A Study of Vulvovaginal Symptoms in Premenopausal Stage 0-III Breast Cancer Patients Treated on Aromatase Inhibitors and Ovarian Suppression
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 18-010367
Sponsor Protocol Number: 18-010367
About this study
The purpose of this study is to evaluate the change of vulvovaginal symptoms score from baseline to 6 months in premenopausal women with stage 0-III breast cancer treating with ovarian suppression in combination with aromatase inhibitors.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Age ≥ 18 years.
- Histological confirmation of adenocarcinoma of the breast stage 0-III.
- Evidence of hormone sensitivity with estrogen receptor (ER) and/or progesterone receptor (PR) positive ≥ 1%) of primary tumor tissue.
- Premenopausal either by continuation of menstrual period or estradiol level ≥ 10 pg/ml.
- Will be starting on ovarian suppression in combination with aromatase inhibitor (letrozole, anastrozole, or exemestane).
- ECOG Performance Status (PS) ≤ 3.
- Ability to complete questionnaire(s) by themselves or with assistance.
- Provide written informed consent.
- Willing to return to enrolling institution for follow-up.
Exclusion Criteria
- Self-report of vaginal itching, dryness, or dyspareunia at baseline.
- Previous history of pelvic reconstruction surgery.
- Co-morbid systemic illnesses or oproper assessment of the treatment.
- Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy.
- NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Brenda Ernst, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available