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

Sponsor

Henrik Lindman (Other)

Overall Status

Recruiting

CT.gov ID

NCT06152471

Collaborator

(none)

100

Enrollment

Locations

Arms

21.8

Anticipated Duration (Months)

14.3

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Early-stage Breast Cancer Diarrhea Adverse Drug Event	Drug: SPC-flakes Drug: Salovum Drug: Placebo	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomization 1:1 to investigational product or placeboRandomization 1:1 to investigational product or placebo

Masking:

Double (Participant, Investigator)

Masking Description:

double-blind, placebo controlled

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 7, 2023

Anticipated Primary Completion Date :

Oct 31, 2024

Anticipated Study Completion Date :

Mar 31, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	General Hospital of Eskilstuna	Eskilstuna	Sweden	631 88
2	General Hospital of Falun	Falun	Sweden	791 82
3	General Hospital of Gävle	Gävle	Sweden	801 87
4	General Hospital	Sundsvall	Sweden	856 43
5	Uppsala University Hospital	Uppsala	Sweden	751 85
6	General Hospital Västerås	Västerås	Sweden	721 89
7	University Hospital Örebro	Örebro	Sweden	701 85

Sponsors and Collaborators

Henrik Lindman

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Henrik Lindman, Coordinating Investigator, Uppsala University Hospital

ClinicalTrials.gov Identifier:

NCT06152471

Other Study ID Numbers:

Version 1.3, 30May2022

First Posted:

Nov 30, 2023

Last Update Posted:

Nov 30, 2023

Last Verified:

Nov 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Henrik Lindman, Coordinating Investigator, Uppsala University Hospital

Early Breast cancer

Abemaciclib induced diarrea

Additional relevant MeSH terms:

Breast Neoplasms

Diarrhea

Study Results

No Results Posted as of Nov 30, 2023