Clinical trial · Interventional
Effect of Salovum™ and SPC-Flakes™ on Abemaciclib-induced Gastrointestinal Toxicity in Early Breast Cancer
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
NCT06152471CI-TRIAL-00071868ASF-BCunknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adverse Drug Event | — | UNRESOLVED | — |
| Diarrhea | — | UNRESOLVED | — |
| Early-stage Breast Cancer | Early Stage Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Salovum | Drug | Antisecretory Factor-enriched Egg Yolk Powder Supplement | ALIAS |
| SPC-flakes | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental
- description
- 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
- interventionNames
- Drug: SPC-flakes
- Drug: Salovum
- type
- PLACEBO_COMPARATOR
- label
- Placebo Comparator
- description
- Placebo, identical to investigational product but without antisecretory factor.
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Occurrence of Abemaciclib induced diarrhea - STIDAT
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.