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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.

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ClinicalTrials.gov Identifier: NCT03606369
Recruitment Status : Recruiting
First Posted : July 30, 2018
Last Update Posted : July 30, 2018
Sponsor:
Information provided by (Responsible Party):
Claudia Arce-Salinas, Instituto Nacional de Cancerologia de Mexico

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Breast Neoplasm Antineoplastic Agents Antiemetics Quality of Life Drug: Palonosetron Drug: Ondansetron Phase 2 Phase 3

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 560 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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.
Actual Study Start Date : November 5, 2015
Actual Primary Completion Date : July 1, 2018
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Palonosetron

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.

 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.
Active Comparator: Ondansetron

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.

 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.


Outcome Measures
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Primary Outcome Measures :
  1. Acute nausea control [ Time Frame: Within the first 24 hours after first dose of chemotherapy ]
    Personal diary of symptoms given to the patient


Secondary Outcome Measures :
  1. Delayed nausea control [ Time Frame: Between 24 and 120 hours after first dose of chemotherapy ]
    Personal diary of symptoms given to the patient


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Prolonged QT (>480 mseg)
  • Comorbidities of the airway
  • Intolerance to swallow medications
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03606369


Contacts
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Contact: Claudia H Arce Salinas, MD 56280400 ext 12065 c.arce.salinas@gmail.com
Contact: Juan P González Serrano, BD 5519480352 jpablogs_9@hotmail.com

Locations
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Mexico
Instituto Nacional de Cancerología Recruiting
Mexico City, Mexico, 14080
Contact: Julieta Santamaría Galicia, BD    56280400 ext 12065    ztinala@yahoo.es   
Sponsors and Collaborators
Instituto Nacional de Cancerologia de Mexico
Investigators
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Principal Investigator: Claudia H Arce Salinas, MD
More Information
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Additional Information:
National Comprehensive Cancer Network  This link exits the ClinicalTrials.gov site

Publications of Results:

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Responsible Party: Claudia Arce-Salinas, Attendin physician, Instituto Nacional de Cancerologia de Mexico
ClinicalTrials.gov Identifier: NCT03606369    
Other Study ID Numbers: CE1002/15
First Posted: July 30, 2018    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Claudia Arce-Salinas, Instituto Nacional de Cancerologia de Mexico:
Breast Neoplasm
Antiemetics
Quality of Life
Palonosetron
Ondansetron
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Dexamethasone
Dexamethasone acetate
Ondansetron
Palonosetron
Fosaprepitant
Aprepitant
Emetics
BB 1101
Anti-Inflammatory Agents
Antiemetics
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antipruritics
Dermatologic Agents
Serotonin Antagonists