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

NCT ID: NCT06152471

Last Updated: 2023-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-07

Study Completion Date

2025-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Early-stage Breast Cancer Diarrhea Adverse Drug Event

Keywords

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Early Breast cancer Abemaciclib induced diarrea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomization 1:1 to investigational product or placebo
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
double-blind, placebo controlled

Study Groups

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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

Group Type EXPERIMENTAL

SPC-flakes

Intervention Type DRUG

Aktive drug

Salovum

Intervention Type DRUG

Active drug

Placebo Comparator

Placebo, identical to investigational product but without antisecretory factor.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo drugs

Interventions

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SPC-flakes

Aktive drug

Intervention Type DRUG

Salovum

Active drug

Intervention Type DRUG

Placebo

Placebo drugs

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Henrik Lindman

OTHER

Sponsor Role lead

Responsible Party

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Henrik Lindman

Coordinating Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Henrik Lindman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Uppsala University Hospital

Locations

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General Hospital of Eskilstuna

Eskilstuna, , Sweden

Site Status RECRUITING

General Hospital of Falun

Falun, , Sweden

Site Status RECRUITING

General Hospital of Gävle

Gävle, , Sweden

Site Status NOT_YET_RECRUITING

University Hospital Örebro

Örebro, , Sweden

Site Status RECRUITING

General Hospital

Sundsvall, , Sweden

Site Status NOT_YET_RECRUITING

Uppsala University Hospital

Uppsala, , Sweden

Site Status RECRUITING

General Hospital Västerås

Västerås, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Maria Larsson

Role: CONTACT

Phone: +46 18 611 39 45

Email: [email protected]

Facility Contacts

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Andreas Nearchou, MD

Role: primary

Greger Nilsson, MD, PhD

Role: primary

Olga Del Val Muñoz, MD

Role: primary

Antonis Valachis, MD, PhD

Role: primary

Anna-Karin Wennstig, MD, PhD

Role: primary

Henrik Lindman, MD, PhD

Role: primary

Cecilia Nilsson, MD, PhD

Role: primary

Other Identifiers

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Version 1.3, 30May2022

Identifier Type: -

Identifier Source: org_study_id