Health Condition 1: C509- Malignant neoplasm of breast of unspecified site Health Condition 2: C539- Malignant neoplasm of cervix uteri, unspecified Health Condition 3: C399- Malignant neoplasm of lower respiratory tract, part unspecified Health Condition 4: C140- Malignant neoplasm of pharynx, unspecified
Conditions
Interventions
Intervention1: Pregabalin: add-on pregabalin (75 mg )per day for 4 days
Intervention2: olanzapine: Add-on olanzapine (5 mg/day) for 4 days
Control Intervention1: starched filled placebo capsules: star
Sponsors
All India Institute of Medical sciences bhubaneswar
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 highly emetogenic cancer chemotherapeutic agents (cisplatin or Adriamycin plus cyclophosphamide) and will be receiving the standard care premedication as Inj.Ondansetron 8mg + 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: 1. H/O 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 three times of normal upper limit, and absolute neutrophil count were less than 1500/mm3. 3. Patients with either primary or secondary CNS malignancy. 4. Patients with a h/o central nervous system (CNS) disease such as seizure disorder, Parkinson disease, psychiatric illness, and severe cognitive compromise. 5. Patients who are on treatment with either Gabapentinoids or another antipsychotic agent within 30 days of enrolment or planned to receive them during the study period. 6. Patient with known H/O hypersensitivity to olanzapine or pregabalin. 7. Patients who are planned to receive concurrent radiotherapy coinciding with the current chemotherapy cycles. 8. Patients with known H/O uncontrolled congestive heart failure, cardiac arrhythmia, or acute myocardial infarction events within the previous six months. 9. Patient with diabetes mellitus. 10. Patients with a condition causing upper gastrointestinal tract obstruction as per radiological findings. 11. Patients with metabolic disorders (such as hypercalcemia, hyperglycaemia or hyponatremia, uraemia causing nausea and vomiting. 12. Pregnant and lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the interaction effect of add-on pregabalin (75 mg) and olanzapine (5 mg) in the prevention of CINV in terms of VAS score of nausea in the study groups over five days (cumulative score), from the day of administration of highly emetogenic cancer chemotherapy.Timepoint: 5 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 10. To determine the difference in the usage of rescue medication between both groups.Timepoint: 5 days;11. To monitor the overall treatment-emergent adverse events and treatment specific adverse events such as undesired sedation, appetite, and difficulty in visionTimepoint: 5 days;8. To determine the difference in the percentage of patients with complete response in the overall periodTimepoint: 5 days;9. To measure the effectiveness of the intervention on improvement of patient Quality of life using the FLIE questionnaireTimepoint: 5 days;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).Timepoint: 5 days;To determine the difference in the percentage of patients with complete response in the delayed period (24hrs to 5 days).Timepoint: 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.Timepoint: 5 days;To determine the difference in the percentage of patients with no nausea in the in delayed (24hrs to 5 days) periodTimepoint: 5 days;To determine the difference in the percentage of patients with no nausea in the overall (0hrs to 5 days) periodTimepoint: 5 days;To determine the interaction effect of add-on pregabalin (75 mg) and olanzapine (5 mg) in the prevention of CINV in terms of VAS score of nausea in the study groups over five days (individual day score), from the day of administration of highly emetogenic cancer chemotherapy.Timepoint: 5 days | — |
Countries
India
Contacts
Public ContactAnand Srinivasan
AIIMS BHUBANESHWAR
Outcome results
None listed