A factorial 2 by 2 randomized double-blinded clinical trial to evaluate the interaction between pregabalin and olanzapine for the prevention of chemotherapy-induced nausea and vomiting in patients receiving highly emetogenic chemotherapeutic regimen in a day care setting

Phase 4

• Conditions: Health Condition 1: C509- Malignant neoplasm of breast of unspecified siteHealth Condition 2: C539- Malignant neoplasm of cervix uteri, unspecifiedHealth Condition 3: C399- Malignant neoplasm of lower respiratory tract, part unspecifiedHealth Condition 4: C140- Malignant neoplasm of pharynx, unspecified

• Registration Number: CTRI/2022/02/040629
• Lead Sponsor: All India Institute of Medical sciences bhubaneswar

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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