AKY15-HK-301_NEPA Study
Кључне речи
Апстрактан
Датуми
| Последња верификација: | 06/30/2020 |
| Фирст Субмиттед: | 11/21/2017 |
| Предвиђена пријава послата: | 12/27/2017 |
| Прво објављено: | 12/28/2017 |
| Послато последње ажурирање: | 07/07/2020 |
| Последње ажурирање објављено: | 07/09/2020 |
| Стварни датум почетка студије: | 02/26/2018 |
| Процењени датум примарног завршетка: | 12/30/2022 |
| Предвиђени датум завршетка студије: | 12/30/2022 |
Стање или болест
Интервенција / лечење
Drug: NEPA
Фаза
Групе руку
| Арм | Интервенција / лечење |
|---|---|
| Experimental: 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. | Drug: 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. |
Критеријуми
| Узраст подобан за студирање | 18 Years До 18 Years |
| Полови подобни за студирање | All |
| Прихвата здраве волонтере | да |
| Критеријуми | 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 |
Исход
Примарне мере исхода
1. To evaluate the proportion of patients with a Complete Response (CR), during the delayed phase (24-120 h post-chemotherapy) periods in cycle 1 by using patient diary [up to 84 days]
2. To evaluate the proportion of patients with Complete Protection during the delayed phase (24-120 h post-chemotherapy) periods in cycle 1 by using patient diary [up to 84 days]
Секундарне мере исхода
1. Complete Response during the acute (0-24 h) phase in Cycle 1 by using patient diary [6 days for every 3 weekly cycles. total 4 cycles, so time frame is 84 days]
2. Complete Response during the overall (0-120 h) phase in Cycle 1 by using patient diary [6 days for every 3 weekly cycles. total 4 cycles, so time frame is 84 days]
3. Complete Protection during the acute (0-24 h) phase in Cycle 1 by using patient diary [6 days for every 3 weekly cycles. total 4 cycles, so time frame is 84 days]
4. Complete Protection during the overall (0-120 h) phase in Cycle 1 by using patient diary [6 days for every 3 weekly cycles. total 4 cycles, so time frame is 84 days]
5. Total Control during the acute, delayed and overall phases of Cycle 1; The percentage of patients with Total Control during the acute delayed phase in cycle 1 will be summarized descriptively [6 days for every 3 weekly cycles. total 4 cycles, so time frame is 84 days]
6. Total Control during the acute, delayed and overall phases of Cycle 1; The percentage of patients with Total Control during overall phase in cycle 1 will be summarized descriptively [6 days for every 3 weekly cycles. total 4 cycles, so time frame is 84 days]
7. Healthcare resources utilization; The number of hospitalizations will be summarized descriptively [6 days for every 3 weekly cycles. total 4 cycles, so time frame is 84 days]
8. Evaluation of NEPA safety profile; Clinical evaluations for safety assessments will include monitoring AEs [6 days for every 3 weekly cycles. total 4 cycles, so time frame is 84 days]
9. To assess the impact of nausea and vomiting on patients' quality of life, the FILE (Functional Living Index-Emesis) with a 5-day recall will be used. [6 days for every 3 weekly cycles. total 4 cycles, so time frame is 84 days]
10. A total FLIE score (expressed in FLIE points) greater than 108 will be categorized as having no impact on daily life [6 days for every 3 weekly cycles. total 4 cycles, so time frame is 84 days]
