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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.

NCT03606369 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 560

Last updated 2018-07-30

No results posted yet for this study

Summary

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.

Conditions

  • Breast Neoplasm
  • Antineoplastic Agents
  • Antiemetics
  • Quality of Life

Interventions

DRUG

Palonosetron

Palonosetron 0.25 mg IV + Dexamethasone 12 mg IV + Fosaprepitant 150 mg IV for early emesis and for delayed emesis Dexamethasone 8 mg orally on days 2, 3 and 4.

DRUG

Ondansetron

Early emesis: Ondansetron 16 mg IV + Dexamethasone 12 mg IV + Fosaprepitant 150 mg IV. and for delayed emesis: Metoclopramide 10 mg orally every 6 hours + Dexamethasone 8 mg orally every 24 hrs.

Sponsors & Collaborators

  • Instituto Nacional de Cancerologia de Mexico

    lead OTHER

Principal Investigators

  • Claudia H Arce Salinas, MD

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-05
Primary Completion
2018-07-01
Completion
2020-12-31

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03606369 on ClinicalTrials.gov