Health Condition 1: R110- Nausea
Conditions
Interventions
Intervention1: Add on Olanzapine 5mg plus Pregabalin 75mg: capsules Olanzapine contains 5mg olanzapine and capsules of Pregabalin contains 75mg pregabalin
dose- 1 capsule of each drug will be given
Sponsors
Dr 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 cancer chemotherapy regimen containing moderately to highly emetogenic cancer chemotherapeutic agents. 2. Patients who gave written informed consent and who can swallow the capsule.
Exclusion criteria
Exclusion criteria: 1.History of Nausea or Vomiting within 24 hours before enrolment. 2.Elevated lab parameters such as serum creatinine level of more than 2.0 mg per decilitre, aspartate or alanine aminotransferase level greater than 3 times of normal upper limit, and absolute neutrophil count were less than 1500 per mm3. 3.Patients with either primary or secondary central nervous system malignancy. 4.Patients who are on treatment with either pregabalin or another antipsychotic agent within 30 days of enrolment or planned to receive them during the study period. 5.Patient with known History of hypersensitivity to olanzapine or pregabalin. 6.Patients with known History of uncontrolled congestive heart failure, cardiac arrhythmia, or acute myocardial infarction events within the previous six months. 7.Patient with uncontrolled diabetes mellitus. 8.Patients with condition causing upper gastrointestinal tract obstruction as per radiological findings. 9.Patients with metabolic disorders. 10.Pregnant and lactating women. 11.Patient with a history of central nervous system disease such as seizure disorder, Parkinson disease, psychiatric illness, and severe cognitive compromise.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the efficacy of the add-on combination of olanzapine and pregabalin as the difference in the percentage of patients with no nausea between the groups over 5 days from the day of administration of cancer chemotherapy.Timepoint: 5 days | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the difference in nausea rating in terms of VAS scores in acute, delayed and overall periods.Timepoint: 5 days;To monitor the overall treatment-emergent adverse events and treatment specific adverse events such as undesired sedation, appetite, and difficulty in vision.Timepoint: 5days;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), delayed (24hrs to 5 days) period and over all periodTimepoint: 5 days;To determine the difference in the percentage of patients with no nausea in the acute (0 hrs to 24 hrs of post-chemotherapy) period, delayed (24hrs to 5 days) period.Timepoint: 5 days;To determine the difference in the percentage of patients with no significant nausea (VAS â?¤ 25mm) in acute (0 hrs to 24 hrs of post-chemotherapy) period, delayed (24hrs to 5 days) period and over all periodTimepoint: 5 days;To determine the difference in the usage of rescue medication between both the groupsTimepoint: 5 days;To measure the effectiveness of the intervention on improvement of patient quality of life using the FLIE questionnaire.Timepoint: 5 days | — |
Countries
India
Contacts
Public ContactDr Mathan Kumar
All India Institute of Medical Sciences
Outcome results
None listed