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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
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 MEC and HEC. Due to the prolonged efficacy, GERSC may potentially improve CINV in the acute and delayed periods and the single dose regimen may improve patient adherence to antiemetic therapy
The University of Alabama at Birmingham
Birmingham, Alabama, United States
Percentage of participants with a previous history of emetic episodes
After participants have completed their informed consent, they will complete a baseline assessment to record emetic episodes prior to chemotherapy.
Time frame: Baseline assessment
Percentage of participants with a complete response of no emetic episode
Patient will be monitored for vomiting on Day 1 after receiving chemotherapy. The participants will complete a vomiting assessment and record the number of episodes (none, once, more than once and number)
Time frame: Baseline through 24 hours
Percentage of participants with a complete response of no emetic episode
Patient will be monitored for vomiting on Day 2 through Day 6 after receiving chemotherapy. The participants will complete a vomiting assessment and record the number of episodes (none, once, more than once and number)
Time frame: Day 2 through Day 6
Percentage of participants with a complete response of no emetic episode
Patient will be monitored for total vomiting episodes starting from Day 1 through Day 6 after receiving chemotherapy. The participants will complete a vomiting assessment and record the number of episodes (none, once, more than once and number)
Time frame: Day 1 through Day 6
Percentage of participants frequency rate of No Nausea
Participants will complete a Visual Analogue Scale at baseline to record their history of the presence or absence of nausea and frequency prior to chemotherapy. The scale range is between 0 - 10 (0 = No Nausea; 10 = Excessive Nausea).
Time frame: Baseline
Percentage of participants frequency rate of No Nausea
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Participants will complete a Visual Analogue Scale on Day 1 to record the presence or absence of nausea and frequency after receiving chemotherapy. The scale range is between 0 - 10 (0 = No Nausea; 10 = Excessive Nausea).
Time frame: Baseline through 24 hours
Percentage of participants frequency rate of No Nausea
Participants will complete a Visual Analogue Scale on Day 2 through Day 6 to record the presence or absence of nausea and frequency after receiving chemotherapy. The scale range is between 0 - 10 (0 = No Nausea; 10 = Excessive Nausea).
Time frame: Day 2 through Day 6
Percentage of participants frequency rate of No Nausea
Participants will complete a Visual Analogue Scale on Day 1 through Day 6 to record the presence or absence of nausea and frequency after receiving chemotherapy. The scale range is between 0 - 10 (0 = No Nausea; 10 = Excessive Nausea).
Time frame: Day 1 through Day 6
Percentage of participants experiencing GERSC toxicity
The toxicity will be assessed by the severity of the side effects listed below. The descriptions and grading scales found in the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 will be utilized for reporting. * Constipation * Fatigue * Headache * Diarrhea * Abdominal Pain * Sleeplessness (Insomnia) * Indigestion (Dyspepsia) * Dizziness * Asthenia * Gastroesophageal Reflux
Time frame: Baseline through 30 days