Breast CancerNCT07478315
IMPOWER-QoL: IMPact Of Discontinuing Premedication for WEekly Paclitaxel on bReast Cancer Patient's Quality Of Life
A study testing withdrawal of the premedication in people with Breast Cancer, run by Charles LeMoyne Hospital.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- withdrawal of the premedication
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Breast Cancer
- Being tested
- withdrawal of the premedication
- Keywords
- Breast cancer, Paclitaxel, premedication, quality of life, hypersensitivity reaction, dexamethasone, non-metastatic, weekly paclitaxel
- Medical subject headings
- Breast Neoplasms, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
withdrawal of the premedicationDrug
no premedication
| Study group | Role | What they receive |
|---|---|---|
| No paclitaxel premedication | Experimental | Not described Receives: Drug: withdrawal of the premedication |
| control : standard paclitaxel premedication | No intervention | This arm will receive standard paclitaxel premedication : dexamethasone, anti-h1 (diphenhydramine or cetirizine), anti-h2: famotidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in quality of life between weeks 3 and 9 based on the EORTC QLQ-C30 v3.0 questionnaire
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.
Measured: From enrollment (week 3) to week 9 of treatment
Secondary outcomes (7)
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.
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.
Measured: 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
Compare quality of life at week 3 between the two groups based on the EORTC QLQ-C30 v3.0 questionnaire
Measured: at week 3
Compare quality of life at week 6 between the two groups based on the EORTC QLQ-C30 v3.0 questionnaire
Compare quality of life at week 6 between the two groups based on the EORTC QLQ-C30 v3.0 questionnaire
Measured: At week 6
Compare quality of life at week 9 between the two groups based on the EORTC QLQ-C30 v3.0 questionnaire
Compare quality of life at week 9 between the two groups based on the EORTC QLQ-C30 v3.0 questionnaire.
Measured: at week 9
Compare quality of life at week 12 between the two groups based on the EORTC QLQ-C30 v3.0 questionnaire
Compare quality of life at week 12 between the two groups based on the EORTC QLQ-C30 v3.0 questionnaire
Measured: At week 12
Compare the incidence and severity of adverse events between the two groups using a modified ESAS-r questionnaire.
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.
Measured: From enrollment (week 3) to the end of treatment (week 12)
compare the number of patients who had treatment adjustments
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
Measured: From enrollment (week 3) to the end of treatment (week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start15 Mar 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, open-label, multicenter comparative study
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles LeMoyne Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara Vadnais, Charles LeMoyne Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07478315
- Sponsor's protocol ID
- MP-04-2026-1061
- Status last verified
- Mar 2026
- First submitted
- 7 Jan 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMPOWER-QoL: IMPact Of Discontinuing Premedication for WEekly Paclitaxel on bReast Cancer Patients' Quality Of Life
- ClinicalTrials.gov ID
- NCT07478315
- Acronym / sponsor ID
- MP-04-2026-1061
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Paclitaxel, premedication, quality of life, hypersensitivity reaction, dexamethasone, non-metastatic, weekly paclitaxel
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Charles LeMoyne HospitalUniversity, hospital or other
- Study start
- 15 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, randomized, open-label, multicenter comparative study
| Arm | Type | Receives |
|---|---|---|
| No paclitaxel premedication | Experimental | Drug: withdrawal of the premedication |
| control : standard paclitaxel premedication | No intervention | –This arm will receive standard paclitaxel premedication : dexamethasone, anti-h1 (diphenhydramine or cetirizine), anti-h2: famotidine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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,
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 |
|---|---|---|
| withdrawal of the premedicationno premedication | Drug | No paclitaxel premedication |
Primary outcome
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.
7 secondary outcomes
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 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 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 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 12 between the two groups based on the EORTC QLQ-C30 v3.0 questionnaire
Time frame: 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 number of patients who had treatment adjustments
Time frame: From enrollment (week 3) to the end of treatment (week 12)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing withdrawal of the premedication in people with Breast Cancer, run by Charles LeMoyne Hospital.
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 4 inclusion and 7 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: opening soon, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Barbara Vadnais (1-450-466-5000 ext. 3464, barbara.vadnais.cisssmc16@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2026.