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.

Quality of Life Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03606369
• Other study ID #: CE1002/15
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: November 5, 2015
• Est. completion date: December 31, 2020

Study information

• Verified date: July 2018
• Source: Instituto Nacional de Cancerologia de Mexico
• Contact: Claudia H Arce Salinas, MD
• Phone: 56280400
• Email: c.arce.salinas[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 560
• Est. completion date: December 31, 2020
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Cancerología	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Cancerologia de Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (21)

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* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute nausea control	Personal diary of symptoms given to the patient	Within the first 24 hours after first dose of chemotherapy
Secondary	Delayed nausea control	Personal diary of symptoms given to the patient	Between 24 and 120 hours after first dose of chemotherapy

External Links

•   National Comprehensive Cancer Network