Improvement of Quality of Life Through Supportive Treatments for Hormone Therapy - Related Sympto… (NCT06407401) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Improvement of Quality of Life Through Supportive Treatments for Hormone Therapy - Related Symptoms in Patients With Early Breast Cancer
399 participantsStarted 2024-12
Plain-language summary
This study is a pragmatic international, multicenter, randomized, open label 3- arm trial of standard care vs. two pharmacological interventions: duloxetine or furosemide in patients with stage I-III ER+/HER2- early breast cancer with joint, muscle and/or bone pain caused by the endocrine therapy.
The purpose of the BC-QOL trial is to find out whether treatment with duloxetine or furosemide, given while patients are on treatment with endocrine therapy, is active in improving quality of life (QoL), specifically by improving joint, muscle and/or bone pain caused by the endocrine therapy (based on EORTC QLQ-BR42 skeletal scale).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria:
* Female (both pre- and postmenopausal) or male patients
* Age ≥18 years
* Ongoing adjuvant ET (tamoxifen or OFS plus tamoxifen or OFS plus AI or AI ) for ER positive HER2 negative breast cancer stages I-III
* Patients must have received at least 3 months and up to 3 years of ET and planned to continue ET during the study conduction
* Present endocrine therapy related MSK pain (arthralgia and/or bone pain and/or myalgias), evaluated by the treating clinician as at least grade 2 CTCAE V5.0 for, at least, 4 weeks before enrolment, at the time of the clinic visit:
* Grade 2: moderate pain; limiting instrumental activities daily living (ADL)
* Grade 3: severe pain; limiting activities self-care ADL
* Previous chemotherapy is allowed if completed at least 3 months before enrolment
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
* Adequate organ function
* Completed baseline assessment of patient-reported questionnaires (EORTC QLQ-C30 and EORTC QLQ breast module)
* Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations
* Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 7 days prior to the first dose of study treatment.
Note: women of childbearing potential are defined as premenopausal females capable of becoming pregnant (i.e., females who have had any evidence of menses in the past 12 months, except for those who had …
What they're measuring
1
Endocrine therapy related musculoskeletal pain
Timeframe: 3 months
Trial details
NCT IDNCT06407401
SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC