NCT03862144
Completed
Phase 2
One Day Antiemetic Prophylaxis of NEPA (Netupitant Plus Palonosetron) and Dexamethasone to Prevent Chemotherapy-induced Nausea and Vomiting (CINV) in Breast Cancer Patients Receiving an AC-based Chemotherapy Regimen
ConditionsChemotherapy-induced Nausea and Vomiting
InterventionsNetupitant/Palonosetron
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Consorzio Oncotech
- Enrollment
- 150
- Primary Endpoint
- Complete response
Overview
Brief Summary
This study evaluates if the activity of one-day of NEPA plus dexamethasone, to prevent chemotherapy-induced nausea and vomiting in breast cancer patients receiving adjuvant AC-based chemotherapy, is maintained during all the chemotherapy cycle treatment (maximum 4 cycles).
Detailed Description
Patients included in the study should be treated with the following antiemetic prophylaxis, during all the AC-based chemotherapy cycles, up to a maximum of 4 cycles:
- NEPA will be administered orally at the dose of 300 mg netupitant/0.5 palonosetron 1 hour before the start of any chemotherapy cycle.
- Dexamethasone 12 mg will be added on day 1 only of each cycle.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Women ≥ 18 years old
- •Histologically or cytologically confirmed diagnosis of breast cancer
- •Naïve patients
- •Be scheduled to receive adjuvant chemotherapy with anthracycline (doxorubicin or epirubicin) + cyclophosphamide (AC-based regimen)
- •ECOG (Eastern Cooperative Oncology Group) performance status 0-2
- •Body Mass index (BMI) ≥ 18.5
- •Written informed consent
- •If women of childbearing potential age: reliable contraceptive measures must be used during the study treatment period and up to 30 days after last NEPA administration
- •Acceptable hepatic function (\<= 2 times the upper limit of normal for liver transaminases) and renal function (creatinine \< 1.5 times the upper limit of normal);
- •Ability and willingness of the patient to complete the diary.
Exclusion Criteria
- •Advanced/metastatic breast cancer
- •Patients already submitted to non-AC-based chemotherapy
- •Treatment with investigational medications in 30 days before NEPA
- •Myocardial infarction within the last 6 months
- •Documented or known hypersensitivity to 5HT3RA (5-Hydroxytryptamine Receptor 3 Antagonists) or NK1RA (Neurokinin-1 Receptor Antagonists) and excipients
- •Uncontrolled diabetes mellitus
- •Nausea and vomiting at baseline
- •Chronic use of other antiemetic agent(s)
- •Patient's inability to take oral medication
- •Gastrointestinal obstruction or active peptic ulcer
Arms & Interventions
Netupitant/Palonosetron & Dexamethasone
Experimental
- Netupitant/Palonosetron (NEPA) will be administered orally at the dose of 300 MG (milligrams) netupitant/0.5 palonosetron 1 hour before the start of any chemotherapy cycle.
- Dexamethasone 12 mg will be added on day 1 only of each cycle.
Intervention: Netupitant/Palonosetron (Drug)
Outcomes
Primary Outcomes
Complete response
Time Frame: During the overall phase (From day 1 to day 5 after any AC-based chemotherapy administration) for a maximum 4 cycles (each cycle is 21 days)
The rate of patients achieving and maintaining a complete response (defined as no emetic episode and no use of rescue medication) during the overall phase of all AC-based chemotherapy cycles
Secondary Outcomes
- Acute and Delayed Phase Complete Response(During the Acute Phase [0-24 hours after chemotherapy (CT)] and the Delayed (25-120 hours) phase)
- Complete Control(During the Acute Phase (0-24 hours after chemotherapy), the Delayed (25-120 hours), the Overall (0-120 hours) phases for each cycle and separately on single days of all chemotherapy cycles (each cycle is 21 days), up to 4 cycles)
- Emesis-Free(During the Acute (0-24 hours after CT), the Delayed (25-120 hours), the Overall (0-120 hours) phases for each cycle (each cycle is 21 days)and separately on single days of all CT cycles,up to 4 cycles.Also during the period between two consecutive cycles)
- Nausea(During the Acute (0-24 hours after CT), the Delayed (25-120 hours), the Overall (0-120 hours) phases for each cycle (of 21 days)and separately on single days of all chemotherapy cycles, up to 4 cycles.Also during the period between two consecutive cycles)
- Global satisfaction with antiemetic therapy: Visual Analogue Scale (VAS)(During the Acute Phase (0-24 hours after CT), the Delayed (25-120 hours), the Overall (0-120 hours) phases for each cycle (each cycle is 21 days) and separately on single days of all CT cycles, up to 4 cycles)
- Safety profile (according to CTCAE)(During the Acute Phase (0-24 hours after CT), the Delayed (25-120 hours), the Overall (0-120 hours) phases for each cycle (each cycle is 21 days) and separately on single days of all CT cycles, up to 4 cycles)
Investigators
Similar Trials
Active, not recruiting
Phase 1
One day antiemetic prophylaxis of NEPA (netupitant plus palonosetron) and dexamethasone to prevent chemotherapy-induced nausea and vomiting (CINV) in breast cancer patients receiving a combination chemotherapy of doxorubicin or epirubicin with cyclophosphamide (AC-based regimen)Chemotherapy-Induced Nausea and Vomiting (CINV) in breast cancer patients receiving a combination chemotherapy of doxorubicin or epirubicin with cyclophosphamide (AC-based regimen)MedDRA version: 20.0Level: LLTClassification code 10008443Term: Chemotherapy antiemetic prophylaxsisSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 21.1Level: PTClassification code 10054133Term: Prophylaxis of nausea and vomitingSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 21.1Level: LLTClassification code 10008448Term: Chemotherapy induced emesis prophylaxisSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 21.1Level: LLTClassification code 10049091Term: Chemotherapy antiemetic prophylaxisSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 21.1Level: LLTClassification code 10008449Term: Chemotherapy inducted emesis prophylaxisSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 21.1Level: LLTClassification code 10036899Term: Prophylaxis against chemotherapy induced vomitingSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Diseases [C] - Cancer [C04]EUCTR2015-003316-20-ITCONSORZIO ONCOTECH150
Not yet recruiting
Phase 3
sing medicine Fosaprepitant along with other anti-vomiting medications for better control of vomiting and nausea in children receiving chemotherapyCTRI/2023/12/060941Cancer Institute (WIA)
Recruiting
Phase 3
The effect of dexamethasone, droperidol and ginger on controlling nausea and vomitingIRCT20230506058101N1Arak University of Medical Sciences152
Unknown
Phase 3
Aprepitant for the Prevention of Chemotherapy-induced Nausea and VomitingChemotherapy-induced Nausea and VomitingNCT02933099Wuhan Union Hospital, China300
Recruiting
Not Applicable
The Safety and Effectiveness of NEPA in Preventing Postoperative Nausea and Vomiting After General Anesthesia Gastrointestinal Cancer Surgery: A Single-Center Retrospective StudyGeneral Anesthesia Gastrointestinal Cancer SurgeryNCT06417567Tianjin Medical University Cancer Institute and Hospital50