Clinical trial · Interventional
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Antiemetics | — | UNRESOLVED | — |
| Antineoplastic Agents | — | UNRESOLVED | — |
| Breast Neoplasm | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ondansetron | Drug | — | UNRESOLVED |
| Palonosetron | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Palonosetron
- description
- 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.
- interventionNames
- Drug: Palonosetron
- type
- ACTIVE_COMPARATOR
- label
- Ondansetron
- description
- 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.
- interventionNames
- Drug: Ondansetron
Primary outcomes (1)
- measure
- Acute nausea control
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (21)
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- RESULTHatoum HT, Lin SJ, Buchner D, Cox D. Comparative clinical effectiveness of various 5-HT3 RA antiemetic regimens on chemotherapy-induced nausea and vomiting associated with hospital and emergency department visits in real world practice. Support Care Cancer. 2012 May;20(5):941-9. doi: 10.1007/s00520-011-1165-1. Epub 2011 May 1. PMID 21533811
- RESULTGrunberg SM, Deuson RR, Mavros P, Geling O, Hansen M, Cruciani G, Daniele B, De Pouvourville G, Rubenstein EB, Daugaard G. Incidence of chemotherapy-induced nausea and emesis after modern antiemetics. Cancer. 2004 May 15;100(10):2261-8. doi: 10.1002/cncr.20230.