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

NCT07478315 | Not Yet Recruiting

• 1 other identifier: MP-04-2026-1061
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer

Keywords

Breast cancer; Paclitaxel; premedication; quality of life; hypersensitivity reaction; dexamethasone; non-metastatic; weekly paclitaxel

Outcome Measures

Primary Outcomes (1)

• The difference in quality of life between weeks 3 and 9 based on the EORTC QLQ-C30 v3.0 questionnaire

  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.

  From enrollment (week 3) to week 9 of treatment

Secondary Outcomes (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.

  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

  at week 3

• 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 9 between the two groups based on the EORTC QLQ-C30 v3.0 questionnaire

  at week 9

• Compare quality of life at week 12 between the two groups based on the EORTC QLQ-C30 v3.0 questionnaire

  At week 12

Other Outcomes (1)

• Reasons for treatment adjustments

  From enrollment (week 3) to the end of treatment (week 12)

Study Arms (2)

No paclitaxel premedication

EXPERIMENTAL

Drug: withdrawal of the premedication

control : standard paclitaxel premedication

NO INTERVENTION

This arm will receive standard paclitaxel premedication : dexamethasone, anti-h1 (diphenhydramine or cetirizine), anti-h2: famotidine

Interventions

withdrawal of the premedication DRUG

no premedication

No paclitaxel premedication

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Charles LeMoyne Hospital: lead

MeSH Terms

Conditions

Breast Neoplasms; Hypersensitivity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Immune System Diseases

Central Study Contacts

Barbara Vadnais

CONTACT

1-450-466-5000; barbara.vadnais.cisssmc16@ssss.gouv.qc.ca

Lea Desbiens-Léger

CONTACT

14504665000; lea.desbiens-leger.cisssmc16@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective, randomized, open-label, multicenter comparative study

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: March 17, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share