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 | Unknown Phase 2

• 1 other identifier: CE1002/15
• Study Type: interventional
• Target: 560
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasm; Antineoplastic Agents; Antiemetics; Quality of Life

Keywords

Breast Neoplasm; Antiemetics; Quality of Life; Palonosetron; Ondansetron

Outcome Measures

Primary Outcomes (1)

• Acute nausea control

  Personal diary of symptoms given to the patient

  Within the first 24 hours after first dose of chemotherapy

Secondary Outcomes (1)

• Delayed nausea control

  Between 24 and 120 hours after first dose of chemotherapy

Study Arms (2)

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.

Drug: Palonosetron

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.

Drug: Ondansetron

Interventions

Palonosetron DRUG

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.

Palonosetron

Ondansetron DRUG

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.

Ondansetron

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Instituto Nacional de Cancerologia de Mexico: lead

Study Sites (1)

Instituto Nacional de Cancerología

Mexico City, 14080, Mexico

RECRUITING

Related Publications (21)

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MeSH Terms

Conditions

Breast Neoplasms

Interventions

Palonosetron; Ondansetron

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Carbazoles; Indoles; Heterocyclic Compounds, 3-Ring

Study Officials

• Claudia H Arce Salinas, MD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claudia H Arce Salinas, MD

CONTACT

56280400; c.arce.salinas@gmail.com

Juan P González Serrano, BD

CONTACT

5519480352; jpablogs_9@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attendin physician

Study Record Dates

• First Submitted: July 3, 2018
• First Posted: July 30, 2018
• Study Start: November 5, 2015
• Primary Completion: July 1, 2018
• Study Completion: December 31, 2020
• Last Updated: July 30, 2018

Record last verified: 2018-07

Locations

ME (1)