AKY15-HK-301_NEPA Study

NCT ID: NCT03386617

Last Updated: 2024-12-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-27
• Study Completion Date: 2026-12-31

Brief Summary

Nausea and vomiting (feeling sick to your stomach and throwing up) are two of the most common unpleasant side effects of chemotherapy agents (drugs specifically used to treat cancer) that will be used for cancer treatment. If nausea and vomiting are not controlled, they could lead to dehydration, poor nutrition and a longer time in the hospital. Nausea and vomiting usually occur in response to conditions that affect the gut and the vomiting center, which is an area in the brain.

Netupitant and palonosetron are drugs that are thought to block the activation of certain types of chemicals in these areas (brain and gut) and, therefore, to prevent or reduce the severity of nausea and vomiting. Nausea and vomiting caused by chemotherapy is classified into two patterns based on the time of onset or start. Acute nausea and vomiting start within 24 hours of chemotherapy administration. Delayed nausea and vomiting starts approximately 2-5 days after chemotherapy administration. Regardless of when the nausea and vomiting start, these symptoms are usually treated with not just one drug, but a combination of drugs. In this study you will receive the study drug, which is a fixed combination of netupitant and palonosetron.

This is an open label single arm study. The main purpose of this study or clinical trial is to learn more about the effect (how well it works) of the fixed combination of netupitant and palonosetron (NEPA) in preventing nausea and vomiting associated with chemotherapy in Hong Kong oncology patients receiving (neo)-adjuvant chemotherapy treatment consists of adriamycin and cyclophosphamide for breast cancer.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NEPA

Day 1 of each chemotherapy cycle:

1 tablet of NEPA (NETU 300 mg/ PALO 0.50 mg) 1 hour prior to the start of chemotherapy with dexamethasone 12 mg administered orally 30 minutes prior to chemotherapy Days 2 to 3 Dexamethasone. The time and date of intake will be recorded.

Group Type: EXPERIMENTAL

NEPA

Intervention Type: DRUG

Day 1 of each chemotherapy cycle:

1 tablet of NEPA (NETU 300 mg/ PALO 0.50 mg) 1 hour prior to the start of chemotherapy with dexamethasone 12 mg administered orally 30 minutes prior to chemotherapy Days 2 to 3 Dexamethasone. The time and date of intake will be recorded.

Interventions

NEPA

Day 1 of each chemotherapy cycle:

1 tablet of NEPA (NETU 300 mg/ PALO 0.50 mg) 1 hour prior to the start of chemotherapy with dexamethasone 12 mg administered orally 30 minutes prior to chemotherapy Days 2 to 3 Dexamethasone. The time and date of intake will be recorded.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Adult patients ( ≥ 18 and <75 years), female; a. Chinese patient, female ≥18 and < 75 years of age.
• Patient is diagnosed with early breast cancer.
• Patient is scheduled to receive her first course of (neo)- adjuvant chemotherapy for breast cancer follows:
• IV adriamycin 60 mg/m2 + cyclophosphamide 600 mg/m2
• ECOG Performance Status of 0-1;
• Written informed consent before study entry;
• If women of childbearing potential age: reliable contraceptive measures are to be used during all the planned course of the study;
• Ability and willingness of the patient to complete the diary and study questionnaires.

Exclusion Criteria

• Any investigational drugs taken within 4 weeks prior to Day 1 of cycle 1, and/or is scheduled to receive any investigational drug during the study;
• Patients who are scheduled to receive concurrent radiation as part of their chemotherapy regimen for their malignancy;
• Patients who experience any vomiting or grade 2-3 nausea per Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v 4.03) in the 24 hours before Day 1 of chemotherapy;
• Patients who have taken any of the following agents within 7 calendar days prior to initiation of their chemotherapy regimen: 5-HT3 receptor antagonists, phenothiazines, benzamides, cannabinoids, NK1 receptor antagonists, corticosteroids, or benzodiazepines;
• Pregnant or breast-feeding women;
• Patient's inability to take oral medication;
• Gastrointestinal obstruction or active peptic ulcer;
• Psychiatric or CNS disorders interfering with ability to comply with study protocol;
• Patients at risk for severe cardiac/cardiovascular disorders
• Patients with myocardial infarction within 6 months

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Princess Margaret Hospital, Hong Kong

OTHER_GOV

Sponsor Role: collaborator

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

CCTU

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Winnie Yeo, MD, FRCP

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

Department of Clinical Oncology, Prince of Wales Hospital

Hong Kong, , Hong Kong

Countries

Hong Kong

References

Yeo W, Lau TK, Kwok CC, Lai KT, Chan VT, Li L, Chan V, Wong A, Soo WM, Yeung EW, Wong KH, Tang NL, Suen JJ, Mo FK. NEPA efficacy and tolerability during (neo)adjuvant breast cancer chemotherapy with cyclophosphamide and doxorubicin. BMJ Support Palliat Care. 2022 Jul;12(e2):e264-e270. doi: 10.1136/bmjspcare-2019-002037. Epub 2020 Jan 29.

Reference Type: DERIVED

PMID: 31996363 (View on PubMed)

Other Identifiers

SYM011

Identifier Type: -

Identifier Source: org_study_id