(5):469-74. doi: 10.4158/EP08331.RAR. PMID 19454391
- BACKGROUNDvan Raalte DH, Ouwens DM, Diamant M. Novel insights into glucocorticoid-mediated diabetogenic effects: towards expansion of therapeutic options? Eur J Clin Invest. 2009 Feb;39(2):81-93. doi: 10.1111/j.1365-2362.2008.02067.x.