Effect of Salovum™ and SPC-Flakes™ on Abemaciclib-induced Gastrointestinal Toxicity in Early Breast Cancer

Launched by HENRIK LINDMAN · Nov 28, 2023

Keywords

ClinConnect Summary

This clinical trial is studying whether two products, Salovum™ and SPC-Flakes™, can help prevent diarrhea caused by a medication called abemaciclib in patients with early-stage breast cancer. Diarrhea is a common side effect of abemaciclib, and this study aims to find a way to reduce that discomfort for patients starting this treatment.

To be eligible for the trial, participants must be at least 18 years old and have a confirmed diagnosis of early breast cancer that is not spreading to other parts of the body. They should be preparing to start abemaciclib as part of their treatment plan. Participants will need to provide informed consent and will be closely monitored throughout the study to see if the Salovum™ and SPC-Flakes™ effectively help manage diarrhea. It's important to note that individuals with certain health issues or previous exposure to the study products may not be suitable for participation. Overall, this trial is an important step in improving the comfort and quality of life for those undergoing treatment for breast cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 18 years.
• • Histologically confirmed diagnosis of luminal breast cancer.
• • No clinical evidence of metastatic disease.
• • Planned to start abemaciclib in adjuvant setting (according to current national guidelines).
• • Signed informed consent.
• Exclusion Criteria:
• • Contraindications to the investigational product, e g known or suspected hypersensitivity to the investigational products or expected inability to their use in accordance with the protocol.
• • Lack of suitability for participation in the study, e g expected difficulties to follow the protocol procedures, as judged by the investigator.
• • Prior exposure to abemaciclib.
• • Prior exposure to Salovum or SPC-flakes.
• • Past or present history of inflammatory bowel disease.