preventing chemotherapy induced nausea and vomiting without using steroid (dexamethasone)

Phase 3

Completed

• Conditions: Health Condition 1: C00-D49- Neoplasms

• Registration Number: CTRI/2022/03/040906
• Lead Sponsor: Cancer Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-01-17
• Last Update Posted: 6 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 350

Inclusion Criteria

1. Age between 18 to 80 years and diagnosed with cancer.

2. Chemotherapy naïve.

3. Receiving single day Highly Emetogenic Chemotherapy.

4. Absence of nausea or vomiting 24 hours before enrollment.

5. Eastern Cooperative Oncology Group performance status of 0, 1, or 2.

6. Adequate organ function as confirmed by laboratory investigations within 2 weeks

[Aspartate transaminase (AST) and Alanine transaminase (ALT) within 5 times the

upper limit of normal (ULN), serum bilirubin less than 2 mg/dL, serum creatinine

within ULN].

7. Hb more than 7 gms%, WBC more than 4000/cumm and platelets more than 100,000/cumm.

8. No concurrent use of quinolone antibiotic therapy.

9. No severe alcohol use disorder as defined by Diagnostic Statistical Manual of Mental

Disorders, 5th Edition (DSM-5).

10. Women enrolled in the trial need to have a negative pregnancy test within seven days

of enrollment and continue to practice contraception during the study period. 

11. Written informed consent before enrollment.

Exclusion Criteria

1.Pediatric patients (age less than 18 years)

2.Patients receiving steroids as part of the chemotherapy regimen or needed as pre-medication for the prevention of allergic reactions. For eg: paclitaxel and carboplatin.

3.Patients receiving multi-day chemotherapy in a chemotherapy block.

4.Patients with brain metastasis.

5.No abdominal radiotherapy.

6.Patients in whom there are contraindications for corticosteroid use like uncontrolled diabetes mellitus, uncontrolled hypertension, and active peptic ulcer disease.

7.History of allergy to any of the drugs used for anti-emetic prophylaxis.

8.Treatment with another antipsychotic agent such as risperidone, quetiapine, clozapine, phenothiazine, or butyrophenone for 30 days before or during the protocol therapy.

9.Known cardiac arrhythmia, uncontrolled congestive heart failure, or acute myocardial infarction within the previous six months.

10.History of neurological disorders including seizures and stroke within the last 6 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified