A pilot randomized trial to prevent sexual dysfunction in postmenopausal breast cancer survivors starting adjuvant aromatase inhibitor therapy
- 597 Downloads
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.
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.
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).
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.
KeywordsBreast cancer Aromatase inhibitors Sexual dysfunction Dyspareunia Prevention Genitourinary atrophy
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.
Compliance with ethical standards
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.
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.
- 1.Early Breast Cancer Trialists’ Collaborative Group (EBCTCG), Dowsett M, Forbes JF, Bradley R, Ingle J, Aihara T, Bliss J, Boccardo F, Coates A, Coombes RC, Cuzick J, Dubsky P, Gnant M, Kaufmann M, Kilburn L, Perrone F, Rea D, Thürlimann B, van de Velde C, Pan H, Peto R, Davies C, Gray R. Aromatase inhibitors versus tamoxifen in early breast cancer; patient-level meta-analysis of the randomised trials. Lancet. 2015; 386:1341–1352.Google Scholar
- 2.Goss PE, Ingle JN, Pritchard KI, Robert NJ, Muss H, Gralow J, Gelmon K, Whelan T, Strasser-Weippl K, Rubin S, Sturtz K, Wolff AC, Winer E, Hudis C, Stopeck A, Beck JT, Kaur JS, Whelan K, Tu D, Parulekar WR. Extending aromatase-inhibitor adjuvant therapy to 10 years. N Eng J Med. 2016.Google Scholar
- 3.Bernhard J, Luo W, Ribi K, Colleoni M, Burstein HJ, Tondini C, Pinotti G, Spazzapan S, Ruhstaller T, Puglisi F, Pavesi L, Parmar V, Regan MM, Pagani O, Fleming GF, Francis PA, Price KN, Coates AS, Gelber RD, Goldhirsch A, Walley BA. Patient-reported outcomes with adjuvant exemestane versus tamoxifen in premenopausal women with early breast cancer undergoing ovarian suppression (TEXT and SOFT): a combined analysis of two phase 3 randomised trials. Lancet Oncol. 2015;16:848–58.CrossRefPubMedPubMedCentralGoogle Scholar
- 4.Burstein HJ, Lacchetti C, Anderson H, Buchholz TA, Davidson NE, Gelmon KE, Giordano SH, Hudis CA, Solky AJ, Stearns V, Winer EP, Griggs JJ. Adjuvant endocrine therapy for women with hormone receptor-positive breast cancer: American Society of Clinical Oncology Clinical Practice Guideline Update on ovarian suppression. J Clin Oncol. 2016;34:1689–701.CrossRefPubMedGoogle Scholar
- 9.Groenvold M. Health-related quality of life in early breast cancer. Dan Med Bull. 2010;57:B4814.Google Scholar
- 13.Carter J, Stabile C, Seidel B, Baser RE, Gunn AR, Chi S, Steed RF, Goldfarb S, Goldfrank DJ. Baseline characteristics and concerns of female cancer patients/survivors seeking treatment at a female sexual medicine program. Support Care Cancer. 2015;23:2255–65.CrossRefPubMedPubMedCentralGoogle Scholar
- 28.Miles T, Johnson N. Vaginal dilator therapy for women receiving pelvic radiotherapy. Cochrane Database Syst Rev. 2014;8:CD007291.Google Scholar
- 36.Committee Opinion No. 659. The use of vaginal estrogen in women with a history of estrogen-dependent breast cancer. Obstet Gynecol. 2016;127:393–396.Google Scholar
- 37.Donders G, Neven P, Moegele M, Lintermans A, Bellen G, Prasauskas V, Grob P, Ortmann O, Buchholz S. Ultra-low-dose estriol and lactobacillus acidophilus vaginal tablets (Gynoflor®) for vaginal atrophy in postmenopausal breast cancer patients on aromatase inhibitors: pharmacokinetic, safety, and efficacy phase I clinical study. Breast Cancer Res Treat. 2014;145:371–9.CrossRefPubMedPubMedCentralGoogle Scholar
- 39.Juraskova I, Jarvis S, Mok K, Peate M, Meiser B, Cheah BC, Mireskandari S, Friedlander M. The acceptability, feasibility, and efficacy (phase l/II study) of the OVERcome (olive oil, vaginal exercise, and moisturizer) intervention to improve dyspareunia and alleviate sexual problems in women with breast cancer. J Sex Med. 2013;20:2549–58.CrossRefGoogle Scholar
- 41.Mocellin S, Pilati P, Briarava M, Nitti D. Breast Cancer Chemoprevention: A Network Meta-Analysis of Randomized Controlled Trials. J Natl Cancer Inst. 2016;108.Google Scholar
- 42.Jennings S, Philip EJ, Nelson C, Schuler T, Starr T, Jandorf L, Temple L, Garcia E, Carter J, DuHamel K. Barriers to recruitment in psycho-oncology: unique challenges in conducting research focusing on sexual health in female survivorship. Psychooncology. 2014;23:1192–5.CrossRefPubMedPubMedCentralGoogle Scholar