Health Condition 1: K928- Other specified diseases of the digestive system
Conditions
Interventions
Intervention1: Amisulpride: amisulpride administered as oral capsules
25mg 30min before administration of chemotherapeutic agent
12.5mg to be takn daily for next 3 days before going to bed
Control In
Sponsors
Anand Srinivasan
Eligibility
Inclusion criteria
Inclusion criteria: 1. Cancer patients whose Eastern Cooperative Oncology Group (ECOG) performance status of between 0-2 (0-indicates no symptoms and 5- indicates increasing disability) who have been planned to receive a cancer chemotherapy regimen containing highly emetogenic cancer chemotherapeutic agents cisplatin >= 70 mg/m 2, or anthracycline cyclophosphamide (AC) regimen comprising cyclophosphamide (500â?? 1500 mg/m2) with either epirubicin (60â??100 mg/m2) or doxorubicin (40â??60 mg/m2), and who will be receiving the standard care premedication as 5HT3 antagonist (ondansetron 8mg or palonosetron 0.25mg ) + Inj.Dexamethasone 8mg. 2. Participants who gave written informed consent and had primary education qualifications. 3. Participants who can swallow the capsule.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in the occurence of nausea and vomiting after receiving chemotherapy assessed through telephonic follow up for 4 daysTimepoint: Outcome measured daily for 4 days at night before bedtime after starting the study medications | — |
Secondary
| Measure | Time frame |
|---|---|
| A comparative evaluation in the percentage of patients with no nausea in the acute (0 hrs to 24 hrs of post-chemotherapy) and delayed (24hrs to 4 days) period. 2. Comparative evaluation in the nausea rating in terms of VAS scores in acute, delayed and overall periods. 3. To determine the difference in the percentage of patients with complete response (no nausea/vomiting without any rescue medication) in the acute period (0 hrs to 24 hrs of post-chemotherapy) and delayed period (24hrs to 5 days). 4. A comparative evaluation in the percentage of patients with complete response in the overall period. 5. To measure the effectiveness of the intervention on improvement of patient quality of life using the FLIE questionnaire (39). 6. A comparative evaluation of the usage of rescue medication between both the groups. 7. To monitor the overall treatment-emergent adverse events and treatment specific adverse events such as undesired sedation, abnormal movements and others. Timepoint: 24hrs Day 1 Day 2 Day 3 Day 4 | — |
Countries
India
Contacts
Public ContactAnand Srinivasan
All India Institute of Medical Sciences
Outcome results
None listed