Dexamethasone Regimens for Prophylaxis of Paclitaxel-associated Hypersensitivity Reaction

NCT02349763 | Completed Phase 3 DMC

• 1 other identifier: pHSR01
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

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

Hypersensitivity Reaction

Keywords

Dexamethasone; Hypersensitivity reaction; Paclitaxel

Outcome Measures

Primary Outcomes (1)

• Incidence of Paclitaxel-Associated Hypersensitivity Reaction (P-HSRs) and severe P-HSRs (Safety endpoint)

  The participants are received either intravenous dexamethasone or placebo (0.9% NaCL) at 09.30 am (30 minutes before paclitaxel infusion) depend on intervention groups. Intravenous ranitidine 50 mg and diphenhydramine 50 mg are also given all participants. Paclitaxel is started at 10.00 am by the calculated dose of is diluted in 500 ml of saline and administered by intravenous infusion over 3 hours.

  3 Hours after starting paclitaxel infusion

Secondary Outcomes (3)

• Incidence of side effects of dexamethasone

  1 week after completion of chemotherapy

• Incidence of other Adverse Events ( according to NCI CTCAE version 4.03)

  Adverse events were measured at Day 1 and Day 28 of intervention

• Quality of life (QoL) (assessed by FACT-O score)

  QoL is measured at Day 0 and Day 28 of intervention

Study Arms (2)

Oral Dexamethasone

ACTIVE COMPARATOR

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

Drug: Oral Dexamethasone

Intravenous Dexamethasone

EXPERIMENTAL

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

Drug: Intravenous Dexamethasone

Interventions

Intravenous Dexamethasone DRUG

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

Also known as: Dexazone

Intravenous Dexamethasone

Oral Dexamethasone DRUG

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

Also known as: Dexazone

Oral Dexamethasone

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Department of Medical Services Ministry of Public Health of Thailand: lead
• Chulalongkorn University: collaborator

Study Sites (1)

Rajavithi Hospital

Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Hypersensitivity

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Dr Marut Yanaranop, MD

  Department of Medical Services Ministry of Public Health of Thailand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2015
• First Posted: January 29, 2015
• Study Start: February 28, 2015
• Primary Completion: July 30, 2015
• Study Completion: August 30, 2015
• Last Updated: October 23, 2020

Record last verified: 2015-01

Locations

TH (1)