Preventing diarrhea in early breast cancer patients taking abemaciclib
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
This study is testing if two products, Salovum™ and SPC-flakes™, can help prevent diarrhea in early breast cancer patients taking the medication abemaciclib.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Uppsala University Hospital Academic / other |
| Locations | 7 sites (Eskilstuna and 6 other locations) |
| Trial ID | NCT06152471 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of Salovum™ and SPC-flakes™ in preventing diarrhea caused by the cancer medication abemaciclib in patients with early-stage breast cancer. It focuses on patients who are at high risk for gastrointestinal side effects from this treatment, which can significantly affect their quality of life. The trial will compare the proactive use of these interventions against a placebo to determine their efficacy in reducing the incidence of diarrhea during the initial treatment phase. By addressing this common side effect, the study aims to improve treatment adherence and overall patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed luminal breast cancer who are about to start treatment with abemaciclib.
Not a fit: Patients with a history of inflammatory bowel disease or those who have previously been treated with abemaciclib, Salovum, or SPC-flakes may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the quality of life for patients undergoing treatment for early breast cancer by minimizing gastrointestinal side effects.
How similar studies have performed: While there is ongoing research into managing side effects of cancer treatments, this specific combination of Salovum and SPC-flakes for abemaciclib-induced diarrhea is a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Eskilstuna and 6 other locations
- General Hospital of Eskilstuna — Eskilstuna, Sweden (Recruiting)
- General Hospital of Falun — Falun, Sweden (Recruiting)
- General Hospital of Gävle — Gävle, Sweden (Not_yet_recruiting)
- General Hospital — Sundsvall, Sweden (Not_yet_recruiting)
- Uppsala University Hospital — Uppsala, Sweden (Recruiting)
- General Hospital Västerås — Västerås, Sweden (Recruiting)
- University Hospital Örebro — Örebro, Sweden (Recruiting)
Study contacts
- Principal investigator: Henrik Lindman, MD, PhD — Uppsala University Hospital
- Study coordinator: Maria Larsson
- Email: maria.b.larsson@akademiska.se
- Phone: +46 18 611 39 45
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.