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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 : 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

Tracking Information
First Submitted Date  ICMJE April 25, 2018
First Posted Date  ICMJE May 8, 2018
Last Update Posted Date January 17, 2019
Estimated Study Start Date  ICMJE January 2019
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2018)
  • Collagen type 1 cross-linked C-telopeptide (CTX) [ Time Frame: 3-6 months ]
    Change in percent in CTX in serum compared to placebo
  • Serum type 1 procollagen (N-terminal) P1NP [ Time Frame: 3-6 months ]
    Change in percent in serum in P1NP compared to placebo
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03518268 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2018)
  • 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
  • Osteocalcin [ Time Frame: 3-6 months ]
    Change in percent in osteocalcin in serum compared to placebo
  • Sclerostin [ Time Frame: 3-6 months ]
    Change in percent in sclerostin in serum compared to placebo
  • Tumor-necrosis factor-alpha [ Time Frame: 3-6 months ]
    Change in percent in tumor-necrosis factor-alpha in serum compared to placebo
  • Interleukin-17 [ Time Frame: 3-6 months ]
    Change in percent in interleukin-17 in serum compared to placebo
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vivomixx for Prevention of Bone Loss in Women With Breast Cancer Treated With an Aromatase Inhibitor
Official Title  ICMJE The Efficacy of the Probiotic Supplement Vivomixx on Prevention of Bone Loss in Early Menopausal Women With Breast Cancer Treated With an Aromatase Inhibitor
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Breast Cancer
  • Osteoporosis, Osteopenia
Intervention  ICMJE
  • Drug: Vivomixx
    The intervention consists of 2 sachets a day containing the probiotic Vivomixx, for 6 months
  • Drug: Placebo
    The intervention consists of 2 sachets a day of placebo, for 6 months
Study Arms  ICMJE
  • 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
    Intervention: Drug: Vivomixx
  • Placebo Comparator: Placebo
    The placebo sachets contain the inactive ingredients maltose and silicon dioxides
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 25, 2018)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 35 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03518268
Other Study ID Numbers  ICMJE 0124-18-TLV
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party michal roll, Tel-Aviv Sourasky Medical Center
Study Sponsor  ICMJE Tel-Aviv Sourasky Medical Center
Collaborators  ICMJE Perrigo Company
Investigators  ICMJE
Study Director: Naftali Stern, M.D Tel-Aviv Sourasky Medical Center
PRS Account Tel-Aviv Sourasky Medical Center
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP