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

Last updated: November 28, 2023
Sponsor: Henrik Lindman
Overall Status: Active - Recruiting

Phase

3

Condition

Colic

Lactose Intolerance

Hyponatremia

Treatment

SPC-flakes

Placebo

Salovum

Clinical Study ID

NCT06152471
Version 1.3, 30May2022
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 nationalguidelines).
  • Signed informed consent.

Exclusion

Exclusion Criteria:

  • Contraindications to the investigational product, e g known or suspectedhypersensitivity to the investigational products or expected inability to their use inaccordance with the protocol.
  • Lack of suitability for participation in the study, e g expected difficulties tofollow 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.

Study Design

Total Participants: 100
Treatment Group(s): 3
Primary Treatment: SPC-flakes
Phase: 3
Study Start date:
June 07, 2023
Estimated Completion Date:
March 31, 2025

Study Description

In patients with high-risk luminal breast cancer, the addition of CDK 4/6-inhibitor abemaciclib to adjuvant endocrine therapy for two years has been associated with improved disease-free survival and is now recommended from national and international guidelines as the preferred treatment strategy for this patient group. However, patients treated with abemaciclib have higher risk of diarrhea which primarily occurs during the first three months from treatment initiation and seems to impact patients' quality of life. As a result, early and proactive strategies to reduce the occurrence of diarrhea from the initiation of abemaciclib should be investigated to ensure that patients in whom adjuvant abemaciclib is recommended can complete their treatment as planned.

Connect with a study center

  • General Hospital of Eskilstuna

    Eskilstuna, 631 88
    Sweden

    Active - Recruiting

  • General Hospital of Falun

    Falun, 791 82
    Sweden

    Active - Recruiting

  • General Hospital of Gävle

    Gävle, 801 87
    Sweden

    Site Not Available

  • General Hospital

    Sundsvall, 856 43
    Sweden

    Site Not Available

  • Uppsala University Hospital

    Uppsala, 751 85
    Sweden

    Active - Recruiting

  • General Hospital Västerås

    Västerås, 721 89
    Sweden

    Active - Recruiting

  • University Hospital Örebro

    Örebro, 701 85
    Sweden

    Active - Recruiting

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