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

Breast Cancer Clinical Trial

Official title:

The Efficacy of the Probiotic Supplement Vivomixx on Prevention of Bone Loss in Early Menopausal Women With Breast Cancer Treated With an Aromatase Inhibitor

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03518268
• Other study ID #: 0124-18-TLV
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: January 2019
• Est. completion date: June 2021

Study information

• Verified date: January 2019
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Sigal Shaklai, M.D, Ph.D
• Phone: +972-3-6973732
• Email: Sigal.shaklai[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Aromatase inhibitors function to reduce estrogen levels. They are considered first-line treatment for postmenopausal women with estrogen receptor-positive breast cancer. Estrogen depletion leads to significant loss of bone mineral density and an increased fracture risk. One contributing mechanism to "estrogen deficiency associated bone loss" is the increase in systemic and local gut inflammatory responses upon estrogen deficiency. Probiotics have been shown to decrease inflammatory cytokine formation in both the systemic circulation and gut.

Vivomixx is a high potency probiotic medical food designated for the dietary management of inflammatory gut conditions in adults and children and is currently being studied in clinical trials in a wide variety of inflammatory conditions such as asthma and diabetes. In preclinical studies Vivomixx has been shown to protect from estrogen deficient bone loss.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: June 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Breast Cancer
• Breast Neoplasms
• Osteoporosis
• Osteoporosis, Osteopenia

Intervention

Drug:
• Vivomixx
The intervention consists of 2 sachets a day containing the probiotic Vivomixx, for 6 months
• Placebo
The intervention consists of 2 sachets a day of placebo, for 6 months

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center	Perrigo Company

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collagen type 1 cross-linked C-telopeptide (CTX)	Change in percent in CTX in serum compared to placebo	3-6 months
Primary	Serum type 1 procollagen (N-terminal) P1NP	Change in percent in serum in P1NP compared to placebo	3-6 months
Secondary	Alkaline phosphatase/ bone specific alkaline phosphatase	Change in percent in alkaline phosphatase/ bone specific alkaline phosphatase in serum compared to placebo	3-6 months
Secondary	Osteocalcin	Change in percent in osteocalcin in serum compared to placebo	3-6 months
Secondary	Sclerostin	Change in percent in sclerostin in serum compared to placebo	3-6 months
Secondary	Tumor-necrosis factor-alpha	Change in percent in tumor-necrosis factor-alpha in serum compared to placebo	3-6 months
Secondary	Interleukin-17	Change in percent in interleukin-17 in serum compared to placebo	3-6 months
Secondary	Receptor activator of nuclear factor kappa B ligand (RANK-ligand)	Change in percent in RANK-ligand in serum compared to placebo	3-6 months