H2 blocker free chemotherapy

Phase 3

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

• Registration Number: CTRI/2021/11/038139
• Lead Sponsor: CI AIIMS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 February 2022

Recruitment & Eligibility

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

Inclusion Criteria

Adults patients with age between 18 years to 70 years

Histopathological diagnosis of cancer

Willing to participate and to give written informed consent

Planned to receive conventional paclitaxel chemotherapy either as single agent or in combination

Paclitaxel naive

No known hypersensitivity to partner chemotherapy drug

ECOG performance status 0-2

Stable baseline vital signs: Afebrile, radial artery blood pressure (90/60 â?? 130/90mm Hg), pulse rate 60 â?? 100 / minutes, respiratory rate 12-18/ minutes, 97.8 °F to 99.1 °F (36.5° C to 37.3° C)

Exclusion Criteria

Past history of hypersensitivity reaction to paclitaxel or cremophor containing drugs (cyclosporine, propofol, diazepam, teniposide, etoposide, Vitamin K) or partner drug or pheniramine or ranitidine

On chronic systemic steroids or received any dose in the last week

No history of hypersensitivity to partner drug

Hb < 8gm/dl, ANC < 1000/m3, creatinine > 2mg/dl, Bilirubin > 5 X ULN, transaminases 10 times or more

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the incidence of all grade paclitaxel infusion related acute hypersensitivity reaction without H2 antagonist administrationTimepoint: 4 - 5 hours

Secondary Outcome Measures

Name	Time	Method
To determine the incidence of severe grade (3 or more) paclitaxel infusion related acute hypersensitivity reaction without H2 antagonist administration <br/ ><br>To determine the risk factor associated with paclitaxel infusion related acute hypersensitivity reaction <br/ ><br>To determine the incidence and time to paclitaxel infusion related acute hypersensitivity reaction in the different paclitaxel dose schedule (50 â?? 80mg/m2, 175mg/m2) <br/ ><br>Timepoint: 4-5 hours