IMPOWER-QoL: IMPact Of Discontinuing Premedication for WEekly Paclitaxel on bReast Cancer Patient's Quality Of Life
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: withdrawal of the premedication.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
IMPOWER-QoL: IMPact Of Discontinuing Premedication for WEekly Paclitaxel on bReast Cancer Patients' Quality Of Life
Overview
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.
Interventions
- Drug withdrawal of the premedication
no premedication
Primary outcome measures
- 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]
Secondary outcome measures (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. [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)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07478315 · MP-04-2026-1061