Hypersensitivity ReactionsPhase 3NCT03598426

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

A Phase 3 study testing Dexamethasone in people with Hypersensitivity Reactions, run by Loma Linda University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Hypersensitivity Reactions
What is being tested?: Dexamethasone
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 90 participants
Where: 1 siteUnited States
Study dates: 8 Aug 2018to 7 Jan 2025
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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:

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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:
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

Who cannot join

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

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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

Trial locations and contacts

1 site in 1 country.

United States1 site

Loma Linda University Cancer Center
Loma Linda, California, 92354

Other trials in United States

About this study

Official title: Conventional Prophylactic Regimen of Oral Dexamethasone Versus Short-course Intravenous Dexamethasone in Preventing Paclitaxel-related Hypersensitivity Reactions in Breast and Gynecologic Oncology Patients

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.

Read the detailed description

One of the potentially serious and dose-limiting toxicities of paclitaxel is the development of hypersensitivity reactions (HSRs). Up to 42% of patients receiving paclitaxel experience an HSR, with serious (> grade 3) reactions observed in about 2% of patients. Paclitaxel prescribing information and many other references therefore strongly recommend pre-medicating patients who are to be treated with paclitaxel-containing regimen with a corticosteroid, a histamine-1 (H1), and a histamine-2 (H2) antagonist prior to paclitaxel infusion. This is done to help prevent or minimize the occurrence of HSRs that could be caused by treating patients with paclitaxel. However, the method and timing of administering these pre-medications (particularly in the case of dexamethasone) have not been standardized. The current and most commonly used methods of preventing paclitaxel HSR includes one of the following: 1. Administering oral dexamethasone (20 mg), 12 hours and 6 hours prior to paclitaxel infusion and intravenous administration of H1 and H2 receptor antagonists 30 minutes prior to paclitaxel infusion (Conventional method); 2. Administering intravenous dexamethasone (20 mg), concurrently with H1 and H2 antagonists, 30 minutes prior to paclitaxel infusion (Short-course method); 3. Administering oral dexamethasone (20 mg), 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 goal of this study is to do a single center, prospective, randomized, open-label study to determine the most effective method in preventing paclitaxel HSR among these three commonly used methods.

Conditions: Hypersensitivity Reactions
Being tested: Dexamethasone
Medical subject headings: Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DexamethasoneDrug
Also called Decadron
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

Study groups in NCT03598426
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

Number Participants With Any-grade Paclitaxel-associated Hypersensitivity Reactions During the First Paclitaxel Infusion
The number of participants with any-grade paclitaxel-associated hypersensitivity reactions of the short-course group versus the conventional method group during the first paclitaxel infusion.
Measured: Change between start of the paclitaxel infusion and at least three hours post-infusion at the first paclitaxel treatment
Number of Participants With Grade 3 or Higher Paclitaxel-associated Hypersensitivity Reactions During the First Paclitaxel Infusion
The number of participants with grade 3 or higher paclitaxel-associated hypersensitivity reactions of the short-course group versus the conventional method group during the first paclitaxel infusion
Measured: Change between start of the paclitaxel infusion and at least three hours post-infusion at the first paclitaxel treatment

Secondary outcomes (1)

Number of Participants Who Discontinued Treatment During the First Paclitaxel Infusion
The number of participants who discontinued treatment due to paclitaxel-associated hypersensitivity reactions during the first paclitaxel infusion between the short-course group versus the conventional group.
Measured: Change between the first paclitaxel infusion and date of treatment discontinuation due to paclitaxel-associated hypersensitivity reactions

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Aug 20187 Jan 2025

First posted26 Jul 2018
Study start8 Aug 2018
Primary completion7 Jan 2025
Study completion7 Jan 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hypersensitivity ReactionsStudies of the same condition, open and under way.
More trials run by Loma Linda UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Single center, prospective, randomized, open-label study
Masking: None (open label)
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03598426
Sponsor's protocol ID: 5180198
Status last verified: Jun 2026
First submitted: 16 Jul 2018
Last updated: 9 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hypersensitivity Reactions trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Conventional Prophylactic Regimen of Oral Dexamethasone Versus Short-course Intravenous Dexamethasone in Preventing Paclitaxel-related Hypersensitivity Reactions in Breast and Gynecologic Oncology Patients
ClinicalTrials.gov ID: NCT03598426
Acronym / sponsor ID: 5180198
Conditions: Hypersensitivity Reactions
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: Loma Linda UniversityUniversity, hospital or other
Study start: 8 Aug 2018 (actual)
Primary completion: 7 Jan 2025 (actual)
Study completion: 7 Jan 2025 (actual)
First posted: 26 Jul 2018 (actual)
Results: Posted 9 Jun 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: Single center, prospective, randomized, open-label study

Arm	Type	Receives
Conventional	Active comparator	Drug: DexamethasoneOral 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.
Short-Course	Active comparator	Drug: DexamethasoneIntravenous 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.
Combined	Active comparator	Drug: DexamethasoneOral 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.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

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

Key exclusion criteria (15 listed)

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:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DexamethasoneAlso: DecadronConventional 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	Drug	Combined, Conventional, Short-Course

Primary outcome

Number Participants With Any-grade Paclitaxel-associated Hypersensitivity Reactions During the First Paclitaxel Infusion
Time frame: Change between start of the paclitaxel infusion and at least three hours post-infusion at the first paclitaxel treatment
The number of participants with any-grade paclitaxel-associated hypersensitivity reactions of the short-course group versus the conventional method group during the first paclitaxel infusion.
Number of Participants With Grade 3 or Higher Paclitaxel-associated Hypersensitivity Reactions During the First Paclitaxel Infusion
Time frame: Change between start of the paclitaxel infusion and at least three hours post-infusion at the first paclitaxel treatment
The number of participants with grade 3 or higher paclitaxel-associated hypersensitivity reactions of the short-course group versus the conventional method group during the first paclitaxel infusion

1 secondary outcome

Number of Participants Who Discontinued Treatment During the First Paclitaxel Infusion
Time frame: Change between the first paclitaxel infusion and date of treatment discontinuation due to paclitaxel-associated hypersensitivity reactions

Results and safety

Results posted to the registry on 9 Jun 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Conventional	30	29
Short-Course	27	25
Combined	33	32

Primary outcome: Number Participants With Any-grade Paclitaxel-associated Hypersensitivity Reactions During the First Paclitaxel Infusion

Time frame: Change between start of the paclitaxel infusion and at least three hours post-infusion at the first paclitaxel treatment. Number (95% Confidence Interval). Unit: participants

Measure	Conventional n = 29	Short-Course n = 25	Combined n = 32
Value	2 (0.902 to 18.501)	8 (1.084 to 19.865)	6 (0.716 to 14.059)

Primary outcome: Number of Participants With Grade 3 or Higher Paclitaxel-associated Hypersensitivity Reactions During the First Paclitaxel Infusion

Time frame: Change between start of the paclitaxel infusion and at least three hours post-infusion at the first paclitaxel treatment. Number. Unit: participants

Measure	Conventional n = 29	Short-Course n = 25	Combined n = 32
Value	0	0	1

1 secondary outcome is reported in the full results.

Adverse events

Time frame: At first administration period of Paclitaxel through the end of third administration period of Paclitaxel, an average of 9 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Conventional	0 of 29 (0%)	10 of 29 (34.5%)	0 of 29
Short-Course	0 of 25 (0%)	5 of 25 (20%)	0 of 25
Combined	1 of 32 (3.1%)	11 of 32 (34.4%)	0 of 32

Limitations and caveats (from the sponsor): Given our low accrural of our study over a longer study period than expected, our clinical trial was not published alone, but as a broader study including a systemic review and meta-analysis. Please refer to publication PMID: 40012138.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hypersensitivity Reactions

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Linda Hong, MD principal investigator

Loma Linda University Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dexamethasone in people with Hypersensitivity Reactions, run by Loma Linda University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number Participants With Any-grade Paclitaxel-associated Hypersensitivity Reactions During the First Paclitaxel Infusion (time frame: Change between start of the paclitaxel infusion and at least three hours post-infusion at the first paclitaxel treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03598426.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.