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

November 28, 2023 updated by: Henrik Lindman

A Randomized Double-blind Placebo Controlled Phase 3 Trial on the Effect of Salovum™ and SPC-Flakes™ on Abemaciclib-induced Gastrointestinal Toxicity in Early Breast Cancer - the ASF-BC Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental

Salovum egg powder high in antisecretory factor, 4 g/sachet. Four sachets, ie 16 gr q 8 hours for 6 days before start of abemaciclib

SPC-flakes flat dose 75gr/day in parallel and during first 12 weeks of treatment with abemaciclib
Drug: SPC-flakes
Aktive drug
Drug: Salovum
Active drug
Placebo Comparator: Placebo Comparator
Placebo, identical to investigational product but without antisecretory factor.
Drug: Placebo
Placebo drugs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of Abemaciclib induced diarrhea - STIDAT
Time Frame: Three months
● Occurrence of any-grade (mild, moderate, severe) diarrhea according to the Systemic Treatment-Induced Diarrhea Assessment Tool (STIDAT; patient-reported outcome).
Three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of abemaciclib induced diarrhea - CTCAE
Time Frame: Three months
Occurrence of any-grade diarrhea according to CTCAE v. 5.0
Three months
QoL using FACT-B
Time Frame: Three months
The tool is FACT-B
Three months
QoL using FACT-GP5
Time Frame: Three months
The tool is FACT-GP5
Three months
QoL using FACIT-D
Time Frame: Three months
The tool is FACIT-D
Three months
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] besides diarrhea.
Time Frame: Three months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, besides diarrhea.
Three months
Rate of patients that stop or interrupt treatment with investigational products
Time Frame: Three months
Rate of patients that stop or interrupt treatment with Salovum and SPC-flakes/placebo during planned study time.
Three months
Rate of patients that stop or interrupt treatment with abemaciclib
Time Frame: Two years
Rate of patients that stop or interrupt treatment with abemaciclib during the planned treatment time of two years.
Two years
Sick leave
Time Frame: Two years
Sick leave duration
Two years
Breast cancer recurrence
Time Frame: Two years
Breast cancer recurrence
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henrik Lindman

Investigators

  • Principal Investigator: Henrik Lindman, MD, PhD, Uppsala University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2023

Primary Completion (Estimated)

October 31, 2024

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

October 19, 2023

First Submitted That Met QC Criteria

November 28, 2023

First Posted (Actual)

November 30, 2023

Study Record Updates

Last Update Posted (Actual)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Version 1.3, 30May2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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