NCT06152471

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 7, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 30, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

November 30, 2023

Status Verified

November 1, 2023

Enrollment Period

1.4 years

First QC Date

October 19, 2023

Last Update Submit

November 28, 2023

Conditions

Early-stage Breast CancerDiarrheaAdverse Drug Event

Keywords

Early Breast cancerAbemaciclib induced diarrea

Outcome Measures

Primary Outcomes (1)

  • 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).

    Three months

Secondary Outcomes (9)

  • Occurrence of abemaciclib induced diarrhea - CTCAE

    Three months

  • QoL using FACT-B

    Three months

  • QoL using FACT-GP5

    Three months

  • QoL using FACIT-D

    Three months

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

    Three months

  • +4 more secondary outcomes

Study Arms (2)

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-flakesDrug: Salovum

Placebo Comparator

PLACEBO COMPARATOR

Placebo, identical to investigational product but without antisecretory factor.

Drug: Placebo

Interventions

SPC-flakesDRUG

Aktive drug

Experimental
SalovumDRUG

Active drug

Experimental
PlaceboDRUG

Placebo drugs

Placebo Comparator

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

General Hospital of Eskilstuna

Eskilstuna, 631 88, Sweden

RECRUITING

General Hospital of Falun

Falun, 791 82, Sweden

RECRUITING

General Hospital of Gävle

Gävle, 801 87, Sweden

NOT YET RECRUITING

University Hospital Örebro

Örebro, 701 85, Sweden

RECRUITING

General Hospital

Sundsvall, 856 43, Sweden

NOT YET RECRUITING

Uppsala University Hospital

Uppsala, 751 85, Sweden

RECRUITING

General Hospital Västerås

Västerås, 721 89, Sweden

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsDiarrheaDrug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsChemically-Induced Disorders

Study Officials

  • Henrik Lindman, MD, PhD

    Uppsala University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Larsson

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
double-blind, placebo controlled
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomization 1:1 to investigational product or placebo
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Coordinating Investigator

Study Record Dates

First Submitted

October 19, 2023

First Posted

November 30, 2023

Study Start

June 7, 2023

Primary Completion

October 31, 2024

Study Completion

March 31, 2025

Last Updated

November 30, 2023

Record last verified: 2023-11

Locations

SE(7)