Netupitant and Palonosetron Hydrochloride in Preventing Chronic Nausea and Vomiting in Patients With Cancer
Fixed-Dose Netupitant and Palonosetron for Chronic Nausea and Vomiting in Cancer Patients
2 other identifiers
interventional
53
1 country
1
Brief Summary
This randomized phase II/III trial studies how well netupitant and palonosetron hydrochloride works in preventing chronic nausea and vomiting in patients with cancer. Netupitant and palonosetron hydrochloride may reduce nausea and vomiting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2017
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2017
CompletedFirst Posted
Study publicly available on registry
February 2, 2017
CompletedStudy Start
First participant enrolled
May 3, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 14, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 14, 2022
CompletedResults Posted
Study results publicly available
October 17, 2023
CompletedOctober 17, 2023
September 1, 2023
4.8 years
January 31, 2017
February 7, 2023
September 25, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Nausea Numerical Rating Scale (NRS) Between Day 5 and Day 15
Average intensity of nausea over the past 24 hours was assessed daily using a validated numeric rating scale from 0 to 10, where 0= none and 10= worse possible nausea. The total score ranged from 0-10. We measured the within-group change in nausea intensity from day 5 to day 15. Wilcoxon rank sum test was used for analysis.
Day 5 and Day 15
Secondary Outcomes (3)
Functional Living Index Emesis (FLIE): Nausea Sub-score
Baseline and Day 15
Functional Living Index Emesis (FLIE): Vomiting Sub-score
Baseline and Day 15
Index of Nausea, Vomiting and Retching: Total Experience Score
Day 5 and Day 15
Study Arms (2)
Group I (netupitant, palonosetron hydrochloride)
EXPERIMENTALPatients receive netupitant orally (PO) and palonosetron hydrochloride PO on days 1, 6, and 11 in the absence of disease progression or unacceptable toxicity.
Group II (placebo)
PLACEBO COMPARATORPatients receive placebo PO on days 1, 6, and 11.
Interventions
Given PO
Given PO
Ancillary studies
Eligibility Criteria
You may qualify if:
- Diagnosis of cancer
- Chronic nausea over the past 4 weeks
- Average nausea numeric rating scale \>= 4/10 over the past 5 days at screening
- Outpatient at MD Anderson Cancer Center
- Karnofsky performance status \>= 50%
- Age 18 or older
- Able to complete study assessments, including keeping a daily diary
You may not qualify if:
- Delirium (i.e. Memorial Delirium Rating Scale \> 13)
- Clinical evidence of bowel obstruction at the time of study enrollment
- Expected to use other 5HT3 antagonists or NK1 antagonists for prophylaxis during the study
- Continuation of over-the-counter therapies for nausea and/or vomiting during the study
- On cytotoxic chemotherapy in the high/moderate/low emetogenic risk categories or oral antineoplastic agents in the high or moderate emetogenic risk categories according to the latest National Comprehensive Cancer Network (NCCN) guideline within 2 weeks of study enrollment
- On scheduled potent CYP3A4 inducers at the time of study enrollment (avasimibe, carbamazepine, phenytoin, rifampin, efavirenz, nevirapine, barbiturates, systemic glucocorticoids, modafinil, oxcarbazine, phenobarbital, pioglitazone, rifabutin, St. John's wort, troglitazone)
- On scheduled CYP3A4 substrates with narrow safety range at the time of study enrollment (alfentanil, cyclosporine, dihydroergotamine, ergotamine, pimozide, quinidine, sirolimus, tacrolimus)
- On scheduled strong or moderate CYP3A4 inhibitors (boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole; amprenavir, aprepitant, atazanavir, ciprofloxacin, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, imatinib, verapamil) within one week of study enrollment
- Unwilling to provide informed consent
- Severe renal impairment (calculated creatinine clearance =\< 29 cc/min)
- Calculated creatinine clearance can be done within 14 days of study enrollment
- Severe liver impairment (Child-Pugh score \> 9)
- Total (T.) bilirubin, albumin, prothrombin time, and serum creatinine tests can be done within 14 days of study enrollment (only if not performed in the last 14 days)
- Females who are pregnant, lactating, or intend to become pregnant during the participation of the study; childbearing age women who are not on birth control; positive pregnancy test for women of childbearing potential, as defined by intact uterus and ovaries, and no history of menses within the last 12 months; pregnancy test to be performed on the day of enrollment; in cases of women with elevated beta-human chorionic gonadotropin (b-HCG), these candidates will be eligible to participate so long as the level of b-HCG is not consistent with pregnancy and the non-pregnant status is confirmed by a gynecologic examination
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
- Helsinn Healthcare SAcollaborator
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
Hui D, Puac V, Shelal Z, Liu D, Maddi R, Kaseb A, Javle M, Overman M, Yennurajalingam S, Gallagher C, Bruera E. Fixed-Dose Netupitant and Palonosetron for Chronic Nausea in Cancer Patients: A Double-Blind, Placebo Run-in Pilot Randomized Clinical Trial. J Pain Symptom Manage. 2021 Aug;62(2):223-232.e1. doi: 10.1016/j.jpainsymman.2020.12.023. Epub 2021 Jan 1.
PMID: 33388382DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. David Hui
- Organization
- The University of Texas MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
David Hui
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2017
First Posted
February 2, 2017
Study Start
May 3, 2017
Primary Completion
February 14, 2022
Study Completion
February 14, 2022
Last Updated
October 17, 2023
Results First Posted
October 17, 2023
Record last verified: 2023-09