IMPOWER-QoL: IMPact Of Discontinuing Premedication for WEekly Paclitaxel on bReast Cancer Patient's Quality Of Life

Официальное название

IMPOWER-QoL: IMPact Of Discontinuing Premedication for WEekly Paclitaxel on bReast Cancer Patients' Quality Of Life

Обзор

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.

Вмешательства

• Препарат withdrawal of the premedication
  no premedication

Первичные конечные точки

• The difference in quality of life between weeks 3 and 9 based on the EORTC QLQ-C30 v3.0 questionnaire [Срок оценки: From enrollment (week 3) to week 9 of treatment]

Вторичные конечные точки (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. [Срок оценки: 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 [Срок оценки: at week 3]
• Compare quality of life at week 6 between the two groups based on the EORTC QLQ-C30 v3.0 questionnaire [Срок оценки: At week 6]
• Compare quality of life at week 9 between the two groups based on the EORTC QLQ-C30 v3.0 questionnaire [Срок оценки: at week 9]
• Compare quality of life at week 12 between the two groups based on the EORTC QLQ-C30 v3.0 questionnaire [Срок оценки: At week 12]
• Compare the incidence and severity of adverse events between the two groups using a modified ESAS-r questionnaire. [Срок оценки: From enrollment (week 3) to the end of treatment (week 12)]
• compare the number of patients who had treatment adjustments [Срок оценки: From enrollment (week 3) to the end of treatment (week 12)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07478315 · MP-04-2026-1061

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗