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A pilot randomized trial to prevent sexual dysfunction in postmenopausal breast cancer survivors starting adjuvant aromatase inhibitor therapy

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Abstract

Purpose

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.

Implications for Cancer Survivors

This promising pilot trial suggests a need for more research on preventive counseling to maintain sexual function during aromatase inhibitor treatment.

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Acknowledgments

This work was supported by a grant from the University of Texas MD Anderson Cancer Center, Duncan Family Institute for Cancer Prevention and Risk Assessment. Support was provided, in part, by the Patient-Reported Outcomes, Survey, and Population Research (PROSPR) Shared Resource through a Cancer Center Support Grant (CA16672, PI: R. DePinho, MD Anderson Cancer Center), from the National Cancer Institute, National Institutes of Health. Vaginal moisturizer for the study was donated by Fidia Pharma, USA, Inc., and by Laclede, Inc. The authors would like to thank Lisa Fuson, APN, for assistance in recruiting participants.

Author information

Authors and Affiliations

  1. Department of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA

    Pragati Advani

  2. Department of Clinical Cancer Prevention, University of Texas MD Anderson Cancer Center, Houston, TX, 77030, USA

    Abenaa M. Brewster

  3. Department of Behavioral Science, University of Texas MD Anderson Cancer Center, Houston, TX, USA

    George P. Baum & Leslie R. Schover

Authors
  1. Pragati Advani
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  2. Abenaa M. Brewster
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  3. George P. Baum
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  4. Leslie R. Schover
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Corresponding author

Correspondence to Leslie R. Schover.

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Conflict of interest

Pragati Advani, Abenaa Brewster, and George P. Baum declare that they have no conflict of interest. Leslie Schover acknowledges that Fidia Pharma, USA, Inc., and Laclede, Inc., donated vaginal moisturizer for the study. She also holds a financial interest in Will2Love, LLC, a digital health company based in part on the intervention in reference 17.

Ethical approval

All procedures performed in studies involving human participants were performed under an approved protocol and in accordance with the ethical standards of the institutional research committee of the University of Texas MD Anderson Cancer Center and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Additional information

Leslie R. Schover retired from University of Texas MD Anderson Cancer Center, Houston, TX, USA.

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Advani, P., Brewster, A.M., Baum, G.P. et al. A pilot randomized trial to prevent sexual dysfunction in postmenopausal breast cancer survivors starting adjuvant aromatase inhibitor therapy. J Cancer Surviv 11, 477–485 (2017). https://doi.org/10.1007/s11764-017-0606-3

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  • DOI: https://doi.org/10.1007/s11764-017-0606-3

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