Chemotherapy Induced Nausea Vomiting Clinical Trial
Official title:
Fixed Dose Combination of Netupitant and Palonosetron (Akynzeo®) in the Treatment of Refractory Chemotherapy-Induced Nausea and Vomiting
Prevention and control of Chemotherapy-Induced Nausea and Vomiting (CINV) are most important in treatment of cancer patients. CINV is one of the most distressing severe side effects of cancer treatment and can have a significant impact on a patient's quality of life. The chemotherapy agents that cause the worst degree of nausea and vomiting are categorized into two groups: moderately emetogenic chemotherapy (MEC) and highly emetogenic chemotherapy (HEC). Nausea and vomiting that occurs within the first day of the administration of chemotherapy agents is considered acute CINV, while nausea and vomiting following 24 hours of the administration of chemotherapy agents is considered delayed CINV. Refractory CINV occurs when patients develop CINV during subsequent cycles of chemotherapy when drugs preventing vomiting and nausea (antiemetic prophylaxis) has not been successful in controlling CINV in earlier cycles. The purpose of this study is to assess the efficacy of Akynzeo in the treatment of refractory CINV
This is a Phase II, single-center, single-arm, open-label, feasibility trial using a fixed
dose combination of netupitant and palonosetron (Akynzeo®) in the treatment of refractory
CINV. The primary aim of this study is feasibility, defined as 70% completion rate of all
study procedures over 7 days.
Eligible subjects will be identified in weekly palliative care patient triage meetings.
Patients who are 18 years of age or older, have histologically confirmed cancer, and
confirmed refractory CINV will be eligible. After obtaining written informed consent and
verifying that the study subject meets all eligibility criteria, the subject will be enrolled
in the study through the University California San Diego (UCSD) Moores Cancer Center Clinical
Trials Office. Subjects will be allowed to participate only once in the study. Study Day 1
will be the day of Akynzeo® dosing. Subjects will receive a single capsule of Akynzeo® (300
mg of netupitant and 0.5 mg of palonosetron) on Study 1. Study drug may be taken with or
without food. Subjects will complete a study drug diary to document date and time of Akynzeo®
administration. On Study Day 1, the study coordinator will educate the subject on how to
complete the Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool,
and Functional Living Index Emesis (FLIE) scale, and medication diary and each of these
documents will be completed for that day. An adequate number of copies of each subject
questionnaire and diary will be provided to the subject on Study Day 1 for completion at home
during the post-treatment observation portion of the study (Study Days 2-7) as needed.
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