A Phase 3 interventional study of SPC-flakes and Salovum in Early-stage Breast Cancer, Diarrhea and Adverse Drug Event, sponsored by Henrik Lindman. Status unknown at 7 sites in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-30.
Sponsored by Henrik Lindman · Phase 3, Interventional, and Treatment
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.
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.
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's planned enrollment of 100 is above the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Henrik Lindman is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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 · Drug: Salovum
Placebo, identical to investigational product but without antisecretory factor.
Drug: Placebo
Aktive drug
Active drug
Placebo drugs
Occurrence of Abemaciclib induced diarrhea - STIDAT
● Occurrence of any-grade (mild, moderate, severe) diarrhea according to the Systemic Treatment-Induced Diarrhea Assessment Tool (STIDAT; patient-reported outcome).
Time frame: Three months
Occurrence of abemaciclib induced diarrhea - CTCAE
Occurrence of any-grade diarrhea according to CTCAE v. 5.0
Time frame: Three months
QoL using FACT-B
The tool is FACT-B
Time frame: Three months
QoL using FACT-GP5
The tool is FACT-GP5
Time frame: Three months
QoL using FACIT-D
The tool is FACIT-D
Time frame: Three months
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] besides diarrhea.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, besides diarrhea.
Time frame: Three months
Rate of patients that stop or interrupt treatment with investigational products
Rate of patients that stop or interrupt treatment with Salovum and SPC-flakes/placebo during planned study time.
Time frame: Three months
Rate of patients that stop or interrupt treatment with abemaciclib
Rate of patients that stop or interrupt treatment with abemaciclib during the planned treatment time of two years.
Time frame: Two years
Sick leave
Sick leave duration
Time frame: Two years
Breast cancer recurrence
Breast cancer recurrence
Time frame: Two years
Started Jun 2023 (actual). Primary completion is estimated for Oct 2024, 16 months after the start.
Of 293 non-industry phase 3 interventional studies under Breast Neoplasms, half reached primary completion within 80 months of starting (the median), counting those still running; a quarter within 50 and three quarters within 125. This study's planned 16 months is below that.
Counting every sponsor, half of 540 studies reached it within 58 months; a quarter within 34 and three quarters within 93.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Antisecretory Factor-enriched Egg Yolk Powder Supplement