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临床试验/NCT03606369
NCT03606369Unknown2 期

Effectiveness and Quality of Life Analysis of Palonosetron Against Ondansetron Combined With Dexamethasone and Fosaprepitant in Prevention of Acute and Delayed Emesis Associated to Chemotherapy Moderate and Highly Emetogenic in Breast Cancer.

Instituto Nacional de Cancerologia de Mexico1 个研究点 分布在 1 个国家目标入组 560 人开始时间: 2015年11月5日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
发起方
入组人数
560
试验地点
1
主要终点
Acute nausea control

研究概览

简要总结

Nausea and vomiting are common complications on the chemotherapy (CT) and can affect the quality of life (QoL) of the patients. If not treated adequately it can produce other problems such as dehydration, weight loss, fatigue and even can induce the non-compliance of the treatment. In extreme cases it can put the patient ́s life at risk. There are various antiemetic treatments that vary both in cost and effectiveness. It ́s important to determine which are the strategies that are most effective and can improve the QoL of the patients.

Methodology:

The analysis will be done in patients who receive adjuvant and neoadjuvant chemotherapy and that have not received previously chemotherapy or radiotherapy, they will be stratified according to the emetogenic potential of the CT. They were given a diary of symptoms to register any discomfort suffered after receiving their treatment and also a quality of life questionnaire was applied previous to their first cycle and previous to their second cycle.

The patients were divided in two groups receiving either A scheme (palonosetron) or B scheme (ondansetron) in combination with dexamethasone and fosaprepitant for prevention of early emesis and Dexamethasone to group A or Dexamethasone + metoclopramide to group B for prevention of delayed emesis. As well It was analyzed the three most prevalent single nucleotide polymorphisms (SNPs) on gene ABCB1 using PCR.

The aim of this study is to evaluate the efficacy and quality of life provided by the 2 regimes noted above based on Mexican population so the results obtained can be applied widely in our country.

详细描述

Nausea and vomiting are common complications on the chemotherapy (CT) and can affect the quality of life (QoL) of the patients. If not treated adequately Nausea and vomiting can produce other problems such as dehydration, weight loss, fatigue and even can induce the non-compliance of the treatment. In extreme cases it can put the patient ́s life at risk. There are various antiemetic treatments that vary both in cost and effectiveness. It ́s important to determine which are the strategies that are most effective and can improve the QoL of the patients.

Methodology:

Effectiveness and quality of life analysis of patients with breast cancer that will receive adjuvant and neoadjuvant chemotherapy highly and moderately emetic chemotherapy (adriamycin and cyclophosphamide (AC), docetaxel and carboplatin (TC), docetaxel, carboplatin and trastuzumab (THC)); there will only be consider those patients that are candidates to receive CT for the first time and should have central venous access. There will be excluded patients that had received previously any kind of chemotherapy or radiotherapy. The follow-up will exclusively be done during the first cycle of CT. Patients will be stratified according to the emetogenic potential of the CT regimen ad not by the clinical stage or the histologic type of the tumor.

To keep a follow-up of the patient there will be provided symptomatic diaries where the patient can register any discomfort suffered after receiving their treatment. Along with this, there will be applied quality of life questionnaires, one previous to the CT and one previous to the second cycle.

There a proposed two regimes on antiemetic treatment. The randomization is as follows.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients 18 years old or more.
  • Not metastatic breast cancer confirmed with biopsy.
  • Candidates to receive chemotherapy with anthracyclines combined with cyclophosphamide or carboplatin combined with docetaxel or docetaxel combined with cyclophosphamide.
  • No previous treatment with radiotherapy or chemotherapy.
  • Adequate hematologic function (Hb >10 gr/dl, neutrophils >1500, platelets >100,000,) renal (Creatinine <1.2 or creatinine depuration >60 ml/min), hepatic (liver enzymes <2.5 their normal value) and cardiologic (electrocardiogram).
  • Adequate physical state (ECOG 0-1)
  • Patients that accept to enter in protocol and sign the informed consent.

排除标准

  • Prolonged QT (>480 mseg)
  • Comorbidities of the airway
  • Intolerance to swallow medications

研究组 & 干预措施

Palonosetron

Experimental

Early emesis: Palonosetron 0.25 mg IV + Dexamethasone 12 mg IV + Fosaprepitant 150 mg IV.

Delayed emesis: Dexamethasone 8 mg orally on days 2, 3 and 4.

干预措施: Palonosetron (Drug)

Ondansetron

Active Comparator

Early emesis: Ondansetron 16 mg IV + Dexamethasone 12 mg IV + Fosaprepitant 150 mg IV.

Delayed emesis: Metoclopramide 10 mg orally every 6 hours + Dexamethasone 8 mg orally every 24 hrs.

干预措施: Ondansetron (Drug)

结局指标

主要结局

Acute nausea control

时间窗: Within the first 24 hours after first dose of chemotherapy

Personal diary of symptoms given to the patient

次要结局

  • Delayed nausea control(Between 24 and 120 hours after first dose of chemotherapy)

研究者

发起方
Instituto Nacional de Cancerologia de Mexico
申办方类型
Other
责任方
Principal Investigator
主要研究者

Claudia Arce-Salinas

Attendin physician

Instituto Nacional de Cancerologia de Mexico

研究点 (1)

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