Chemotherapy-induced Nausea and Vomiting
Conditions
Keywords
nausea, vomiting, breast cancer, AC-based chemotherapy
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.
Interventions
Sponsors
Consorzio Oncotech
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Phase II study, one stage Fleming design, open-label, multicenter, not comparative
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Women ≥ 18 years old 2. Histologically or cytologically confirmed diagnosis of breast cancer 3. Naïve patients 4. Be scheduled to receive adjuvant chemotherapy with anthracycline (doxorubicin or epirubicin) + cyclophosphamide (AC-based regimen) 5. ECOG (Eastern Cooperative Oncology Group) performance status 0-2 6. Body Mass index (BMI) ≥ 18.5 7. Written informed consent 8. 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 9. 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); 10. Ability and willingness of the patient to complete the diary.
Exclusion criteria
1. Advanced/metastatic breast cancer 2. Patients already submitted to non-AC-based chemotherapy 3. Treatment with investigational medications in 30 days before NEPA 4. Myocardial infarction within the last 6 months 5. Documented or known hypersensitivity to 5HT3RA (5-Hydroxytryptamine Receptor 3 Antagonists) or NK1RA (Neurokinin-1 Receptor Antagonists) and excipients 6. Uncontrolled diabetes mellitus 7. Nausea and vomiting at baseline 8. Chronic use of other antiemetic agent(s) 9. Patient's inability to take oral medication 10. Gastrointestinal obstruction or active peptic ulcer 11. Pregnancy or breastfeeding 12. Prior malignancies at other sites except surgically treated non-melanoma skin cancer, superficial cervical cancer, or other cancer from which the patient had been disease-free for ≥ 5 years 13. Psychiatric or CNS (Central Nervous System) disorders interfering with ability to comply with study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete response | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Rate of complete control (defined as complete response with a maximum grade of mild nausea) |
| 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 | Percentage of emesis-free patients (no emetic episodes) after any AC-based chemotherapy administration. |
| Acute and Delayed Phase Complete Response | During the Acute Phase [0-24 hours after chemotherapy (CT)] and the Delayed (25-120 hours) phase | Rate of complete control (defined as no emetic episode and no need for rescue medication) |
| 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 | Patient global satisfaction with antiemetic therapy, as measured by a Visual Analogue Scale (VAS). Scale ranges are 0-10 (0 represents maximum dissatisfaction, 10 represents maximum satisfaction) |
| 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 | Safety profile according to CTCAE |
| 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 | Presence of nausea graded according to Likert scale (none, mild, moderate and severe) |
Outcome results
None listed