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

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ClinicalTrials.gov Identifier: NCT03518268
Recruitment Status : Unknown
Verified January 2019 by michal roll, Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : May 8, 2018
Last Update Posted : January 17, 2019
Sponsor:
Collaborator:
Perrigo Company
Information provided by (Responsible Party):
michal roll, Tel-Aviv Sourasky Medical Center

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Osteoporosis, Osteopenia Drug: Vivomixx Drug: Placebo Phase 1 Phase 2

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Dietary supplement Vivomixx
Vivomixx sachets contains a mixture of 450 billion viable lyophilized bacteria from 8 strains: Lactobacillus paracasei DSM 24733, Lactobacillus plantarum DSM 24730, Lactobacillus acidophilus DSM 24735, Lactobacillus delbrueckii subspecies bulgaricus DSM 24734, Bifidobacterium longum DSM 3 24736, Bifidobacterium infantis DSM 24737, Bifidobacterium breve DSM 24732, and Streptococcus thermophilus DSM 24731
 Drug: Vivomixx
The intervention consists of 2 sachets a day containing the probiotic Vivomixx, for 6 months
Placebo Comparator: Placebo
The placebo sachets contain the inactive ingredients maltose and silicon dioxides
 Drug: Placebo
The intervention consists of 2 sachets a day of placebo, for 6 months


Outcome Measures
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Primary Outcome Measures :
  1. Collagen type 1 cross-linked C-telopeptide (CTX) [ Time Frame: 3-6 months ]
    Change in percent in CTX in serum compared to placebo

  2. Serum type 1 procollagen (N-terminal) P1NP [ Time Frame: 3-6 months ]
    Change in percent in serum in P1NP compared to placebo


Secondary Outcome Measures :
  1. Alkaline phosphatase/ bone specific alkaline phosphatase [ Time Frame: 3-6 months ]
    Change in percent in alkaline phosphatase/ bone specific alkaline phosphatase in serum compared to placebo

  2. Osteocalcin [ Time Frame: 3-6 months ]
    Change in percent in osteocalcin in serum compared to placebo

  3. Sclerostin [ Time Frame: 3-6 months ]
    Change in percent in sclerostin in serum compared to placebo

  4. Tumor-necrosis factor-alpha [ Time Frame: 3-6 months ]
    Change in percent in tumor-necrosis factor-alpha in serum compared to placebo

  5. Interleukin-17 [ Time Frame: 3-6 months ]
    Change in percent in interleukin-17 in serum compared to placebo

  6. Receptor activator of nuclear factor kappa B ligand (RANK-ligand) [ Time Frame: 3-6 months ]
    Change in percent in RANK-ligand in serum compared to placebo


Eligibility Criteria
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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03518268


Contacts
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Contact: Sigal Shaklai, M.D, Ph.D +972-3-6973732 Sigal.shaklai@gmail.com
Contact: Vanessa Rouach, M.D +972-3-6973732 vanessar@tlvmc.gov.il

Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Perrigo Company
Investigators
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Study Director: Naftali Stern, M.D Tel-Aviv Sourasky Medical Center
More Information
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Responsible Party: michal roll, Deputy Director General for R&D, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT03518268    
Other Study ID Numbers: 0124-18-TLV
First Posted: May 8, 2018    Key Record Dates
Last Update Posted: January 17, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by michal roll, Tel-Aviv Sourasky Medical Center:
probiotics
aromatase inhibitors
bone mass
postmenopausal
Additional relevant MeSH terms:
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Breast Neoplasms
Osteoporosis
Bone Diseases, Metabolic
Neoplasms by Site
Neoplasms
 Breast Diseases
Skin Diseases
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases