Chemotherapy-induced Nausea and Vomiting Clinical Trial
Official title:
Granisetron Extended Release Injection (GERSC) for the Prevention of Chemotherapy-induced Breakthrough Nausea and Vomiting (CINV) in Patients Receiving Moderately or Highly Emetogenic Chemotherapy: A Phase II Clinical Trial
Chemotherapy-induced nausea and vomiting (CINV) adversely affects patients' quality of life
and may affect patients' treatment decisions. The emetogenicity of the chemotherapy
administered and specific patient characteristics such as female gender, age, and history of
low alcohol intake can increase a patients' risk for CINV.
GERSC is a new, subcutaneously (SC) administered polymeric formulation of Granisetron that
was developed to provide slow, controlled, and sustained release of Granisetron to prevent
both acute and delayed CINV associated with moderately emetic chemotherapy (MEC) and highly
emetic chemotherapy (HEC)
All patients eligible for the study receiving moderately emetogenic (MEC) chemotherapy will
receive GERSC receptor antagonist on day one. All patients eligible for the study receiving
highly emetogenic Chemotherapy (HEC) chemotherapy will receive GERSC receptor antagonist on
day one including dexamethasone and NK-1 Receptor antagonist during cycle 1.
The primary objective is to measure the Complete Response (no emetic episodes, no use of
rescue medications) in patients receiving GERSC as a replacement for the second generation 5
HT3 receptor antagonist palonosetron used in the first chemotherapy cycle for those patients
receiving MEC or HEC and developed Breakthrough CINV. Complete response would be recorded
specifically for the acute (0-24 hours post-chemotherapy), delayed (24-120 hours
post-chemotherapy), and overall periods (0-120 hours post-chemotherapy).
This study has two study groups.
- Group 1 (HEC) will receive GERSC, dexamethasone and NK-1 antagonist prior to
chemotherapy
- Group 2 (MEC) will receive GERSC and dexamethasone prior to chemotherapy
During the study:
Participants will be completing questionnaires on day 1 prior to treatment and at
approximately the same time treatment was given each day for the next seven days. Participant
will be assessed each day on the amount of nausea, vomiting, and/or sedation experienced in
the previous 24-hour period. The assessment should take less than 5 minutes to complete each
day.
Participants will be registered for Quality of Life measurement. Validated QOL measurements
of fatigue and overall perception of QOL will be assessed upon registration in this study.
Fatigue and overall well-being clearly can impact how well patients will do in terms of being
able to tolerate and experience nausea and vomiting
;
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