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.

NCT ID: NCT03606369

Last Updated: 2018-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

560 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-05

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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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.

Group A 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.

Group B 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.

Considering the absence of at least one event of nausea and vomiting as a measure of effectiveness, it will be calculated the effectiveness ratio, as well as the QoL questionnaires before and after the first chemotherapy.

Finally, previously to the application of the treatment there will be obtained a peripheral blood sample for its analysis on translational medicine laboratory. There will be a process of extraction of Deoxyribonucleic Acid accordingly to the guides and the sample will be analyzed by a protein chain reaction (PCR) to detect the three most prevalent polymorphisms (SNPs)on gene ABCB1.

H0: There ́s no difference in cost - effectiveness ratio in antiemetic therapy (acute and delayed) between A and B schemes.

H1: Scheme A is superior than scheme B in 10 % for prevention of acute nausea and vomiting and 6% in delayed nausea and vomiting.

Applications:

The guides that are actually used for the antiemetic treatments are based in non Mexican populations. With this study it is expected to design an effective strategy that can be applied in mexican population

Conditions

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Breast Neoplasm Antineoplastic Agents Antiemetics Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Palonosetron

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Ondansetron

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Instituto Nacional de Cancerologia de Mexico

OTHER

Sponsor Role lead

Responsible Party

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Claudia Arce-Salinas

Attendin physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Claudia H Arce Salinas, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

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Instituto Nacional de Cancerología

Mexico City, , Mexico

Site Status RECRUITING

Countries

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Mexico

Central Contacts

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Claudia H Arce Salinas, MD

Role: CONTACT

56280400 ext. 12065

Juan P González Serrano, BD

Role: CONTACT

5519480352

Facility Contacts

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Julieta Santamaría Galicia, BD

Role: primary

56280400 ext. 12065

References

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Other Identifiers

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CE1002/15

Identifier Type: -

Identifier Source: org_study_id

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