Systemic and local effects of vaginal dehydroepiandrosterone (DHEA): NCCTG N10C1 (Alliance)

Debra L. Barton, Lynne T. Shuster, Travis Dockter, Pamela J. Atherton, Jacqueline Thielen, Stephen N. Birrell, Richa Sood, Patricia Griffin, Shelby A. Terstriep, Bassam Mattar, Jacqueline M. Lafky, Charles Lawrence Loprinzi

Research output: Contribution to journalArticle

3 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)1-9
Number of pages9
JournalSupportive Care in Cancer
DOIs
StateAccepted/In press - Nov 21 2017

Fingerprint

Dehydroepiandrosterone
Aromatase Inhibitors
Cell Biology
Arm
Hormones
Osteogenesis
Biomarkers
Neoplasms
Bone Remodeling
Gonadal Steroid Hormones
Tamoxifen
Nonparametric Statistics
Testosterone
Estradiol
Estrogens
Breast

Keywords

  • Postmenopause
  • Vaginal dehydroepiandrosterone
  • Vaginal symptoms

ASJC Scopus subject areas

  • Oncology

Cite this

Barton, D. L., Shuster, L. T., Dockter, T., Atherton, P. J., Thielen, J., Birrell, S. N., ... Loprinzi, C. L. (Accepted/In press). Systemic and local effects of vaginal dehydroepiandrosterone (DHEA): NCCTG N10C1 (Alliance). Supportive Care in Cancer, 1-9. https://doi.org/10.1007/s00520-017-3960-9

Systemic and local effects of vaginal dehydroepiandrosterone (DHEA) : NCCTG N10C1 (Alliance). / Barton, Debra L.; Shuster, Lynne T.; Dockter, Travis; Atherton, Pamela J.; Thielen, Jacqueline; Birrell, Stephen N.; Sood, Richa; Griffin, Patricia; Terstriep, Shelby A.; Mattar, Bassam; Lafky, Jacqueline M.; Loprinzi, Charles Lawrence.

In: Supportive Care in Cancer, 21.11.2017, p. 1-9.

Research output: Contribution to journalArticle

Barton, DL, Shuster, LT, Dockter, T, Atherton, PJ, Thielen, J, Birrell, SN, Sood, R, Griffin, P, Terstriep, SA, Mattar, B, Lafky, JM & Loprinzi, CL 2017, 'Systemic and local effects of vaginal dehydroepiandrosterone (DHEA): NCCTG N10C1 (Alliance)', Supportive Care in Cancer, pp. 1-9. https://doi.org/10.1007/s00520-017-3960-9
Barton, Debra L. ; Shuster, Lynne T. ; Dockter, Travis ; Atherton, Pamela J. ; Thielen, Jacqueline ; Birrell, Stephen N. ; Sood, Richa ; Griffin, Patricia ; Terstriep, Shelby A. ; Mattar, Bassam ; Lafky, Jacqueline M. ; Loprinzi, Charles Lawrence. / Systemic and local effects of vaginal dehydroepiandrosterone (DHEA) : NCCTG N10C1 (Alliance). In: Supportive Care in Cancer. 2017 ; pp. 1-9.
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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.",
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AU - Shuster, Lynne T.

AU - Dockter, Travis

AU - Atherton, Pamela J.

AU - Thielen, Jacqueline

AU - Birrell, Stephen N.

AU - Sood, Richa

AU - Griffin, Patricia

AU - Terstriep, Shelby A.

AU - Mattar, Bassam

AU - Lafky, Jacqueline M.

AU - Loprinzi, Charles Lawrence

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N2 - 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.

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