Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03518268
Other study ID # 0124-18-TLV
Secondary ID
Status Not yet recruiting
Phase Phase 1/Phase 2
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT04681911 - Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer Phase 2
Terminated NCT04066790 - Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer Phase 2
Completed NCT04890327 - Web-based Family History Tool N/A
Completed NCT03591848 - Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility N/A
Recruiting NCT03954197 - Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients N/A
Terminated NCT02202746 - A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer Phase 2
Active, not recruiting NCT01472094 - The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
Completed NCT06049446 - Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
Withdrawn NCT06057636 - Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study N/A
Recruiting NCT05560334 - A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations Phase 2
Active, not recruiting NCT05501769 - ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer Phase 1
Recruiting NCT04631835 - Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer Phase 1
Completed NCT04307407 - Exercise in Breast Cancer Survivors N/A
Recruiting NCT03544762 - Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation Phase 3
Terminated NCT02482389 - Study of Preoperative Boost Radiotherapy N/A
Enrolling by invitation NCT00068003 - Harvesting Cells for Experimental Cancer Treatments
Completed NCT00226967 - Stress, Diurnal Cortisol, and Breast Cancer Survival
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT06019325 - Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy N/A
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2