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Breast CancerPhase 1/2NCT03518268

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

A Phase 1/2 study testing Vivomixx in people with Breast Cancer and Osteoporosis, Osteopenia, run by Tel-Aviv Sourasky Medical Center.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 35 years and older, women only
Conditions the study is for
Breast Cancer, Osteoporosis, Osteopenia
What is being tested?
Vivomixx
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
No sites listed yet
Study dates
Jan 2019to Jun 2021
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age≥ 35 years
  • Breast cancer stages 1-3 (non metastatic)
  • Under treatment with aromatase inhibitors
  • In menopausal status for ≤10y
  • Estrogen receptor positive tumor
  • CTX ≥300 pg/ml

Who cannot join

  • Distant metastases
  • Additional active primary malignancy
  • Metabolic bone disease (primary hyperparathyroidism, hyperthyroidism, paget, osteomalacia etc)
  • Glucocorticoid treatment (chronic or high dose >7.5 mg in the last three months)
  • Bisphosphonate treatment for more than 3 months in the last 2 years
  • Bone densitometry (DXA) T-Score <-2 unless not a candidate for antiresorptive therapy (unwilling/unable to take treatment)
  • Lactose intolerant subjects

Trial locations and contacts

No sites are listed yet.

Sigal Shaklai, M.D, Ph.D contact

+972-3-6973732

Sigal.shaklai@gmail.com

Vanessa Rouach, M.D contact

+972-3-6973732

vanessar@tlvmc.gov.il

About this study

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

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.

Read the 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.

Being tested
Vivomixx, Placebo
Keywords
probiotics, aromatase inhibitors, bone mass, postmenopausal
Medical subject headings
Breast Neoplasms, Osteoporosis, Bone Diseases, Metabolic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VivomixxDrug

    The intervention consists of 2 sachets a day containing the probiotic Vivomixx, for 6 months

  • PlaceboDrug

    The intervention consists of 2 sachets a day of placebo, for 6 months

Study groups in NCT03518268
Study groupRoleWhat they receive
Dietary supplement VivomixxActive comparatorVivomixx 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
Receives: Drug: Vivomixx
PlaceboPlacebo comparatorThe placebo sachets contain the inactive ingredients maltose and silicon dioxides
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Collagen type 1 cross-linked C-telopeptide (CTX)

    Change in percent in CTX in serum compared to placebo

    Measured: 3-6 months

  2. Serum type 1 procollagen (N-terminal) P1NP

    Change in percent in serum in P1NP compared to placebo

    Measured: 3-6 months

Secondary outcomes (6)

  1. Alkaline phosphatase/ bone specific alkaline phosphatase

    Change in percent in alkaline phosphatase/ bone specific alkaline phosphatase in serum compared to placebo

    Measured: 3-6 months

  2. Osteocalcin

    Change in percent in osteocalcin in serum compared to placebo

    Measured: 3-6 months

  3. Sclerostin

    Change in percent in sclerostin in serum compared to placebo

    Measured: 3-6 months

  4. Tumor-necrosis factor-alpha

    Change in percent in tumor-necrosis factor-alpha in serum compared to placebo

    Measured: 3-6 months

  5. Interleukin-17

    Change in percent in interleukin-17 in serum compared to placebo

    Measured: 3-6 months

  6. Receptor activator of nuclear factor kappa B ligand (RANK-ligand)

    Change in percent in RANK-ligand in serum compared to placebo

    Measured: 3-6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2018
  2. Study startJan 2019 (estimated)
  3. Primary completionApr 2021 (estimated)
  4. Study completionJun 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03518268
Sponsor's protocol ID
0124-18-TLV
Status last verified
Jan 2019
First submitted
25 Apr 2018
Last updated
17 Jan 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Vivomixx in people with Breast Cancer and Osteoporosis, Osteopenia, run by Tel-Aviv Sourasky Medical Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sigal Shaklai, M.D, Ph.D (+972-3-6973732, Sigal.shaklai@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Collagen type 1 cross-linked C-telopeptide (CTX) (time frame: 3-6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03518268.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2019.

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