Clinical trial · Interventional
Dexamethasone Regimens for Prophylaxis of Paclitaxel-associated Hypersensitivity Reaction
Intravenous Versus Oral Regimens of Dexamethasone for Prophylaxis of Paclitaxel-associated Hypersensitivity Reaction in Primary Ovarian, Fallopian Tube and Peritoneal Cancer Patients: a Double-blind Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Comparison of the efficacy and side effects of intravenous and oral regimens of dexamethasone for prophylaxis of paclitaxel-associated hypersensitivity reactions in primary ovarian, fallopian tube and peritoneal cancer patients receiving first cycle of combination paclitaxel and carboplatin.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hypersensitivity Reaction | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intravenous Dexamethasone | Drug | Dexamethasone | ALIAS |
| Oral Dexamethasone | Drug | Dexamethasone | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Oral Dexamethasone
- description
- Dexamethasone 20 mg (4 mg/tablet) or 5 tablets given orally at 12 and 6 hours before paclitaxel infusion and 0.9% NaCL (Placebo) 4 ml given intravenously at 30 minutes before paclitaxel infusion
- interventionNames
- Drug: Oral Dexamethasone
- type
- EXPERIMENTAL
- label
- Intravenous Dexamethasone
- description
- Lactose (Placebo) 5 tablets given orally at 12 and 6 hours before paclitaxel infusion and dexamethasone 20 mg (5mg/ml) given intravenously at 30 minutes before paclitaxel infusion
- interventionNames
- Drug: Intravenous Dexamethasone
Primary outcomes (1)
- measure
- Incidence of Paclitaxel-Associated Hypersensitivity Reaction (P-HSRs) and severe P-HSRs (Safety endpoint)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patient pathologically diagnosed with primary ovarian or fallopian tube or peritoneal cancer * Patient starting a first cycle of combination paclitaxel and carboplatin at Rajavithi Hospital between February 1, 2015 and July 31, 2015 * Patient aged 18-70 years * Patient with ECOG performance status 0-2 * Patient with the following laboratory values obtained: Hemoglobin \> 10 g/dL, Absolute neutrophil count \> 1500 /mm3, Platelet count \> 100,000/mm3, Serum creatinine \> 2.0 mg/dL, Bilirubin \> 1.5 x ULN, alkaline phosphatase and SGOT \> 3 x ULN * Patient able to give free and informed consent and who agrees to participate by signing the consent form * Patient able to speak and understand Thai * Patient able to complete the quality of life questionnaire on Functional Assessment of Cancer Therapy - Ovarian Cancer (FACT-O) Thai version 4.0 and the personal logbook Exclusion Criteria: * Patient who has previously received paclitaxel or carboplatin * Patient receiving an albumin-bound paclitaxel * Patient who had an allergic reaction to taxanes or platinum analogues * Patient is currently under treatment with systemic corticosteroids or has received systemic corticosteroids or histamine antagonists during the last week * Patient who had an allergic reaction to corticosteroid or diphenhydramine or ranitidine * Patient with severe intolerance to lactose * Patient with an allergy or a severe intolerance to products containing castor oil e.g. cyclosporine, teniposide, diazepam, propofol
References
Publications (0)
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