Efficacy of Olanzapine, Netupitant and Palonosetron in Controlling Nausea and Vomiting Associated With Highly Emetogenic Chemotherapy in Patients With Breast Cancer

NCT04669132 | Completed Phase 2 DMC

• 1 other identifier: 38285020.8.0000.0072
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is a longitudinal, one arm, prospective phase II study, designed to evaluate the efficacy of Olanzapine Netupitant and Palonosetron in the controll of nausea and vomiting induced by highly emetogenic chemotherapy.

Conditions

Nausea Post Chemotherapy

Keywords

olanzapine; emetogenic; chemotherapy; breast cancer; nausea

Outcome Measures

Primary Outcomes (1)

• Nausea Complete Response Rate

  Defined as no nausea and no rescue medication

  5 days after chemotherapeutic administration

Secondary Outcomes (2)

• Complete Emesis Control

  For the following time periods: 0-24 hours (acute), 24+ to 120 hours (delayed), and 0-120 hours (overall)

• Complete Control

  For the following time periods: 0-24 hours (acute), 24+ to 120 hours (delayed), and 0-120 hours (overall)

Study Arms (1)

Olanzapine + Netupitanto + Palonosetron

EXPERIMENTAL

Olanzapine 5 mg/day d 0-4 + Netupitanto 300 mg/day d 1 + Palonosetron 0.56 mg/day d 1;

Drug: Olanzapine; Drug: Netupitant; Drug: Palonesetron

Interventions

Olanzapine DRUG

\- Olanzapine 5mg, administered once daily, during 5 days (day before chemotherapy, the D day of the chemotherapy and 3 day after chemotherapy)

Olanzapine + Netupitanto + Palonosetron

Netupitant DRUG

\- Netupitanto 300 mg, once daily, on chemotherapy day;

Olanzapine + Netupitanto + Palonosetron

Palonesetron DRUG

\- Palonosetron 0.56 mg, once daily, on chemotherapy day;

Olanzapine + Netupitanto + Palonosetron

Eligibility Criteria

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

You may qualify if:

• Breast cancer hitologically confirmed
• Years and older (Adult, Older Adult)
• Patients about to start use of Doxorubicine 60mg/m2 + Cyclophosfamide 600mg/m2
• No previous chemotherapy for breast cancer

You may not qualify if:

• Patients not capable of completing the questionnaire
• Patients with other condition that could cause nausea and emesis
• Use of opioids
• Use of antipsychotic medications
• Patients not capable of taking medications orally

Sponsors & Collaborators

• Instituto Brasileiro de Controle do Cancer: lead

Study Sites (1)

IBCC Oncologia

São Paulo, 03102002, Brazil

Location

Related Publications (11)

• Razvi Y, Chan S, McFarlane T, McKenzie E, Zaki P, DeAngelis C, Pidduck W, Bushehri A, Chow E, Jerzak KJ. ASCO, NCCN, MASCC/ESMO: a comparison of antiemetic guidelines for the treatment of chemotherapy-induced nausea and vomiting in adult patients. Support Care Cancer. 2019 Jan;27(1):87-95. doi: 10.1007/s00520-018-4464-y. Epub 2018 Oct 3.

  PMID: 30284039 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

• Gralla R, Lichinitser M, Van Der Vegt S, Sleeboom H, Mezger J, Peschel C, Tonini G, Labianca R, Macciocchi A, Aapro M. Palonosetron improves prevention of chemotherapy-induced nausea and vomiting following moderately emetogenic chemotherapy: results of a double-blind randomized phase III trial comparing single doses of palonosetron with ondansetron. Ann Oncol. 2003 Oct;14(10):1570-7. doi: 10.1093/annonc/mdg417.

  PMID: 14504060 BACKGROUND

• Wang H, Wang Y, Rayburn ER, Hill DL, Rinehart JJ, Zhang R. Dexamethasone as a chemosensitizer for breast cancer chemotherapy: potentiation of the antitumor activity of adriamycin, modulation of cytokine expression, and pharmacokinetics. Int J Oncol. 2007 Apr;30(4):947-53.

  PMID: 17332934 BACKGROUND

• Kim MH, Kim DW, Park S, Kim JH, Lee KY, Hwang J, Yoo YC. Single dose of dexamethasone is not associated with postoperative recurrence and mortality in breast cancer patients: a propensity-matched cohort study. BMC Cancer. 2019 Mar 20;19(1):251. doi: 10.1186/s12885-019-5451-5.

  PMID: 30894164 BACKGROUND

• Chen YX, Wang Y, Fu CC, Diao F, Song LN, Li ZB, Yang R, Lu J. Dexamethasone enhances cell resistance to chemotherapy by increasing adhesion to extracellular matrix in human ovarian cancer cells. Endocr Relat Cancer. 2010 Jan 29;17(1):39-50. doi: 10.1677/ERC-08-0296. Print 2010 Mar.

  PMID: 19776289 BACKGROUND

• Obradovic MMS, Hamelin B, Manevski N, Couto JP, Sethi A, Coissieux MM, Munst S, Okamoto R, Kohler H, Schmidt A, Bentires-Alj M. Glucocorticoids promote breast cancer metastasis. Nature. 2019 Mar;567(7749):540-544. doi: 10.1038/s41586-019-1019-4. Epub 2019 Mar 13.

  PMID: 30867597 BACKGROUND

• de Castro Baccarin AL, Irene MN, de Iracema Gomes Cubero D, Luz AS, Castro SN, Sordi R, Moz LES, Del Giglio A. The feasibility of dexamethasone omission in weekly paclitaxel treatment for breast cancer patients. Support Care Cancer. 2019 Mar;27(3):927-931. doi: 10.1007/s00520-018-4381-0. Epub 2018 Aug 1.

  PMID: 30069696 BACKGROUND

• Navari RM, Nagy CK, Gray SE. The use of olanzapine versus metoclopramide for the treatment of breakthrough chemotherapy-induced nausea and vomiting in patients receiving highly emetogenic chemotherapy. Support Care Cancer. 2013 Jun;21(6):1655-63. doi: 10.1007/s00520-012-1710-6. Epub 2013 Jan 12.

  PMID: 23314603 BACKGROUND

• Cruz FM, de Iracema Gomes Cubero D, Taranto P, Lerner T, Lera AT, da Costa Miranda M, da Cunha Vieira M, de Souza Fede AB, Schindler F, Carrasco MM, de Afonseca SO, Pinczowski H, del Giglio A. Gabapentin for the prevention of chemotherapy- induced nausea and vomiting: a pilot study. Support Care Cancer. 2012 Mar;20(3):601-6. doi: 10.1007/s00520-011-1138-4. Epub 2011 Apr 5.

  PMID: 21465325 BACKGROUND

• Reboucas CV, Alves RB, Yamada AMTD, Del Giglio A, Cruz FJSM. Omission of dexamethasone in prophylaxis for highly emetogenic chemotherapy in patients with breast cancer. Einstein (Sao Paulo). 2025 May 12;23:eAO1124. doi: 10.31744/einstein_journal/2025AO1124. eCollection 2025.

  PMID: 40367007 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Nausea

Interventions

Olanzapine; netupitant

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Camilla Rebouças, MD

  Instituto Brasileiro de Controle do Cancer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 16, 2020
• Study Start: December 17, 2020
• Primary Completion: December 17, 2021
• Study Completion: January 17, 2022
• Last Updated: February 23, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)