Trial Title:
Effect of Salovum™ and SPC-Flakes™ on Abemaciclib-induced Gastrointestinal Toxicity in Early Breast Cancer
NCT ID:
NCT06152471
Condition:
Early-stage Breast Cancer
Diarrhea
Adverse Drug Event
Conditions: Official terms:
Breast Neoplasms
Diarrhea
Drug-Related Side Effects and Adverse Reactions
Conditions: Keywords:
Early Breast cancer
Abemaciclib induced diarrea
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Randomization 1:1 to investigational product or placebo
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Masking description:
double-blind, placebo controlled
Intervention:
Intervention type:
Drug
Intervention name:
SPC-flakes
Description:
Aktive drug
Arm group label:
Experimental
Intervention type:
Drug
Intervention name:
Salovum
Description:
Active drug
Arm group label:
Experimental
Intervention type:
Drug
Intervention name:
Placebo
Description:
Placebo drugs
Arm group label:
Placebo Comparator
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
General Hospital of Eskilstuna
Address:
City:
Eskilstuna
Zip:
631 88
Country:
Sweden
Status:
Recruiting
Contact:
Last name:
Andreas Nearchou, MD
Email:
andreas.nearchou@regionsormland.se
Facility:
Name:
General Hospital of Falun
Address:
City:
Falun
Zip:
791 82
Country:
Sweden
Status:
Recruiting
Contact:
Last name:
Greger Nilsson, MD, PhD
Email:
greger.nilsson@igp.uu.se
Facility:
Name:
General Hospital of Gävle
Address:
City:
Gävle
Zip:
801 87
Country:
Sweden
Status:
Not yet recruiting
Contact:
Last name:
Olga Del Val Muñoz, MD
Email:
olga.del.val.munoz@regiongavleborg.se
Facility:
Name:
General Hospital
Address:
City:
Sundsvall
Zip:
856 43
Country:
Sweden
Status:
Not yet recruiting
Contact:
Last name:
Anna-Karin Wennstig, MD, PhD
Email:
anna-karin.wennstig@rvn.se
Facility:
Name:
Uppsala University Hospital
Address:
City:
Uppsala
Zip:
751 85
Country:
Sweden
Status:
Recruiting
Contact:
Last name:
Henrik Lindman, MD, PhD
Email:
henrik.lindman@akademiska.se
Facility:
Name:
General Hospital Västerås
Address:
City:
Västerås
Zip:
721 89
Country:
Sweden
Status:
Recruiting
Contact:
Last name:
Cecilia Nilsson, MD, PhD
Email:
Cecilia.nilsson@regionvastmanland.se
Facility:
Name:
University Hospital Örebro
Address:
City:
Örebro
Zip:
701 85
Country:
Sweden
Status:
Recruiting
Contact:
Last name:
Antonis Valachis, MD, PhD
Email:
antonios.valachis@oru.se
Start date:
June 7, 2023
Completion date:
March 31, 2025
Lead sponsor:
Agency:
Henrik Lindman
Agency class:
Other
Source:
Uppsala University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06152471
