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

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.

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.