IMPOWER-QoL: IMPact Of Discontinuing Premedication for WEekly Paclitaxel on bReast Cancer Patient's Quality Of Life

March 13, 2026 updated by: Barbara Vadnais, Charles LeMoyne Hospital

IMPOWER-QoL: IMPact Of Discontinuing Premedication for WEekly Paclitaxel on bReast Cancer Patients' Quality Of Life

Usually, paclitaxel administration is preceded by premedication, which consists of a set of medications intended to prevent allergic reactions during chemotherapy. This practice is very common, even though scientific studies show that it is safe to discontinue premedication if no allergic reaction occurs after the first two doses of paclitaxel. Moreover, when given during all 12 doses of weekly chemotherapy, premedication could negatively affect quality of life (for example, insomnia followed by significant fatigue may occur several days after taking dexamethasone). However, no study has yet evaluated whether stopping premedication after two well-tolerated doses could improve the quality of life of patients receiving paclitaxel.

Our research project therefore aims to concretely evaluate the impact of discontinuing this premedication on the quality of life of patients with non-metastatic breast cancer. More specifically, we want to compare the quality of life between two groups of patients. The first group will include patients whose premedication is discontinued starting from the third dose of paclitaxel if they did not experience a reaction during the first two doses. The second group will include patients who continue to receive the premedication given during the first cycles, as is usual practice.

The study will also monitor the occurrence of adverse events or side effects (whether related to premedication or paclitaxel itself), as well as changes in chemotherapy dosing if applicable. It is sometimes necessary to reduce chemotherapy doses due to adverse effects, even when they originate from premedication, since it can be difficult to determine the contribution of each medication.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • any person aged 18 years or older
  • diagnosed with non-metastatic breast cancer
  • receiving weekly paclitaxel monotherapy for 12 weeks in the outpatient oncology clinics at one of the participating hospital centers
  • providing signed informed consent

Exclusion Criteria:

  • individuals who have experienced a grade 1 or higher hypersensitivity reaction according to CTCAE criteria (Appendix 3) during one of the first two doses of paclitaxel
  • individuals with metastatic cancer
  • individuals using chronic oral corticosteroids for more than 2 weeks,
  • individuals with a contraindication to the use of any of the premedication agents or their ingredients,
  • pregnant women,
  • individuals with a language or comprehension barrier to the questionnaires available in French or English, and
  • individuals participating in another clinical study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: No paclitaxel premedication
Drug: withdrawal of the premedication
no premedication
No Intervention: control : standard paclitaxel premedication
This arm will receive standard paclitaxel premedication : dexamethasone, anti-h1 (diphenhydramine or cetirizine), anti-h2: famotidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The difference in quality of life between weeks 3 and 9 based on the EORTC QLQ-C30 v3.0 questionnaire
Time Frame: From enrollment (week 3) to week 9 of treatment

Compare the difference in quality of life between weeks 3 and 9 between patients receiving premedication and those not receiving premedication, among patients with non-metastatic breast cancer receiving weekly paclitaxel for 12 weeks.

The quality of life will be assessed using the validated EORTC-QLQ-C30 version 3.0 questionnaire which is designed to measure the quality of life (physical, psychological, and social functioning) in cancer patients.
From enrollment (week 3) to week 9 of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the incidence and grade of weekly paclitaxel hypersensitivity reactions between the two groups. We will use the CTCAE v6.0 published by the National Cancer Institute (NCI) to grade the hypersensitivity reaction.
Time Frame: From enrollment (week 3) to the end of treatment (week 12)
Compare the incidence and grade of weekly hypersensitivity reactions between the two groups. We will use the CTCAE v6.0 published by the National Cancer Institute (NCI) to grade the hypersensitivity reaction.
From enrollment (week 3) to the end of treatment (week 12)
Compare quality of life at week 3 between the two groups based on the EORTC QLQ-C30 v3.0 questionnaire
Time Frame: at week 3
Compare quality of life at week 3 between the two groups based on the EORTC QLQ-C30 v3.0 questionnaire
at week 3
Compare quality of life at week 6 between the two groups based on the EORTC QLQ-C30 v3.0 questionnaire
Time Frame: At week 6
Compare quality of life at week 6 between the two groups based on the EORTC QLQ-C30 v3.0 questionnaire
At week 6
Compare quality of life at week 9 between the two groups based on the EORTC QLQ-C30 v3.0 questionnaire
Time Frame: at week 9
Compare quality of life at week 9 between the two groups based on the EORTC QLQ-C30 v3.0 questionnaire.
at week 9
Compare quality of life at week 12 between the two groups based on the EORTC QLQ-C30 v3.0 questionnaire
Time Frame: At week 12
Compare quality of life at week 12 between the two groups based on the EORTC QLQ-C30 v3.0 questionnaire
At week 12
Compare the incidence and severity of adverse events between the two groups using a modified ESAS-r questionnaire.
Time Frame: From enrollment (week 3) to the end of treatment (week 12)

Compare the incidence of adverse events between the two groups (both from paclitaxel and from premedication in the premedication group).

We will use the modified ESAS-r questionnaire. The ESAS-r (Edmonton Symptom Assessment System-Revised) is a validated, 10-item tool used to assess the severity of common symptoms in patients with cancer or those receiving palliative care. The original ESAS-r questionnaire measures 9 core symptoms-plus one blank space for a patient-specific symptom. We will add 16 questions about symptoms that may be influenced by the addition or withdrawal of premedication.
From enrollment (week 3) to the end of treatment (week 12)
compare the number of patients who had treatment adjustments
Time Frame: From enrollment (week 3) to the end of treatment (week 12)
Compare the number of patients who had chemotherapy dose adjustments during treatment, the number of patients who completed their planned 12 treatments, the average number of treatments received, the average dose reduction, and the number of treatment delays between the two groups
From enrollment (week 3) to the end of treatment (week 12)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reasons for treatment adjustments
Time Frame: From enrollment (week 3) to the end of treatment (week 12)
Exploratorily, compare the reasons for dose adjustments and reasons for not completing the 12 treatments between the two groups
From enrollment (week 3) to the end of treatment (week 12)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charles LeMoyne Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 15, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

January 7, 2026

First Submitted That Met QC Criteria

March 13, 2026

First Posted (Actual)

March 17, 2026

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 13, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MP-04-2026-1061

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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