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.
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03606369 |
|
Recruitment Status : Unknown
Verified July 2018 by Claudia Arce-Salinas, Instituto Nacional de Cancerologia de Mexico.
Recruitment status was: Recruiting
First Posted : July 30, 2018
Last Update Posted : July 30, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
Show detailed description
| 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 |
| 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. |
- Acute nausea control [ Time Frame: Within the first 24 hours after first dose of chemotherapy ]Personal diary of symptoms given to the patient
- Delayed nausea control [ Time Frame: Between 24 and 120 hours after first dose of chemotherapy ]Personal diary of symptoms given to the patient
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
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
| 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 |
| Mexico | |
| Instituto Nacional de Cancerología | Recruiting |
| Mexico City, Mexico, 14080 | |
| Contact: Julieta Santamaría Galicia, BD 56280400 ext 12065 ztinala@yahoo.es | |
| Principal Investigator: | Claudia H Arce Salinas, MD |
Publications of Results:
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
|
Breast Neoplasm Antiemetics Quality of Life Palonosetron Ondansetron |
|
Breast Neoplasms Neoplasms Neoplasms by Site Breast Diseases Skin Diseases Ondansetron Palonosetron Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents |
Antipruritics Dermatologic Agents Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Anti-Anxiety Agents Serotonin 5-HT3 Receptor Antagonists |