title: A pilot randomized trial to prevent sexual dysfunction in postmenopausal breast cancer survivors starting adjuvant aromatase inhibitor therapy.
abstract: OBJECTIVE
  A randomized pilot trial evaluated the hypothesis that early intervention lessens sexual dysfunction in the first year on aromatase inhibitors. A secondary aim was comparing the efficacy of two vaginal moisturizers.
  
  
  METHODS
  Fifty-seven postmenopausal women with early stage breast cancer starting aromatase inhibitors were randomized to three treatment groups. All received a handout on managing sexual and other side effects. The Usual Care group received no additional therapy. The Active Treatment groups received a 6-month supply of a vaginal moisturizer (hyaluronic acid-based in Active Group-H and prebiotic in Active Group-P) and a vaginal lubricant and dilator, plus access to an educational website and phone coaching. Questionnaires completed at baseline, 6, and 12 months included the Female Sexual Function Index (FSFI), Menopausal Sexual Interest Questionnaire (MSIQ), Female Sexual Distress Scale-Revised (FSDS-R), and a menopausal symptom scale.
  
  
  RESULTS
  Forty-nine women (86%) provided follow-up data. Mean age was 59 and 77% were non-Hispanic Caucasian. Sexual function was impaired at baseline, but remained stable over 12 months for all groups. The combined active treatment group had less dyspareunia (P = 0.07) and sexual distress (P = 0.02) at 6 months than the Usual Care group. At 6 months, the Active-H group improved significantly more than the Active-P group on FSFI total score (P = 0.04).
  
  
  CONCLUSIONS
  Sexual counseling helped women maintain stable sexual function on aromatase inhibitors. Active intervention resulted in better outcomes at 6 months.
  
  
  CONCLUSIONS
  This promising pilot trial suggests a need for more research on preventive counseling to maintain sexual function during aromatase inhibitor treatment.
authors.affiliation: Department of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
authors.forename: Pragati
authors.initials: P
authors.lastname: Advani
authors.affiliation: Department of Clinical Cancer Prevention, University of Texas MD Anderson Cancer Center, Houston, TX, 77030, USA.
authors.forename: Abenaa M
authors.initials: AM
authors.lastname: Brewster
authors.affiliation: Department of Behavioral Science, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
authors.forename: George P
authors.initials: GP
authors.lastname: Baum
authors.affiliation: Department of Behavioral Science, University of Texas MD Anderson Cancer Center, Houston, TX, USA. lschover@gmail.com.
authors.forename: Leslie R
authors.initials: LR
authors.lastname: Schover
mesh_terms: D047072:Aromatase Inhibitors / Q000009:adverse effects*; D001943:Breast Neoplasms / Q000523:psychology / Q000628:therapy*; D005260:Female; D006801:Humans; D008875:Middle Aged; D010865:Pilot Projects; D017698:Postmenopause; D012725:Sexual Behavior / Q000187:drug effects / Q000523:psychology*; D011795:Surveys and Questionnaires; D017741:Survivors / Q000523:psychology*
chemical_list: D047072:Aromatase Inhibitors
keywords: Aromatase inhibitors; Breast cancer; Dyspareunia; Genitourinary atrophy; Prevention; Sexual dysfunction