Conventional Prophylactic Oral Dexamethasone vs Short-course IV Dexamethasone in Paclitaxel Hypersensitivity

NCT03598426 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: 5180198
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single center, prospective, randomized, open-label study aimed at determining the most effective means of preventing hypersensitivity reactions in gynecologic oncology patients receiving paclitaxel infusions. The study will therefore provide clinicians with the best ways of preventing paclitaxel hypersensitivity reactions in their patients during treatment. Subjects will be randomized using the block randomization method into one of these three commonly used treatment methods:(1) Conventional method: oral dexamethasone (20 mg), taking 12 hours and 6 hours prior to paclitaxel infusion and intravenous administration of histamine-1 (H1), and a histamine-2 (H2)receptor antagonists administered 30 minutes prior to paclitaxel infusion. (2) Short-course method: intravenous dexamethasone (20 mg), administered concurrently with H1 and H2 antagonists, 30 minutes prior to paclitaxel infusion. (3) Combined method: oral dexamethasone (20 mg), taking 12 hours prior to treatment in addition to intravenous dexamethasone (20 mg), H1 and H2 receptor antagonists administered 30 minutes prior to paclitaxel infusion. The one-way analysis of variance (ANOVA) would be used to determine if there is any significant difference between the different strategies that are used to pre-medicate patients prior to paclitaxel infusion. P-values of less than 0.05 will be considered statistically significant.

Conditions

Hypersensitivity Reactions

Outcome Measures

Primary Outcomes (1)

• Least incidence of any-grade-paclitaxel-HSR first cycle

  The treatment group that had the least incidence of any-grade-paclitaxel-HSR in the first cycle of chemotherapy treatment

  1 to 3 HOURS

Secondary Outcomes (5)

• Least incidence of any-grade-paclitaxel-HSR in the first and second cycles

  1 to 3 HOURS

• Least incidence of grade 3 or more paclitaxel-HSR in the first and second cycles

  1 to 3 HOURS

• Least incidence of any-grade-paclitaxel-HSR second cycle

  1 to 3 HOURS

• Least incidence of grade 3 or more paclitaxel-HSR first cycle

  1 to 3 HOURS

• Least incidence of grade 3 or more paclitaxel-HSR second cycle

  1 to 3 HOURS

Study Arms (3)

Conventional

ACTIVE COMPARATOR

Oral dexamethasone (20 mg) at home, 12 hours and 6 hours prior to paclitaxel infusion. On the day of treatment at the clinic, an intravenous administration of diphenhydramine 50 mg and famotidine 20 mg, administered 30 minutes prior to paclitaxel infusion.

Drug: Dexamethasone

Short-Course

ACTIVE COMPARATOR

Intravenous administration of dexamethasone 20 mg, along with an intravenous administration of diphenhydramine 50 mg and famotidine 20 mg, administered 30 minutes prior to paclitaxel infusion.

Drug: Dexamethasone

Combined

ACTIVE COMPARATOR

Oral dexamethasone (20 mg) at home, 12 hours prior to paclitaxel infusion. On the day of treatment at the clinic, an additional intravenous administration of dexamethasone 20 mg, along with an intravenous administration of diphenhydramine 50 mg and famotidine 20 mg, administered 30 minutes prior to paclitaxel infusion.

Drug: Dexamethasone

Interventions

Dexamethasone DRUG

Conventional arm will only use oral dexamethasone as intervention; Short-Course arm will only use intravenous dexamethasone as intervention; Combined arm will use both oral and intravenous dexamethasone as intervention

Also known as: Decadron

Combined; Conventional; Short-Course

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female only
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult female patients \> 18 years of age
• Patients of the Loma Linda University Health (LLUH) gynecologic oncology and breast oncology service
• Confirmed breast or gynecologic cancer diagnosis of any stage and any gynecologic or breast malignancy
• Planned treatment with paclitaxel containing regimen either in the adjuvant setting or for palliation
• Planned treatment with paclitaxel should be for 3 or more cycles given as a weekly or every 3 weeks cycle
• Paclitaxel should be given as a monotherapy or as part of a combination regimen. If paclitaxel is part of a regimen containing other drugs, the following conditions must be met:
• Paclitaxel will be the first chemotherapy regimen to be infused when patient comes in for treatment
• Chemotherapy regimen that would be approved for the study are the following:
• i. Paclitaxel/ Carboplatin ii. Paclitaxel/Carboplatin/Bevacizumab iii. Paclitaxel/Cisplatin/Bevacizumab iv. Paclitaxel/Bevacizumab v. Paclitaxel/ Ifosfamide vi. Paclitaxel/ Pazopanib
• Patients should have no prior exposure to taxanes (this includes: paclitaxel, docetaxel, and protein-bound paclitaxel)
• The chemotherapy treatment should be at one of the LLUH Adult Cancer Centers
• The patient should be an English or Spanish speaking patient

You may not qualify if:

• Patients who are not with the gynecologic or breast oncology service
• Patients who are with the gynecologic oncology or breast oncology service but are not receiving paclitaxel either as a monotherapy or in combination with other regimen
• Patients who have had prior exposure to taxanes (this includes: paclitaxel, docetaxel, and protein-bound paclitaxel)
• Patients who are currently on steroid therapy and it is anticipated that therapy will not be discontinued at least a week prior to start of chemotherapy
• Patients with autoimmune diseases, malignancies, and any other co-morbid condition that might require steroid therapy during chemotherapy. This includes, but not limited to:
• Crohn's disease
• Immune thrombocytopenia
• Lupus nephritis
• Multiple sclerosis
• Primary brain tumors
• Multiple Myeloma
• Hodgkin's Lymphoma
• Patients with uncontrolled diabetes or diabetic or pre-diabetic patients with baseline A1C levels \> 8.5
• Patients who are allergic to diphenhydramine and/or dexamethasone
• Non-English and Non-Spanish speaking patients

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Cancer Center

Loma Linda, California, 92354, United States

Location

MeSH Terms

Conditions

Hypersensitivity

Interventions

Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Linda Hong, MD

  Loma Linda University Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Model Details: Single center, prospective, randomized, open-label study

Study Record Dates

• First Submitted: July 16, 2018
• First Posted: July 26, 2018
• Study Start: August 8, 2018
• Primary Completion: January 7, 2025
• Study Completion: January 7, 2025
• Last Updated: September 3, 2025

Record last verified: 2025-09

Locations

US (1)