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

Nausea Post Chemotherapy Clinical Trial

— OLNEPA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04669132
• Other study ID #: 38285020.8.0000.0072
• Status: Completed
• Phase: Phase 2
• Start date: December 17, 2020
• Est. completion date: January 17, 2022

Study information

• Verified date: February 2022
• Source: Instituto Brasileiro de Controle do Cancer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The population of the study is women diagnosed with breast cancer, who will start chemotherapy (Doxorubicine and Cyclophosfamide). We will evaluate the control of nausea and vomiting in the first cycle of chemotherapy, utilizing Netupitant (300mg) + palonosetron (0,56mg) in day 1 and Olanzapine 5mg starting on Day 0, given once a day for five days. The primary endpoint of this study is complete response rate (no nausea, no emesis no use of rescue medication).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 17, 2022
• Est. primary completion date: December 17, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Breast cancer hitologically confirmed

• 18 Years and older (Adult, Older Adult)

• Patients about to start use of Doxorubicine 60mg/m2 + Cyclophosfamide 600mg/m2

• No previous chemotherapy for breast cancer

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Nausea
• Nausea Post Chemotherapy
• Vomiting

Intervention

Drug:
• Olanzapine
- Olanzapine 5mg, administered once daily, during 5 days (day before chemotherapy, the D day of the chemotherapy and 3 day after chemotherapy)
• Netupitant
- Netupitanto 300 mg, once daily, on chemotherapy day;
• Palonesetron
- Palonosetron 0.56 mg, once daily, on chemotherapy day;

Locations

Country	Name	City	State
Brazil	IBCC Oncologia	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Brasileiro de Controle do Cancer

Country where clinical trial is conducted

Brazil, 

References & Publications (10)

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. — View Citation

Cruz FM, de Iracema Gomes Cubero D, Taranto P, Lerner T, Lera AT, da Costa Miranda M, da Cunha Vieira M, de Souza Fêde 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. — View Citation

de Castro Baccarin AL, Irene MN, de Iracema Gomes Cubero D, Luz AS, Castro SN, Sordi R, Móz 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Obradovic MMS, Hamelin B, Manevski N, Couto JP, Sethi A, Coissieux MM, Münst 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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nausea Complete Response Rate	Defined as no nausea and no rescue medication	5 days after chemotherapeutic administration
Secondary	Complete Emesis Control	Defined as no emetic episodes and no use of rescue medications	For the following time periods: 0-24 hours (acute), 24+ to 120 hours (delayed), and 0-120 hours (overall)
Secondary	Complete Control	Defined as no nausea, no emesis and no rescue medication	For the following time periods: 0-24 hours (acute), 24+ to 120 hours (delayed), and 0-120 hours (overall)