Dexamethasone Regimens for Prophylaxis of Paclitaxel-associated Hypersensitivity Reaction

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02349763
• Date of registration: 23/01/2015
• Prospective Registration: Yes
• Primary sponsor: Rajavithi Hospital
• Public title: Dexamethasone Regimens for Prophylaxis of Paclitaxel-associated Hypersensitivity Reaction DEPARO
• Scientific title: 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
• Date of first enrolment: February 28, 2015
• Target sample size: 260
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02349763
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Thailand

Contacts

• Name: Dr Marut Yanaranop, MD
• Affiliation: Rajavithi Hospital

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Hypersensitivity Reaction

Intervention(s)

Drug: Intravenous Dexamethasone

Drug: Oral Dexamethasone

Primary Outcome(s)

Incidence of Paclitaxel-Associated Hypersensitivity Reaction (P-HSRs) and severe P-HSRs (Safety endpoint) [Time Frame: 3 Hours after starting paclitaxel infusion]

Secondary Outcome(s)

Quality of life (QoL) (assessed by FACT-O score) [Time Frame: QoL is measured at Day 0 and Day 28 of intervention]

Incidence of other Adverse Events ( according to NCI CTCAE version 4.03) [Time Frame: Adverse events were measured at Day 1 and Day 28 of intervention]

Incidence of side effects of dexamethasone [Time Frame: 1 week after completion of chemotherapy]

Secondary ID(s)

pHSR01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Chulalongkorn University