Trials / Not Yet Recruiting
Not Yet RecruitingNCT07478315
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
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- Charles LeMoyne Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | withdrawal of the premedication | no premedication |
Timeline
- Start date
- 2026-03-15
- Primary completion
- 2026-12-31
- Completion
- 2026-12-31
- First posted
- 2026-03-17
- Last updated
- 2026-03-17
Source: ClinicalTrials.gov record NCT07478315. Inclusion in this directory is not an endorsement.