The Efficacy of Premedication with 10 mg vs 20 mg of Intravenous Dexamethasone for Prevention of Paclitaxel Hypersensitivity Reaction in Gynecologic Cancer Patients: A Non-Inferiority, Randomized Controlled Trial

The Efficacy of Premedication with 10 mg vs 20 mg of Intravenous Dexamethasone for Prevent Paclitaxel Hypersensitivity reaction in Gynecologic Cancer patients: A Randomized Controlled Trial

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

TCTR

Registry ID

TCTR20201215005

Enrollment

122

Registered

2020-12-15

Start date

2021-04-09

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Long-term and frequent exposure to dexamethasone in gynecologic oncology patients who received paclitaxel can follow by steroid side effects. Paclitaxel, Hypersensitivity reaction, Dexamethasone, 10 mg

Interventions

For the next cycle, premedication with dexamethasone 20 mg after the first cycle (premedication with 20 mg) had no any hypersensitivity reaction.,For the next cycle, premedication with dexamethasone 1

Active Comparator Drug,Experimental Drug

Control group,Study group

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Aged 18 years of age or older 2) Planned to receive carboplatin and paclitaxel regimen (PT) for the first time 3) Normal bone marrow, renal, and liver function 4) No history of dexamethasone and/or paclitaxel allergy 5) No current medication with any steroidal drugs

Exclusion criteria

Exclusion criteria: 1. Cardiac diseases such as atrial or ventricular arrhythmia, congestive heart failure, heart block 2. History of myocardial infarction within 6 months 3. Active pulmonary disease

Design outcomes

Primary

Measure	Time frame
Rate of hypersensitivity reaction at time of investigation Hypersensitivity Reactions Grading (common toxicity criteria version 5.0)	—

Secondary

Measure	Time frame
Nausea and vomiting within 1-2 week after receive chemotherapy Common toxicity criteria version 5.0	—

Countries

Thailand

Contacts

Public ContactNutthakarn Sangiamphorn

Faculty of Medicine, Chiang Mai University

nukkynikky.g@gmail.com0643322345

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026