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

Henrik Lindman100 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Early-stage Breast Cancer Diarrhea Adverse Drug Event

Interventions

SPC-flakesDRUG

Aktive drug

SalovumDRUG

Active drug

PlaceboDRUG

Placebo drugs

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (7)

General Hospital of Eskilstuna

Eskilstuna, Sweden

RECRUITING

General Hospital of Falun

Falun, Sweden

RECRUITING

General Hospital of Gävle

Gävle, Sweden

Outcomes

Primary Outcomes

Occurrence of Abemaciclib induced diarrhea - STIDAT

● Occurrence of any-grade (mild, moderate, severe) diarrhea according to the Systemic Treatment-Induced Diarrhea Assessment Tool (STIDAT; patient-reported outcome).

Time frame: Three months

Secondary Outcomes

Occurrence of abemaciclib induced diarrhea - CTCAE

Occurrence of any-grade diarrhea according to CTCAE v. 5.0

Time frame: Three months

QoL using FACT-B

The tool is FACT-B

Time frame: Three months

QoL using FACT-GP5

The tool is FACT-GP5

Time frame: Three months

QoL using FACIT-D

The tool is FACIT-D

Time frame: Three months

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] besides diarrhea.

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, besides diarrhea.

Time frame: Three months

Rate of patients that stop or interrupt treatment with investigational products

Rate of patients that stop or interrupt treatment with Salovum and SPC-flakes/placebo during planned study time.

Time frame: Three months

Rate of patients that stop or interrupt treatment with abemaciclib

Rate of patients that stop or interrupt treatment with abemaciclib during the planned treatment time of two years.

Central Contacts

Maria Larsson

CONTACT

+46 18 611 39 45 maria.b.larsson@akademiska.se

Data from ClinicalTrials.gov

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