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

Primary Purpose

Nausea Post Chemotherapy

Status

Completed

Phase

Phase 2

Locations

Brazil

Study Type

Interventional

Intervention

Olanzapine

Netupitant

Palonesetron

About this trial

This is an interventional prevention trial for Nausea Post Chemotherapy focused on measuring olanzapine, emetogenic, chemotherapy, breast cancer, nausea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

IBCC Oncologia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Olanzapine + Netupitanto + Palonosetron

Arm Description

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

Outcomes

Primary Outcome Measures

Nausea Complete Response Rate

Defined as no nausea and no rescue medication

Secondary Outcome Measures

Complete Emesis Control

Defined as no emetic episodes and no use of rescue medications

Complete Control

Defined as no nausea, no emesis and no rescue medication

Full Information

NCT ID

NCT04669132

First Posted

December 8, 2020

Last Updated

February 7, 2022

Sponsor

Instituto Brasileiro de Controle do Cancer

1. Study Identification

Unique Protocol Identification Number

NCT04669132

Brief Title

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

Acronym

OLNEPA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

December 17, 2020 (Actual)

Primary Completion Date

December 17, 2021 (Actual)

Study Completion Date

January 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Instituto Brasileiro de Controle do Cancer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nausea Post Chemotherapy

Keywords

olanzapine, emetogenic, chemotherapy, breast cancer, nausea

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Olanzapine + Netupitanto + Palonosetron

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Olanzapine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Netupitant

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Palonesetron

Intervention Description

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

Primary Outcome Measure Information:

Title

Nausea Complete Response Rate

Description

Defined as no nausea and no rescue medication

Time Frame

5 days after chemotherapeutic administration

Secondary Outcome Measure Information:

Title

Complete Emesis Control

Description

Defined as no emetic episodes and no use of rescue medications

Time Frame

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

Title

Complete Control

Description

Defined as no nausea, no emesis and no rescue medication

Time Frame

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Camilla Rebouças, MD

Organizational Affiliation

Instituto Brasileiro de Controle do Cancer

Official's Role

Principal Investigator

Facility Information:

Facility Name

IBCC Oncologia

City

São Paulo

ZIP/Postal Code

03102002

Country

Brazil

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30284039

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.

Results Reference

background

PubMed Identifier

27664248

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. doi: 10.1093/annonc/mdw270. No abstract available.

Results Reference

background

PubMed Identifier

14504060

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. doi: 10.1093/annonc/mdg417.

Results Reference

background

PubMed Identifier

17332934

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.

Results Reference

background

PubMed Identifier

30894164

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.

Results Reference

background

PubMed Identifier

19776289

Citation

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.

Results Reference

background

PubMed Identifier

30867597

Citation

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.

Results Reference

background

PubMed Identifier

30069696

Citation

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.

Results Reference

background

PubMed Identifier

23314603

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.

Results Reference

background

PubMed Identifier

21465325

Citation

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.

Results Reference

background

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

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