Debra L Barton1, Lynne T Shuster2, Travis Dockter3, Pamela J Atherton3, Jacqueline Thielen2, Stephen N Birrell4, Richa Sood2, Patricia Griffin5, Shelby A Terstriep6, Bassam Mattar7, Jacqueline M Lafky2, Charles L Loprinzi2. 1. University of Michigan School of Nursing, 400 N. Ingalls, Room 4304, Ann Arbor, MI, 48109-5482, USA. debbartn@med.umich.edu. 2. Mayo Clinic, Rochester, MN, USA. 3. Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA. 4. Dame Roma Mitchell Laboratories, Department of Medicine, University of Adelaide, Adelaide, SA, 5005, Australia. 5. Southeast Clinical Oncology Research (SCOR) Consortium NCORP, Spartanburg Medical Center, Spartanburg, SC, USA. 6. Sanford NCI Community Oncology Research Program of the North Central Plains, Sanford Roger Maris Cancer Center, Fargo, ND, USA. 7. Wichita NCI Community Oncology Research Program, Cancer Center of Kansas, Wichita, KS, USA.
Abstract
BACKGROUND:Dehydroepiandrosterone (DHEA) is helpful for treating vaginal symptoms. This secondary analysis evaluated the impact of vaginal DHEA on hormone concentrations, bone turnover, and vaginal cytology in women with a cancer history. METHODS:Postmenopausal women, diagnosed with breast or gynecologic cancer, were eligible if they reported at least moderate vaginal symptoms. Participants could be on tamoxifen or aromatase inhibitors (AIs). Women were randomized to 3.25 versus 6.5 mg/day of DHEA versus a plain moisturizer (PM) control. Sex steroid hormone levels, biomarkers of bone formation, vaginal pH, and maturation index were collected at baseline and 12 weeks. Analysis included independent t tests and Wilcoxon rank tests, comparing each DHEA arm with the control. RESULTS:Three hundred forty-five women contributed evaluable blood and 46 contributed evaluable cytology and pH values. Circulating DHEA-S and testosterone levels were significantly increased in those on vaginal DHEA in a dose-dependent manner compared to PM. Estradiol was significantly increased in those on 6.5 mg/day DHEA but not in those on 3.25 mg/day DHEA (p < 0.05 and p = 0.05, respectively), and not in those on AIs. Biomarkers of bone formation were unchanged in all arms. Maturation of vaginal cells was 100% (3.25 mg/day), 86% (6.5 mg/day), and 64% (PM); pH decreased more in DHEA arms. CONCLUSION:DHEA resulted in increased hormone concentrations, though still in the lowest half or quartile of the postmenopausal range, and provided more favorable effects on vaginal cytology, compared to PM. Estrogen concentrations in women on AIs were not changed. Further research on the benefit of vaginal DHEA is warranted in hormone-dependent cancers.
RCT Entities:
BACKGROUND:Dehydroepiandrosterone (DHEA) is helpful for treating vaginal symptoms. This secondary analysis evaluated the impact of vaginal DHEA on hormone concentrations, bone turnover, and vaginal cytology in women with a cancer history. METHODS: Postmenopausal women, diagnosed with breast or gynecologic cancer, were eligible if they reported at least moderate vaginal symptoms. Participants could be on tamoxifen or aromatase inhibitors (AIs). Women were randomized to 3.25 versus 6.5 mg/day of DHEA versus a plain moisturizer (PM) control. Sex steroid hormone levels, biomarkers of bone formation, vaginal pH, and maturation index were collected at baseline and 12 weeks. Analysis included independent t tests and Wilcoxon rank tests, comparing each DHEA arm with the control. RESULTS: Three hundred forty-five women contributed evaluable blood and 46 contributed evaluable cytology and pH values. Circulating DHEA-S and testosterone levels were significantly increased in those on vaginal DHEA in a dose-dependent manner compared to PM. Estradiol was significantly increased in those on 6.5 mg/day DHEA but not in those on 3.25 mg/day DHEA (p < 0.05 and p = 0.05, respectively), and not in those on AIs. Biomarkers of bone formation were unchanged in all arms. Maturation of vaginal cells was 100% (3.25 mg/day), 86% (6.5 mg/day), and 64% (PM); pH decreased more in DHEA arms. CONCLUSION:DHEA resulted in increased hormone concentrations, though still in the lowest half or quartile of the postmenopausal range, and provided more favorable effects on vaginal cytology, compared to PM. Estrogen concentrations in women on AIs were not changed. Further research on the benefit of vaginal DHEA is warranted in hormone-dependent cancers.
Authors: Fernand Labrie; Leonard Derogatis; David F Archer; William Koltun; Andrée Vachon; Douglas Young; Louise Frenette; David Portman; Marlene Montesino; Isabelle Côté; Julie Parent; Lyne Lavoie; Adam Beauregard; Céline Martel; Mario Vaillancourt; John Balser; Érick Moyneur Journal: J Sex Med Date: 2015-11-23 Impact factor: 3.802
Authors: Tomasz Osmałek; Anna Froelich; Barbara Jadach; Adam Tatarek; Piotr Gadziński; Aleksandra Falana; Kinga Gralińska; Michał Ekert; Vinam Puri; Joanna Wrotyńska-Barczyńska; Bozena Michniak-Kohn Journal: Pharmaceutics Date: 2021-06-15 Impact factor: 6.321
Authors: Elizabeth Cathcart-Rake; Paul Novotny; Roberto Leon-Ferre; Jennifer Le-Rademacher; Elizabeth M Storrick; Araba A Adjei; Shelby Terstriep; Rebecca Glaser; Armando Giuliano; William R Mitchell; Seth Page; Colleen Austin; Richard L Deming; Margaret A Ferreira; Jacqueline M Lafky; Stephen N Birrell; Charles L Loprinzi Journal: Support Care Cancer Date: 2020-05-06 Impact factor: 3.359