Clinical trial · Interventional
IMPOWER-QoL: IMPact Of Discontinuing Premedication for WEekly Paclitaxel on bReast Cancer Patient's Quality Of Life
IMPOWER-QoL: IMPact Of Discontinuing Premedication for WEekly Paclitaxel on bReast Cancer Patients' Quality Of Life
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| withdrawal of the premedication | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- No paclitaxel premedication
- interventionNames
- Drug: withdrawal of the premedication
- type
- NO_INTERVENTION
- label
- control : standard paclitaxel premedication
- description
- This arm will receive standard paclitaxel premedication : dexamethasone, anti-h1 (diphenhydramine or cetirizine), anti-h2: famotidine
Primary outcomes (1)
- measure
- The difference in quality of life between weeks 3 and 9 based on the EORTC QLQ-C30 v3.0 questionnaire
- timeFrame
- From enrollment (week 3) to week 9 of treatment
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available