Trial · NCT04862585
Safely Stopping Pre-medications in Patients With Breast Cancer Who Are Receiving Paclitaxel
NCT04862585, Phase 2, Phase 3, Completed, Ohio State University Comprehensive Cancer Center; results first posted 2025-08-20
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Safely Stopping Pre-medications in Patients With Breast Cancer Who Are Receiving Paclitaxel. Trials, record NCT04862585. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04862585
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safely Stopping Pre-medications in Patients With Breast Cancer Who Are Receiving Paclitaxel
- NCT number
- NCT04862585
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 130 participants, actual
- Lead sponsor
- Ohio State University Comprehensive Cancer Center
- Conditions
Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Breast Carcinoma, Prognostic Stage 0 Breast Cancer AJCC v8, Prognostic Stage I Breast Cancer AJCC v8, Prognostic Stage IA Breast Cancer AJCC v8, Prognostic Stage IB Breast Cancer AJCC v8, Prognostic Stage II Breast Cancer AJCC v8, Prognostic Stage IIA Breast Cancer AJCC v8, Prognostic Stage IIB Breast Cancer AJCC v8, Prognostic Stage III Breast Cancer AJCC v8, Prognostic Stage IIIA Breast Cancer AJCC v8, Prognostic Stage IIIB Breast Cancer AJCC v8, Prognostic Stage IIIC Breast Cancer AJCC v8, Prognostic Stage IV Breast Cancer AJCC v8
- Interventions
- Cimetidine, Dexamethasone, Diphenhydramine, Famotidine, Paclitaxel, Quality-of-Life Assessment, Ranitidine
- First posted
- 2021-04-28
- Last updated
- 2025-08-20
- Results first posted
- 2025-08-20
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Patients With Grade 2 or Greater Reactions That Require Parenteral Rescue Medications to Treat an Infusion Hypersensitivity Reaction (HSR) After the First 2 Doses of Paclitaxel With or Without Continued Premedication Dosing | Up to 2 years and 8 months | The proportion of patients having infusion HSR of grade 2 or greater requiring parental treatment (rescue medications) will be estimated along with a 95% confidence interval. The difference in proportions of patients with grade 2 or greater infusion HSR needing rescue medication will be estimated along with a 95% confidence interval using the Z-test of normal approximations of the binomial distributions. As a sensitivity analysis, will repeat the analysis including patients assigned to the discontinuation arm but decided to restart pre-medications and patients assigned to the continuation arm but demanded to have premedications discontinued as having experienced HSR. |
| Secondary | Correlation Between Abbreviated Premedication Regimen Results to Quality of Life (QoL) | Up to 2 years and 8 months | Will determine whether an abbreviated pre-medication regimen results in an improvement in patient-reported quality of life, as measured by an 11-point numerical analog scale (scores range from 0-10 with higher values representing a worse QoL). Both "undesirable appetite increase" and "reported rash" will be rated on this 11-point scale from 0 to 10 with higher values representing a worse undesirable appetite or a worse rash. The "worst reported undesirable appetite increase" and "worst reported rash" scores representing the highest mean score reported at an individual time point for each arm, will be summarized. In addition the change from baseline will be summarized by mean separately by treatment arm. Data will be captured every day, for one week after each dose of chemotherapy. |
| Other | Differences in a Number of Symptoms That Might be Improved, or Worsened, by the Hypersensitivity Prevention Drugs | Up to 6 years | Each symptom will be summarized by median (range) at each time point by treatment arm and the weekly average will be compared between arms using the Wilcoxon rank sum test. |
| Other | The Number of Patients Who, After Discontinuing Pre-medications, Request That the Premedications be Resumed to Ameliorate Side-effects That the Patient Thinks Have Worsened Since Premedications Were Stopped (i.e. Nausea, Rash, Arthralgia) | Up to 6 years | The frequency and percentages of patients who, after discontinuing pre-medications, request that the pre-medications be resumed to ameliorate side-effects that the patient thinks have worsened since pre-medications were stopped (i.e. nausea, rash, arthralgia) will be summarized. |
| Other | Weight Changes Across Study Periods for Both Arms of the Study | Up to 6 years | Weight changes over time will be summarized at each time point using mean (standard deviation) and plotted by treatment arm. Weight change from baseline to 10 weeks post-randomization will be compared between arms that receive weekly paclitaxel using a t-test of two independent samples. |
| Other | The Impact of Patient Self-reported Allergies | Up to 6 years | Will report the impact of patient self-reported allergies, prior to starting paclitaxel (2 or more versus 3 or less), on the incidence of infusion HSR and rescue medication usage. Frequency of patient self-reported allergies (2 or more versus less) on the incidence of infusion HSR and rescue medication usage will be tabulated. |
| Other | Patient Outcomes | Up to 6 years | The rates of rescue medication by arms will be estimated by race/ethnicity group to explore whether there is a differential effect from stopping hypersensitivity reaction by race/ethnicity. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Patients With Grade 2 or Greater Reactions That Require Parenteral Rescue Medications to Treat an Infusion Hypersensitivity Reaction (HSR) After the First 2 Doses of Paclitaxel With or Without Continued Premedication Dosing | Up to 2 years and 8 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Correlation Between Abbreviated Premedication Regimen Results to Quality of Life (QoL) | Up to 2 years and 8 months | score on a scale | MEAN | |
| OTHER_PRE_SPECIFIED | Differences in a Number of Symptoms That Might be Improved, or Worsened, by the Hypersensitivity Prevention Drugs | Up to 6 years | |||
| OTHER_PRE_SPECIFIED | The Number of Patients Who, After Discontinuing Pre-medications, Request That the Premedications be Resumed to Ameliorate Side-effects That the Patient Thinks Have Worsened Since Premedications Were Stopped (i.e. Nausea, Rash, Arthralgia) | Up to 6 years | |||
| OTHER_PRE_SPECIFIED | Weight Changes Across Study Periods for Both Arms of the Study | Up to 6 years | |||
| OTHER_PRE_SPECIFIED | The Impact of Patient Self-reported Allergies | Up to 6 years | |||
| OTHER_PRE_SPECIFIED | Patient Outcomes | Up to 6 years |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Proportion of Patients With Grade 2 or Greater Reactions That Require Parenteral Rescue Medications to Treat an Infusion Hypersensitivity Reaction (HSR) After the First 2 Doses of Paclitaxel With or Without Continued Premedication Dosing | Arm I (Paclitaxel, Pre-medications) | 0 | Participants | ||
Proportion of Patients With Grade 2 or Greater Reactions That Require Parenteral Rescue Medications to Treat an Infusion Hypersensitivity Reaction (HSR) After the First 2 Doses of Paclitaxel With or Without Continued Premedication Dosing | Arm II (Paclitaxel) | 1 | Participants | ||
| Correlation Between Abbreviated Premedication Regimen Results to Quality of Life (QoL) | Arm I (Paclitaxel, Pre-medications) | Worst reported undesirable appetite increase | 2.5 | 95% Confidence Interval 1.77 to 3.23 | score on a scale |
| Correlation Between Abbreviated Premedication Regimen Results to Quality of Life (QoL) | Arm II (Paclitaxel) | Worst reported undesirable appetite increase | 1 | 95% Confidence Interval 0.54 to 1.46 | score on a scale |
| Correlation Between Abbreviated Premedication Regimen Results to Quality of Life (QoL) | Arm I (Paclitaxel, Pre-medications) | Worst reported rash | 3.3 | 95% Confidence Interval 2.58 to 4.12 | score on a scale |
| Correlation Between Abbreviated Premedication Regimen Results to Quality of Life (QoL) | Arm II (Paclitaxel) | Worst reported rash | 2.3 | 95% Confidence Interval 1.48 to 3.13 | score on a scale |
| Correlation Between Abbreviated Premedication Regimen Results to Quality of Life (QoL) | Arm I (Paclitaxel, Pre-medications) | Change in undesirable appetite increase from baseline | 1.7 | 95% Confidence Interval 1.08 to 2.36 | score on a scale |
| Correlation Between Abbreviated Premedication Regimen Results to Quality of Life (QoL) | Arm II (Paclitaxel) | Change in undesirable appetite increase from baseline | 0.5 | 95% Confidence Interval 0.15 to 0.80 | score on a scale |
| Correlation Between Abbreviated Premedication Regimen Results to Quality of Life (QoL) | Arm I (Paclitaxel, Pre-medications) | Change in reported rash from baseline | 2.9 | 95% Confidence Interval 2.11 to 3.72 | score on a scale |
| Correlation Between Abbreviated Premedication Regimen Results to Quality of Life (QoL) | Arm II (Paclitaxel) | Change in reported rash from baseline | 1.9 | 95% Confidence Interval 1.13 to 2.59 | score on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (Paclitaxel, Pre-medications) | 50 | |
| Overall Study | STARTED | Arm II (Paclitaxel) | 48 | |
| Overall Study | COMPLETED | Arm I (Paclitaxel, Pre-medications) | 46 | |
| Overall Study | COMPLETED | Arm II (Paclitaxel) | 43 | |
| Overall Study | NOT COMPLETED | Arm I (Paclitaxel, Pre-medications) | 4 | |
| Overall Study | NOT COMPLETED | Arm II (Paclitaxel) | 5 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (Paclitaxel, Pre-medications) | 0 | 0 |
| Total, all-cause mortality | Arm II (Paclitaxel) | 0 | 0 |
| Total, other adverse events | Arm I (Paclitaxel, Pre-medications) | 0 | 0 |
| Total, other adverse events | Arm II (Paclitaxel) | 0 | 0 |
| Total, serious adverse events | Arm I (Paclitaxel, Pre-medications) | 0 | 0 |
| Total, serious adverse events | Arm II (Paclitaxel) | 0 | 0 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
Arm I (Paclitaxel, Pre-medications) vs Arm II (Paclitaxel): Proportion of Patients With Grade 2 or Greater Reactions That Require Parenteral Rescue Medications to Treat an Infusion Hypersensitivity Reaction (HSR) After the First 2 Doses of Paclitaxel With or Without Continued Premedication Dosing |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04862585
GET https://conductscience.org/api/trials/v1/NCT04862585/registered