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Dexamethasone Regimens for Prophylaxis of Paclitaxel-associated Hypersensitivity Reaction (DEPARO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02349763
Recruitment Status : Unknown
Verified January 2015 by Kanya Boonthongtho, Rajavithi Hospital.
Recruitment status was:  Not yet recruiting
First Posted : January 29, 2015
Last Update Posted : January 29, 2015
Sponsor:
Collaborator:
Chulalongkorn University
Information provided by (Responsible Party):
Kanya Boonthongtho, Rajavithi Hospital

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.

Condition or disease Intervention/treatment Phase
Hypersensitivity Reaction Drug: Intravenous Dexamethasone Drug: Oral Dexamethasone Phase 3

Detailed Description:

The consensus statements on the management of ovarian cancer recommended intravenous paclitaxel (175 mg/m2 over 3 hr) plus intravenous carboplatin (area under the curve [AUC] 5.0-7.5 mg/ml∙min) given every 3 weeks for six cycles for first-line chemotherapy. A major limitation of paclitaxel was its poor water solubility, which led to the use of polyoxyethylated castor oil vehicle or Cremophor® EL as diluents resulted a hypersensitivity reactions (HSRs). Initial P-HSRs generally occur within 10 minutes of the start of paclitaxel infusion and most occur with the first or second infusion. Majority of patients manifest as minor symptoms characterized by flushing and rashes but sometime life-threatening characterized by generalized urticaria, angioedema, bronchospasm and hypertension or until fatal may occur. The reaction is likely due to the release of histamine and other vasoactive substances in response to Cremophor EL. Originally, the prophylactic regimen composed of the use of an oral corticosteroid administered in two doses at 12 and 6 hours prior to paclitaxel infusion accompanied with histamine receptor H1 and H2 antagonists administered intravenously 30 minutes prior to paclitaxel infusion was found to successfully limit P-HSRs denoted as "Conventional oral prophylactic regimen".

While this three-drug prophylactic regimen has been shown to be effective, it can be inconvenient for patients because the oral corticosteroid must be taken 12 and 6 hours before chemotherapy administration. If the patient forgets to take one or both pretreatment steroid doses, it is not clear whether the patient can be safely treated. This led to the experimental prophylactic regimen of one dose of intravenous dexamethasone accompanied with the H1 and H2 antagonists administered 30 minutes prior to paclitaxel infusion was subsequently reported to be equivalent to the regimen of oral dexamethasone denoted as "Modified intravenous prophylactic regimen". This intravenous regimen results in lower total steroid doses and precludes the issues of compliance.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official 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
Study Start Date : February 2015
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Active Comparator: Oral Dexamethasone
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
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
Other Name: Dexazone

Experimental: Intravenous Dexamethasone
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
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
Other Name: Dexazone




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


Secondary Outcome Measures :
  1. Incidence of side effects of dexamethasone [ Time Frame: 1 week after completion of chemotherapy ]
    All participants receive the personal logbook for self-administration of side effects from dexamethasone in day 1-7

  2. 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 ]
    The adverse events are collected according to NCI CTCAE version 4.03.

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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02349763


Contacts
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Contact: Dr Marut Yanaranop, MD 66813450015 myanaran@hotmail.com
Contact: Kanya Boonthongtho, MD 6623548108 ext 2803 kanyanana@yahoo.com

Locations
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Thailand
Rajavithi Hospital
Bangkok, Thailand, 10400
Sponsors and Collaborators
Rajavithi Hospital
Chulalongkorn University
Investigators
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Principal Investigator: Dr Marut Yanaranop, MD Rajavithi Hospital

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Responsible Party: Kanya Boonthongtho, Dr Marut Yanaranop, Rajavithi Hospital
ClinicalTrials.gov Identifier: NCT02349763    
Other Study ID Numbers: pHSR01
First Posted: January 29, 2015    Key Record Dates
Last Update Posted: January 29, 2015
Last Verified: January 2015
Keywords provided by Kanya Boonthongtho, Rajavithi Hospital:
Dexamethasone
Hypersensitivity reaction
Paclitaxel
Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases
Dexamethasone
Dexamethasone acetate
Paclitaxel
Albumin-Bound Paclitaxel
BB 1101
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Protease Inhibitors
Enzyme Inhibitors