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

Phase 3

Recruiting

• Conditions: Diarrhea; Adverse Drug Event; Early-stage Breast Cancer
• Interventions: Drug: SPC-flakes; Drug: Placebo; Drug: Salovum

• Registration Number: NCT06152471
• Lead Sponsor: Henrik Lindman

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.

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 Timeline

• Study Start: 2023-06-07
• Study First Submitted: 2023-10-19
• Status Verified: 2023-11
• Study First Submitted QC: 2023-11-28
• Last Update Submitted: 2023-11-28
• Study First Posted: 2023-11-30
• Last Update Posted: 2023-11-30
• Primary Completion: 2024-10-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	SPC-flakes	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
Experimental	Salovum	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
Placebo Comparator	Placebo	Placebo, identical to investigational product but without antisecretory factor.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (7)

General Hospital of Eskilstuna; 🇸🇪 Eskilstuna, Sweden

General Hospital of Falun; 🇸🇪 Falun, Sweden

General Hospital of Gävle; 🇸🇪 Gävle, Sweden

General Hospital; 🇸🇪 Sundsvall, Sweden

Uppsala University Hospital; 🇸🇪 Uppsala, Sweden

General Hospital Västerås; 🇸🇪 Västerås, Sweden

University Hospital Örebro; 🇸🇪 Örebro, Sweden