Trial Outcomes & Findings for Conventional Prophylactic Oral Dexamethasone vs Short-course IV Dexamethasone in Paclitaxel Hypersensitivity (NCT NCT03598426)
NCT ID: NCT03598426
Last Updated: 2026-06-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
90 participants
Primary outcome timeframe
Change between start of the paclitaxel infusion and at least three hours post-infusion at the first paclitaxel treatment
Results posted on
2026-06-09
Participant Flow
Participant milestones
| Measure |
Conventional
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.
Dexamethasone: 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
|
Short-Course
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.
Dexamethasone: 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
|
Combined
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.
Dexamethasone: 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
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
27
|
33
|
|
Overall Study
COMPLETED
|
29
|
25
|
32
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
1
|
Reasons for withdrawal
| Measure |
Conventional
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.
Dexamethasone: 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
|
Short-Course
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.
Dexamethasone: 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
|
Combined
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.
Dexamethasone: 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
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
2
|
1
|
Baseline Characteristics
Conventional Prophylactic Oral Dexamethasone vs Short-course IV Dexamethasone in Paclitaxel Hypersensitivity
Baseline characteristics by cohort
| Measure |
Conventional
n=29 Participants
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.
Dexamethasone: 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
|
Short-Course
n=25 Participants
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.
Dexamethasone: 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
|
Combined
n=32 Participants
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.
Dexamethasone: 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
|
Total
n=86 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58 Years
n=20 Participants
|
62 Years
n=20 Participants
|
59.5 Years
n=40 Participants
|
60 Years
n=6 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=20 Participants
|
25 Participants
n=20 Participants
|
32 Participants
n=40 Participants
|
86 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
3 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
8 Participants
n=40 Participants
|
11 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
5 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
12 Participants
n=20 Participants
|
9 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
28 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
White or Caucasion
|
13 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
13 Participants
n=40 Participants
|
37 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Other or Unknown
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
2 Participants
n=6 Participants
|
|
Region of Enrollment
United States
|
29 Participants
n=20 Participants
|
25 Participants
n=20 Participants
|
32 Participants
n=40 Participants
|
86 Participants
n=6 Participants
|
|
Body Mass Index
|
26.53 k/m^2
n=20 Participants
|
30.63 k/m^2
n=20 Participants
|
30.80 k/m^2
n=40 Participants
|
28.45 k/m^2
n=6 Participants
|
PRIMARY outcome
Timeframe: Change between start of the paclitaxel infusion and at least three hours post-infusion at the first paclitaxel treatmentThe 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.
Outcome measures
| Measure |
Conventional
n=29 Participants
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.
Dexamethasone: 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
|
Short-Course
n=25 Participants
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.
Dexamethasone: 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
|
Combined
n=32 Participants
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.
Dexamethasone: 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
|
|---|---|---|---|
|
Number Participants With Any-grade Paclitaxel-associated Hypersensitivity Reactions During the First Paclitaxel Infusion
|
2 participants
Interval 0.902 to 18.501
|
8 participants
Interval 1.084 to 19.865
|
6 participants
Interval 0.716 to 14.059
|
PRIMARY outcome
Timeframe: Change between start of the paclitaxel infusion and at least three hours post-infusion at the first paclitaxel treatmentThe 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
Outcome measures
| Measure |
Conventional
n=29 Participants
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.
Dexamethasone: 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
|
Short-Course
n=25 Participants
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.
Dexamethasone: 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
|
Combined
n=32 Participants
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.
Dexamethasone: 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
|
|---|---|---|---|
|
Number of Participants With Grade 3 or Higher Paclitaxel-associated Hypersensitivity Reactions During the First Paclitaxel Infusion
|
0 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Change between the first paclitaxel infusion and date of treatment discontinuation due to paclitaxel-associated hypersensitivity reactionsThe 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.
Outcome measures
| Measure |
Conventional
n=29 Participants
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.
Dexamethasone: 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
|
Short-Course
n=25 Participants
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.
Dexamethasone: 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
|
Combined
n=32 Participants
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.
Dexamethasone: 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
|
|---|---|---|---|
|
Number of Participants Who Discontinued Treatment During the First Paclitaxel Infusion
|
0 participants
|
0 participants
|
1 participants
|
Adverse Events
Conventional
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Short-Course
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Combined
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Conventional
n=29 participants at risk
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.
Dexamethasone: 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
|
Short-Course
n=25 participants at risk
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.
Dexamethasone: 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
|
Combined
n=32 participants at risk
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.
Dexamethasone: 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
|
|---|---|---|---|
|
General disorders
Grade 3 dexamethasone related hypersensitivity reaction
|
0.00%
0/29 • At first administration period of Paclitaxel through the end of third administration period of Paclitaxel, an average of 9 weeks.
|
0.00%
0/25 • At first administration period of Paclitaxel through the end of third administration period of Paclitaxel, an average of 9 weeks.
|
3.1%
1/32 • At first administration period of Paclitaxel through the end of third administration period of Paclitaxel, an average of 9 weeks.
|
Other adverse events
| Measure |
Conventional
n=29 participants at risk
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.
Dexamethasone: 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
|
Short-Course
n=25 participants at risk
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.
Dexamethasone: 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
|
Combined
n=32 participants at risk
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.
Dexamethasone: 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
|
|---|---|---|---|
|
Gastrointestinal disorders
GERD
|
3.4%
1/29 • At first administration period of Paclitaxel through the end of third administration period of Paclitaxel, an average of 9 weeks.
|
0.00%
0/25 • At first administration period of Paclitaxel through the end of third administration period of Paclitaxel, an average of 9 weeks.
|
0.00%
0/32 • At first administration period of Paclitaxel through the end of third administration period of Paclitaxel, an average of 9 weeks.
|
|
Cardiac disorders
Hypertension
|
3.4%
1/29 • At first administration period of Paclitaxel through the end of third administration period of Paclitaxel, an average of 9 weeks.
|
4.0%
1/25 • At first administration period of Paclitaxel through the end of third administration period of Paclitaxel, an average of 9 weeks.
|
12.5%
4/32 • At first administration period of Paclitaxel through the end of third administration period of Paclitaxel, an average of 9 weeks.
|
|
Nervous system disorders
Anxiety
|
3.4%
1/29 • At first administration period of Paclitaxel through the end of third administration period of Paclitaxel, an average of 9 weeks.
|
0.00%
0/25 • At first administration period of Paclitaxel through the end of third administration period of Paclitaxel, an average of 9 weeks.
|
0.00%
0/32 • At first administration period of Paclitaxel through the end of third administration period of Paclitaxel, an average of 9 weeks.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/29 • At first administration period of Paclitaxel through the end of third administration period of Paclitaxel, an average of 9 weeks.
|
4.0%
1/25 • At first administration period of Paclitaxel through the end of third administration period of Paclitaxel, an average of 9 weeks.
|
0.00%
0/32 • At first administration period of Paclitaxel through the end of third administration period of Paclitaxel, an average of 9 weeks.
|
|
Nervous system disorders
Hyperactivity
|
0.00%
0/29 • At first administration period of Paclitaxel through the end of third administration period of Paclitaxel, an average of 9 weeks.
|
0.00%
0/25 • At first administration period of Paclitaxel through the end of third administration period of Paclitaxel, an average of 9 weeks.
|
3.1%
1/32 • At first administration period of Paclitaxel through the end of third administration period of Paclitaxel, an average of 9 weeks.
|
|
Endocrine disorders
Hyperglycemia
|
3.4%
1/29 • At first administration period of Paclitaxel through the end of third administration period of Paclitaxel, an average of 9 weeks.
|
0.00%
0/25 • At first administration period of Paclitaxel through the end of third administration period of Paclitaxel, an average of 9 weeks.
|
6.2%
2/32 • At first administration period of Paclitaxel through the end of third administration period of Paclitaxel, an average of 9 weeks.
|
|
Immune system disorders
Grade 1-2 dexamethasone related hypersensitivity reactions
|
0.00%
0/29 • At first administration period of Paclitaxel through the end of third administration period of Paclitaxel, an average of 9 weeks.
|
4.0%
1/25 • At first administration period of Paclitaxel through the end of third administration period of Paclitaxel, an average of 9 weeks.
|
0.00%
0/32 • At first administration period of Paclitaxel through the end of third administration period of Paclitaxel, an average of 9 weeks.
|
|
Nervous system disorders
Insomnia
|
3.4%
1/29 • At first administration period of Paclitaxel through the end of third administration period of Paclitaxel, an average of 9 weeks.
|
8.0%
2/25 • At first administration period of Paclitaxel through the end of third administration period of Paclitaxel, an average of 9 weeks.
|
6.2%
2/32 • At first administration period of Paclitaxel through the end of third administration period of Paclitaxel, an average of 9 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.4%
1/29 • At first administration period of Paclitaxel through the end of third administration period of Paclitaxel, an average of 9 weeks.
|
0.00%
0/25 • At first administration period of Paclitaxel through the end of third administration period of Paclitaxel, an average of 9 weeks.
|
0.00%
0/32 • At first administration period of Paclitaxel through the end of third administration period of Paclitaxel, an average of 9 weeks.
|
|
Nervous system disorders
Restlessness
|
6.9%
2/29 • At first administration period of Paclitaxel through the end of third administration period of Paclitaxel, an average of 9 weeks.
|
0.00%
0/25 • At first administration period of Paclitaxel through the end of third administration period of Paclitaxel, an average of 9 weeks.
|
0.00%
0/32 • At first administration period of Paclitaxel through the end of third administration period of Paclitaxel, an average of 9 weeks.
|
|
Cardiac disorders
Tachyardia
|
6.9%
2/29 • At first administration period of Paclitaxel through the end of third administration period of Paclitaxel, an average of 9 weeks.
|
0.00%
0/25 • At first administration period of Paclitaxel through the end of third administration period of Paclitaxel, an average of 9 weeks.
|
3.1%
1/32 • At first administration period of Paclitaxel through the end of third administration period of Paclitaxel, an average of 9 weeks.
|
|
Nervous system disorders
Tinnitus
|
0.00%
0/29 • At first administration period of Paclitaxel through the end of third administration period of Paclitaxel, an average of 9 weeks.
|
0.00%
0/25 • At first administration period of Paclitaxel through the end of third administration period of Paclitaxel, an average of 9 weeks.
|
3.1%
1/32 • At first administration period of Paclitaxel through the end of third administration period of Paclitaxel, an average of 9 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place