Know Cancer

or
forgot password

The Ability of an Orally Administered Preparation of Four Lactobacillus Species to Improve the Quality of the Vaginal Flora of Women With Breast Cancer and Chemotherapy. A Prospective Randomized Placebo-controlled, Double-blind Trial


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

The Ability of an Orally Administered Preparation of Four Lactobacillus Species to Improve the Quality of the Vaginal Flora of Women With Breast Cancer and Chemotherapy. A Prospective Randomized Placebo-controlled, Double-blind Trial


Inclusion Criteria:



Only women with breast cancer and neoadjuvant / adjuvant chemotherapy, at least 4 weeks
postoperative, without vaginal bleeding without abnormal vaginal discharge, Only women
with Nugent scores between 4 and 6

Exclusion Criteria:

Patients with diarrhoea, constipation, vaginal or urinary tract infection requiring
antibacterial treatment and women receiving antibiotic therapy in the previous 4 weeks.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Outcome Measure:

change in Nugent score between baseline and end of treatment (improvement or no improvement)

Outcome Description:

Using Nugent scoring system, from each participant first swab from the vagina will be taken before start of oral probiotic use.(baseline information) Second swab will be taken on the day following the last administration.(information about change in Nugent)

Outcome Time Frame:

day 0, 7 and day 14 of oral probiotic application

Safety Issue:

No

Principal Investigator

Herbert Kiss, MD

Investigator Role:

Study Director

Investigator Affiliation:

Medical University of Vienna, Dept. of Obstetrics and Gynecology

Authority:

Austria: Ethikkommission

Study ID:

MUW EK 1417/2012

NCT ID:

NCT01723592

Start Date:

October 2012

Completion Date:

May 2013

Related Keywords:

  • Breast Cancer
  • chemotherapy
  • vaginal flora
  • Breast Neoplasms

Name

Location