Effect of Salovum™ and SPC-Flakes™ on Abemaciclib-induced Gastrointestinal Toxicity in Early Breast Cancer
NCT06152471 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2023-11-30
Summary
The present study aims to investigate a proactive strategy including Salovum™ and SPC-flakes to prevent the occurrence of abemaciclib-induced diarrhea in patients with early breast cancer.
Conditions
- Early-stage Breast Cancer
- Diarrhea
- Adverse Drug Event
Interventions
- DRUG
-
SPC-flakes
Aktive drug
- DRUG
-
Salovum
Active drug
- DRUG
-
Placebo drugs
Sponsors & Collaborators
-
Henrik Lindman
lead OTHER
Principal Investigators
-
Henrik Lindman, MD, PhD · Uppsala University Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-06-07
- Primary Completion
- 2024-10-31
- Completion
- 2025-03-31
Countries
- Sweden
Study Locations
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