Track topics on Twitter Track topics that are important to you
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
Chemotherapy-induced Nausea and Vomiting
GRANISETRON EXTENDED RELEASE INJECTION (GERSC)
The University of Alabama at Birmingham
Not yet recruiting
University of Alabama at Birmingham
Published on BioPortfolio: 2019-09-17T02:47:45-0400
The purpose of this study is to determine the dosing strategy for adolescents aged 13 to 17 years.
To compare palonosetron with granisetron hydrochloride as a control in the efficacy of intravenous single dose in preventing acute and delayed gastro-intestinal disorders, such as nausea a...
This study evaluates the effect of combining non pharmacological anti emetic prophylaxis, namely peppermint essential oil to granisetron and dexamethasone in patient who receive intratheca...
RATIONALE: Antiemetic drugs such as granisetron may help to prevent nausea and vomiting in patients treated with chemotherapy. PURPOSE: Randomized phase III trial to compare the effective...
The purpose of this trial is to determinate the security, tolerability and efficacy of aprepitant plus palonosetron versus granisetron in the prevention of nausea and emesis induced by che...
The aim of this study was to analyze the potential impact of chemotherapy-induced nausea and vomiting (CINV) on dose reductions, discontinuation of chemotherapy, and survival.
The purpose of the study was to compare efficacy and toxicity of olanzapine (OLN; a higher-cost drug) and haloperidol (HAL; a lower-cost drug) in the prevention of chemotherapy-induced nausea and vomi...
This study will be proposed for assessing the effects of electrical stimulation (ES) for chemotherapy-induced nausea and vomiting (CINV) in patients with liver cancer (LC).
Research by our group has shown that acupressure bands are efficacious in reducing chemotherapy-induced nausea (CIN) for breast cancer patients who expect nausea, and that their effectiveness in contr...
Little evidence exists regarding the emetogenicity of chemotherapy in pediatric patients. This study describes the prevalence of chemotherapy-induced nausea and vomiting (CINV) in pediatric patients r...
A serotonin receptor (5HT-3 selective) antagonist that has been used as an antiemetic for cancer chemotherapy patients.
A drug combination that contains DIPHENHYDRAMINE and THEOPHYLLINE. It is used for treating vertigo, motion sickness, and nausea associated with pregnancy. It is not effective in the treatment of nausea associated with cancer chemotherapy.
FEVER accompanied by a significant reduction in NEUTROPHIL count associated with CHEMOTHERAPY.
Drug treatment designed to further diminish the disease toward complete remission following INDUCTION CHEMOTHERAPY. It helps to consolidate the gains during induction chemotherapy and may be followed by MAINTENANCE CHEMOTHERAPY.
Treatment designed to help prevent a relapse of a disease following the successful primary treatments (INDUCTION CHEMOTHERAPY and CONSOLIDATION CHEMOTHERAPY) with a long-term low-dose drug therapy.