Breast Cancer
Conditions
Keywords
Breast cancer, Paclitaxel, premedication, quality of life, hypersensitivity reaction, dexamethasone, non-metastatic, weekly paclitaxel
Brief 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.
Interventions
DRUGwithdrawal of the premedication
no premedication
Sponsors
Charles LeMoyne Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Prospective, randomized, open-label, multicenter comparative study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The difference in quality of life between weeks 3 and 9 based on the EORTC QLQ-C30 v3.0 questionnaire | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | From enrollment (week 3) to the end of treatment (week 12) | 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. |
| Compare quality of life at week 3 between the two groups based on the EORTC QLQ-C30 v3.0 questionnaire | at week 3 | 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 6 between the two groups based on the EORTC QLQ-C30 v3.0 questionnaire | At week 6 | 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 9 between the two groups based on the EORTC QLQ-C30 v3.0 questionnaire | at week 9 | 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 12 between the two groups based on the EORTC QLQ-C30 v3.0 questionnaire | At week 12 | Compare quality of life at week 12 between the two groups based on the EORTC QLQ-C30 v3.0 questionnaire |
| Compare the incidence and severity of adverse events between the two groups using a modified ESAS-r questionnaire. | From enrollment (week 3) to the end of treatment (week 12) | 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. |
| compare the number of patients who had treatment adjustments | From enrollment (week 3) to the end of treatment (week 12) | 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 |
Contacts
CONTACTBarbara Vadnais
CONTACTLea Desbiens-Léger
Outcome results
None listed