Evaluation of effectiveness of Dex-sparing benefits of Netupitant and palonosetron in Cancer patients

Not Applicable

Conditions: Health Condition 1: R112- Nausea with vomiting, unspecified

Registration Number: CTRI/2021/01/030563

Lead Sponsor: Prince Aly Khan Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Chemotherapy-naive patients.

2. Adult male and female subjects aged >=18 years

3. Scheduled to receive HEC regimen.

4. Eastern Cooperative Oncology Group (ECOG) performance status 0â??1

5. Adequate general condition (white blood cell count 3Ã?109 cells/ L), hepatic function (aspartate aminotransferase [AST] and alanine aminotransferase [ALT]

6. Willing to provide written informed consent.

Exclusion Criteria

1. Seizure disorder needing anticonvulsants, unless clinically stable;

2. Any Prior vomiting, retching, or grade 2 or higher nausea according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE);

3. Asymptomatic metastases to the brain

4. Known hypersensitivity to palonosetron, Netupitant or dexamethasone excipients

5.Pregnant/breast-feeding women

6. Those receiving any drug with antiemetic effects

7. Those who were unable to cooperate or judged by an investigator to be unfit for participation in the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complete response (CR) from chemotherapy administration. (CR is defined as no emetic episode and no use of rescue medication)Timepoint: 0-120 hours

Secondary Outcome Measures

Name	Time	Method
1. CR during acute (0-24 hours) and delayed (24-120 hours) phases, Complete control (CC) during the overall phase and safety of these antiemetic therapies (CC is defined as CR and no significant nausea ( VAS 2.5mm)) <br/ ><br>2. Time to failure (i.e., time to first emetic episode or time to rescue) may be interesting secondary end-points <br/ ><br>3. Evaluation as per MASCC (Mutinational Association of Supportive care in cancer) Chemotherapy Induce nausea Vomiting (CINV) Risk Score <br/ ><br>Timepoint: 1. 0-24 hours, 24-120 hours,VAS 2.5mm