Vivomixx for Prevention of Bone Loss in Women With Breast Cancer Treated With an Aromatase Inhibitor

• Status: Unknown status
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

This study evaluates the efficacy of the probiotic food supplement Vivomixx in the prevention of bone loss occurring in post menopausal women with breast cancer treated with an aromatase inhibitor. Half of the participants will receive Vivomixx while the other half will receive a placebo. The primary endpoint is to assess changes of bone turnover markers during the period of 6 months.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tel-Aviv Sourasky Medical Center
• Collaborator: Perrigo Company
• Treatments: Aromatase Inhibitors

Criteria

Inclusion criteria

1. Age≥ 35 years

2. Breast cancer stages 1-3 (non metastatic)

3. Under treatment with aromatase inhibitors

4. In menopausal status for ≤10y

5. Estrogen receptor positive tumor

6. CTX ≥300 pg/ml

Exclusion criteria

1. Distant metastases

2. Additional active primary malignancy

3. Metabolic bone disease (primary hyperparathyroidism, hyperthyroidism, paget, osteomalacia etc)

4. Glucocorticoid treatment (chronic or high dose >7.5 mg in the last three months)

5. Bisphosphonate treatment for more than 3 months in the last 2 years

6. Bone densitometry (DXA) T-Score <-2 unless not a candidate for antiresorptive therapy (unwilling/unable to take treatment)

7. Lactose intolerant subjects