Breast NeoplasmPhase 2/3NCT03606369
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.
A Phase 2/3 study testing Palonosetron and Ondansetron in people with Breast Neoplasm and Antineoplastic Agents, run by Instituto Nacional de Cancerologia de Mexico at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasm, Antineoplastic Agents, Antiemetics
- What is being tested?
- Palonosetron and Ondansetron
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- 1 siteMexico
- Study dates
- 5 Nov 2015to 31 Dec 2020
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Prolonged QT (>480 mseg)
- Comorbidities of the airway
- Intolerance to swallow medications
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Instituto Nacional de Cancerología
Mexico City, 14080
Julieta Santamaría Galicia, BD, 56280400 ext. 12065, ztinala@yahoo.es
About this study
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:
Read more
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.
Read the detailed 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
- Conditions
- Breast Neoplasm, Antineoplastic Agents, Antiemetics, Quality of Life
- Being tested
- Palonosetron, Ondansetron
- Keywords
- Breast Neoplasm, Antiemetics, Quality of Life, Palonosetron, Ondansetron
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PalonosetronDrug
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.
OndansetronDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Ondansetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute nausea control
Personal diary of symptoms given to the patient
Measured: Within the first 24 hours after first dose of chemotherapy
Secondary outcomes (1)
Delayed nausea control
Personal diary of symptoms given to the patient
Measured: Between 24 and 120 hours after first dose of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study start5 Nov 2015
- Primary completion1 Jul 2018
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cancerologia de Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Arce-Salinas, Instituto Nacional de Cancerologia de Mexico
- Investigators
- Claudia H Arce Salinas, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03606369
- Sponsor's protocol ID
- CE1002/15
- Status last verified
- Jul 2018
- First submitted
- 3 Jul 2018
- Last updated
- 30 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Coates A, Abraham S, Kaye SB, Sowerbutts T, Frewin C, Fox RM, Tattersall MH. On the receiving end--patient perception of the side-effects of cancer chemotherapy. Eur J Cancer Clin Oncol. 1983 Feb;19(2):203-8. doi: 10.1016/0277-5379(83)90418-2.
PubMed 6681766Craig JB, Powell BL. The management of nausea and vomiting in clinical oncology. Am J Med Sci. 1987 Jan;293(1):34-44. doi: 10.1097/00000441-198701000-00008.
PubMed 3544842Passik SD, Kirsh KL, Rosenfeld B, McDonald MV, Theobald DE. The changeable nature of patients' fears regarding chemotherapy: implications for palliative care. J Pain Symptom Manage. 2001 Feb;21(2):113-20. doi: 10.1016/s0885-3924(00)00249-9.
PubMed 11226762Hesketh PJ. Chemotherapy-induced nausea and vomiting. N Engl J Med. 2008 Jun 5;358(23):2482-94. doi: 10.1056/NEJMra0706547. No abstract available.
PubMed 18525044Grunberg SM, Warr D, Gralla RJ, Rapoport BL, Hesketh PJ, Jordan K, Espersen BT. Evaluation of new antiemetic agents and definition of antineoplastic agent emetogenicity--state of the art. Support Care Cancer. 2011 Mar;19 Suppl 1:S43-7. doi: 10.1007/s00520-010-1003-x. Epub 2010 Oct 24.
PubMed 20972805Hatoum 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.
PubMed 21533811Grunberg 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.
PubMed 15139073Wickham R. Evolving treatment paradigms for chemotherapy-induced nausea and vomiting. Cancer Control. 2012 Apr;19(2 Suppl):3-9. doi: 10.1177/107327481201902s02.
PubMed 22488022Schnell FM. Chemotherapy-induced nausea and vomiting: the importance of acute antiemetic control. Oncologist. 2003;8(2):187-98. doi: 10.1634/theoncologist.8-2-187.
PubMed 12697943Vargas-Alarcon G, Ramirez-Bello J, de la Pena A, Calderon-Cruz B, Pena-Duque MA, Martinez-Rios MA, Ramirez-Fuentes S, Perez-Mendez O, Fragoso JM. Distribution of ABCB1, CYP3A5, CYP2C19, and P2RY12 gene polymorphisms in a Mexican Mestizos population. Mol Biol Rep. 2014 Oct;41(10):7023-9. doi: 10.1007/s11033-014-3590-y. Epub 2014 Aug 9.
PubMed 25106522Kimchi-Sarfaty C, Marple AH, Shinar S, Kimchi AM, Scavo D, Roma MI, Kim IW, Jones A, Arora M, Gribar J, Gurwitz D, Gottesman MM. Ethnicity-related polymorphisms and haplotypes in the human ABCB1 gene. Pharmacogenomics. 2007 Jan;8(1):29-39. doi: 10.2217/14622416.8.1.29.
PubMed 17187507Siddiqui A, Kerb R, Weale ME, Brinkmann U, Smith A, Goldstein DB, Wood NW, Sisodiya SM. Association of multidrug resistance in epilepsy with a polymorphism in the drug-transporter gene ABCB1. N Engl J Med. 2003 Apr 10;348(15):1442-8. doi: 10.1056/NEJMoa021986.
PubMed 12686700Tsuji D, Kim YI, Nakamichi H, Daimon T, Suwa K, Iwabe Y, Hayashi H, Inoue K, Yoshida M, Itoh K. Association of ABCB1 polymorphisms with the antiemetic efficacy of granisetron plus dexamethasone in breast cancer patients. Drug Metab Pharmacokinet. 2013;28(4):299-304. doi: 10.2133/dmpk.dmpk-12-rg-084. Epub 2013 Jan 29.
PubMed 23358260He H, Yin JY, Xu YJ, Li X, Zhang Y, Liu ZG, Zhou F, Zhai M, Li Y, Li XP, Wang Y, Zhou HH, Liu ZQ. Association of ABCB1 polymorphisms with the efficacy of ondansetron in chemotherapy-induced nausea and vomiting. Clin Ther. 2014 Aug 1;36(8):1242-1252.e2. doi: 10.1016/j.clinthera.2014.06.016. Epub 2014 Jul 8.
PubMed 25012726al-Idrissi HY, Ibrahim EM, Abdullah KA, Ababtain WA, Boukhary HA, Macaulay HM. Antiemetic efficacy of high-dose dexamethasone: randomized, double-blind, crossover study with a combination of dexamethasone, metoclopramide and diphenhydramine. Br J Cancer. 1988 Mar;57(3):308-12. doi: 10.1038/bjc.1988.68.
PubMed 3281702
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03606369
- Acronym / sponsor ID
- CE1002/15
- Conditions
- Breast Neoplasm, Antineoplastic Agents, Antiemetics, Quality of Life
- Keywords
- Breast Neoplasm, Antiemetics, Quality of Life, Palonosetron, Ondansetron
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- Instituto Nacional de Cancerologia de MexicoUniversity, hospital or other
- Study start
- 5 Nov 2015 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 30 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Palonosetron | Experimental | Drug: PalonosetronEarly 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. |
| Ondansetron | Active comparator | Drug: OndansetronEarly 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (3 listed)
- Prolonged QT (>480 mseg)
- Comorbidities of the airway
- Intolerance to swallow medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PalonosetronPalonosetron 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. | Drug | Palonosetron |
| OndansetronEarly 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. | Drug | Ondansetron |
Primary outcome
Acute nausea control
Time frame: Within the first 24 hours after first dose of chemotherapy
Personal diary of symptoms given to the patient
1 secondary outcome
Delayed nausea control
Time frame: Between 24 and 120 hours after first dose of chemotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2018.
- Results publication: PubMed 6681766Coates A, Abraham S, Kaye SB, Sowerbutts T, Frewin C, Fox RM, Tattersall MH. On the receiving end--patient perception of the side-effects of cancer chemotherapy. Eur J Cancer Clin Oncol. 1983 Feb;19(2):203-8. doi: 10.1016/0277-5379(83)90418-2.
- Results publication: PubMed 3544842Craig JB, Powell BL. The management of nausea and vomiting in clinical oncology. Am J Med Sci. 1987 Jan;293(1):34-44. doi: 10.1097/00000441-198701000-00008.
- Results publication: PubMed 11226762Passik SD, Kirsh KL, Rosenfeld B, McDonald MV, Theobald DE. The changeable nature of patients' fears regarding chemotherapy: implications for palliative care. J Pain Symptom Manage. 2001 Feb;21(2):113-20. doi: 10.1016/s0885-3924(00)00249-9.
- Results publication: PubMed 18525044Hesketh PJ. Chemotherapy-induced nausea and vomiting. N Engl J Med. 2008 Jun 5;358(23):2482-94. doi: 10.1056/NEJMra0706547. No abstract available.
- Results publication: PubMed 20972805Grunberg SM, Warr D, Gralla RJ, Rapoport BL, Hesketh PJ, Jordan K, Espersen BT. Evaluation of new antiemetic agents and definition of antineoplastic agent emetogenicity--state of the art. Support Care Cancer. 2011 Mar;19 Suppl 1:S43-7. doi: 10.1007/s00520-010-1003-x. Epub 2010 Oct 24.
- Results publication: PubMed 21533811Hatoum 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.
- Results publication: PubMed 15139073Grunberg 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.
- Results publication: PubMed 22488022Wickham R. Evolving treatment paradigms for chemotherapy-induced nausea and vomiting. Cancer Control. 2012 Apr;19(2 Suppl):3-9. doi: 10.1177/107327481201902s02.
- Results publication: PubMed 12697943Schnell FM. Chemotherapy-induced nausea and vomiting: the importance of acute antiemetic control. Oncologist. 2003;8(2):187-98. doi: 10.1634/theoncologist.8-2-187.
- Results publication: PubMed 25106522Vargas-Alarcon G, Ramirez-Bello J, de la Pena A, Calderon-Cruz B, Pena-Duque MA, Martinez-Rios MA, Ramirez-Fuentes S, Perez-Mendez O, Fragoso JM. Distribution of ABCB1, CYP3A5, CYP2C19, and P2RY12 gene polymorphisms in a Mexican Mestizos population. Mol Biol Rep. 2014 Oct;41(10):7023-9. doi: 10.1007/s11033-014-3590-y. Epub 2014 Aug 9.
- Results publication: PubMed 17187507Kimchi-Sarfaty C, Marple AH, Shinar S, Kimchi AM, Scavo D, Roma MI, Kim IW, Jones A, Arora M, Gribar J, Gurwitz D, Gottesman MM. Ethnicity-related polymorphisms and haplotypes in the human ABCB1 gene. Pharmacogenomics. 2007 Jan;8(1):29-39. doi: 10.2217/14622416.8.1.29.
- Results publication: PubMed 12686700Siddiqui A, Kerb R, Weale ME, Brinkmann U, Smith A, Goldstein DB, Wood NW, Sisodiya SM. Association of multidrug resistance in epilepsy with a polymorphism in the drug-transporter gene ABCB1. N Engl J Med. 2003 Apr 10;348(15):1442-8. doi: 10.1056/NEJMoa021986.
- National Comprehensive Cancer NetworkLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia H Arce Salinas, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Palonosetron and Ondansetron in people with Breast Neoplasm and Antineoplastic Agents, run by Instituto Nacional de Cancerologia de Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claudia H Arce Salinas, MD (56280400 ext. 12065, c.arce.salinas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute nausea control (time frame: Within the first 24 hours after first dose of chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03606369, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2018.