Olanzapine Based Dexamethasone-sparing Regimen for Breast Cancer Patients With Metabolic-risk Factors

NCT07743827 | Recruiting

• 1 other identifier: 00012098 -FWA NO: 00018699
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Olanzapine; Dexamethasone; Breast Cancer

Keywords

dexamethasone-sparing regimen; olanzapine; metabolic-risk factors; breast cancer patients

Outcome Measures

Primary Outcomes (2)

• Complete response during the delayed phase chemotherapy-Induced Nausea and Vomiting (CINV)

  Proportion of patients with no emetic episodes and no use of rescue antiemetic medication during the delayed phase, comparing the olanzapine-based dexamethasone-sparing regimen (Arm A) to the standard dexamethasone-containing regimen (Arm B).

  24-120 hours after initiation of AC chemotherapy (Day 0)

• Total Control during the delayed phase

  Proportion of patients with no emetic episodes, no use of rescue antiemetic medication, and no nausea during the delayed phase, comparing the two treatment arms.

  24-120 hours after initiation of AC chemotherapy (Day 0)

Secondary Outcomes (12)

• Change in Fasting Plasma Glucose

  Baseline (Day 0), Day 4, and Day 21

• Change in Insulin Resistance (HOMA-IR)

  Baseline (Day 0), Day 4, and Day 21

• Purine Turnover / Metabolic Marker (Uric Acid) Assessment

  Baseline (Day 0), Day 4, and Day 21

• Incidence of Hyperglycemia

  From Baseline (Day 0) through Recovery Phase (Day 21)

• Intermediate Glycemic Control (Serum Fructosamine)

  Baseline (Day 0) to Day 21

Other Outcomes (1)

• Odds Ratios for Baseline Predictors of Metabolic Toxicity (Exploratory Logistic Regression)

  Baseline (Day 0) through Recovery Phase (Day 21)

Study Arms (2)

Olanzapine-Based Dexamethasone-Sparing Regimen

EXPERIMENTAL

* Pantoprazole 40 mg PO daily (1 hour before breakfast) * Olanzapine 5 mg PO daily (at bedtime)

Drug: Pantoprazole; Drug: olanzapine

Dexamethasone-Containing Standard Regimen

ACTIVE COMPARATOR

* 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)

Drug: Pantoprazole; Drug: olanzapine; Drug: Dexamethasone

Interventions

Pantoprazole DRUG

Administered as 40 mg orally once daily on Days 1 to 3 (1 hour before breakfast) in both arms as standard gastroprotective co-medication to prevent chemotherapy- and corticosteroid-induced gastritis and dyspepsia.

Dexamethasone-Containing Standard Regimen; Olanzapine-Based Dexamethasone-Sparing Regimen

olanzapine DRUG

Administered as 5 mg orally once daily at bedtime, Days 1-3, for delayed-phase antiemetic prophylaxis.

Dexamethasone-Containing Standard Regimen; Olanzapine-Based Dexamethasone-Sparing Regimen

Dexamethasone DRUG

Administered as 4 mg orally twice daily (total 8 mg/day), Days 1-3, for delayed-phase antiemetic prophylaxis.

Dexamethasone-Containing Standard Regimen

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria Main University Hospital

Alexandria, Alexandria Governorate, 21526, Egypt

RECRUITING

Related Publications (18)

• Navari 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 BACKGROUND

• Hesketh 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 BACKGROUND

• Roila 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 BACKGROUND

• Navari 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 BACKGROUND

• Fardet 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 BACKGROUND

• Clore JN, Thurby-Hay L. Glucocorticoid-induced hyperglycemia. Endocr Pract. 2009 Jul-Aug;15(5):469-74. doi: 10.4158/EP08331.RAR.

  PMID: 19454391 BACKGROUND

• van 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.

  PMID: 19200161 BACKGROUND

• Ligibel JA, Alfano CM, Courneya KS, Demark-Wahnefried W, Burger RA, Chlebowski RT, Fabian CJ, Gucalp A, Hershman DL, Hudson MM, Jones LW, Kakarala M, Ness KK, Merrill JK, Wollins DS, Hudis CA. American Society of Clinical Oncology position statement on obesity and cancer. J Clin Oncol. 2014 Nov 1;32(31):3568-74. doi: 10.1200/JCO.2014.58.4680. Epub 2014 Oct 1.

  PMID: 25273035 BACKGROUND

• Mizukami N, Yamauchi M, Koike K, Watanabe A, Ichihara K, Masumori N, Yamakage M. Olanzapine for the prevention of chemotherapy-induced nausea and vomiting in patients receiving highly or moderately emetogenic chemotherapy: a randomized, double-blind, placebo-controlled study. J Pain Symptom Manage. 2014 Mar;47(3):542-50. doi: 10.1016/j.jpainsymman.2013.05.003. Epub 2013 Jul 12.

  PMID: 23856100 BACKGROUND

• Uchino R, Shibutani Y. Dose-dependent Efficacy of Olanzapine for Chemotherapy-induced Nausea and Vomiting: A Systematic Review and Meta-analysis. Anticancer Res. 2025 Sep;45(9):3605-3616. doi: 10.21873/anticanres.17725.

  PMID: 40876984 BACKGROUND

• Celio L, Cortinovis D, Cogoni AA, Cavanna L, Martelli O, Carnio S, Collova E, Bertolini F, Petrelli F, Cassano A, Chiari R, Zanelli F, Pisconti S, Vittimberga I, Letizia A, Misino A, Gernone A, Bonizzoni E, Pilotto S, De Placido S, Bria E. Dexamethasone-Sparing Regimens with Oral Netupitant and Palonosetron for the Prevention of Emesis Caused by High-Dose Cisplatin: A Randomized Noninferiority Study. Oncologist. 2021 Oct;26(10):e1854-e1861. doi: 10.1002/onco.13851. Epub 2021 Jun 18.

  PMID: 34101934 BACKGROUND

• Umpierrez GE, Pasquel FJ. Management of Inpatient Hyperglycemia and Diabetes in Older Adults. Diabetes Care. 2017 Apr;40(4):509-517. doi: 10.2337/dc16-0989.

  PMID: 28325798 BACKGROUND

• Jordan K, Jahn F, Aapro M. Recent developments in the prevention of chemotherapy-induced nausea and vomiting (CINV): a comprehensive review. Ann Oncol. 2015 Jun;26(6):1081-1090. doi: 10.1093/annonc/mdv138. Epub 2015 Mar 9.

  PMID: 25755107 BACKGROUND

• Bloechl-Daum B, Deuson RR, Mavros P, Hansen M, Herrstedt J. Delayed nausea and vomiting continue to reduce patients' quality of life after highly and moderately emetogenic chemotherapy despite antiemetic treatment. J Clin Oncol. 2006 Sep 20;24(27):4472-8. doi: 10.1200/JCO.2006.05.6382.

  PMID: 16983116 BACKGROUND

• Bhargave S, Sharma V, Kataria B, Batra A, Pushpam D, Sharma A, Pramanik R, Malik PS, Sahoo RK, Khurana S, Singh V, Bakhshi S, Sharma A, Kumar L, Kumar A. Olanzapine Versus NK1 Receptor Antagonist for Prevention of Carboplatin-Induced (AUC >/=4) Emesis: A Phase III, Double-Blind, Placebo-Controlled Randomized Trial From India. JCO Glob Oncol. 2025 Mar;11:e2400166. doi: 10.1200/GO.24.00166. Epub 2025 Mar 24.

  PMID: 40127383 BACKGROUND

• Radhakrishnan V, Venkatakrishnan K, Perumal Kalaiyarasi J, Selvarajan G, Mahaboobasha N, Victor PV, Anbazhagan M, Sivanandam DM, Rajaraman S. Dexamethasone-Free Antiemetic Prophylaxis for Highly Emetogenic Chemotherapy: A Double-Blind, Phase III Randomized Controlled Trial (CINV POD study). JCO Glob Oncol. 2024 Jan;10:e2300301. doi: 10.1200/GO.23.00301.

  PMID: 38237092 BACKGROUND

• Badarudin NS, Mohamed Shah N, Mohd Tahir NA, Ahmat ANMF, Ismail F, Islahudin F, Yusak S, Muhammad S, Mohd Kassim KNB. Health-Related Quality of Life and Economic Analysis of Olanzapine Versus Aprepitant in Preventing Chemotherapy-Induced Nausea and Vomiting in Patients Receiving Highly Emetogenic Chemotherapy in Malaysia. Value Health Reg Issues. 2024 Nov;44:101028. doi: 10.1016/j.vhri.2024.101028. Epub 2024 Jul 27.

  PMID: 39068865 BACKGROUND

• Liu G, Jin Y, Jiang Y, Zhao J, Jiang C, Zhang Z, Zhao L, Li H, Chen F, Wang J, Fan H, Li Z, Jia Y, Jin G, Li Q. A Comparison of the Efficacy of 5 mg Olanzapine and Aprepitant in the Prevention of Multiple-Day Cisplatin Chemotherapy-Induced Nausea and Vomiting. Int J Clin Pract. 2022 Sep 7;2022:5954379. doi: 10.1155/2022/5954379. eCollection 2022.

  PMID: 36128262 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Pantoprazole; Olanzapine; Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Benzodiazepines; Benzazepines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

mohamed younes, B.pharmacy

CONTACT

+201500993053; mohamedyounes93ly@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: August 4, 2026
• Study Start: May 10, 2026
• Primary Completion (Estimated): September 29, 2027
• Study Completion (Estimated): October 15, 2027
• Last Updated: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)