A Phase 3 interventional study of Intravenous Dexamethasone and Oral Dexamethasone in Hypersensitivity Reaction, sponsored by Rajavithi Hospital. Completed at 1 site in Thailand. Open to female participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-23.
Sponsored by Rajavithi Hospital · Phase 3, Interventional, and Prevention
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.
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.
1,916 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.
This study's enrollment of 260 is above the median of 57 across 1,384 interventional studies indexed under Hypersensitivity.
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Exclusion Criteria:
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
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
Also known as: Dexazone
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
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.
Time frame: 3 Hours after starting paclitaxel infusion
Incidence of side effects of dexamethasone
All participants receive the personal logbook for self-administration of side effects from dexamethasone in day 1-7
Time frame: 1 week after completion of chemotherapy
Incidence of other Adverse Events ( according to NCI CTCAE version 4.03)
The adverse events are collected according to NCI CTCAE version 4.03.
Time frame: Adverse events were measured at Day 1 and Day 28 of intervention
Quality of life (QoL) (assessed by FACT-O score)
Quality of life assessed by FACT-O score
Time frame: QoL is measured at Day 0 and Day 28 of intervention
This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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Rajavithi Hospital