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Supportive Care in Cancer

, Volume 26, Issue 4, pp 1335–1343 | Cite as

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

  • Debra L. BartonEmail author
  • 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 L. Loprinzi
Original Article

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.

Keywords

Vaginal dehydroepiandrosterone Vaginal symptoms Postmenopause 

Notes

Funding

This work was supported by the National Cancer Institute of the National Institutes of Health (grant UG1CA189823, to the Alliance for Clinical Trials in Oncology NCORP Grant) and also in part by the Public Health Service (grants U10CA025224, U10CA035090, U10CA035101, U10CA035103, U10CA035113, U10CA035119, U10CA035267, U10CA035269, U10CA035415, U10CA035431, U10CA035448, U10CA037404, U10CA037417, U10CA052352, U10CA063848, U10CA063849, U10CA180790, UG1CA189863, and UG1CA189971). This work was also supported in part by funds from a grant from the Breast Cancer Research Foundation.

Compliance with ethical standards

Conflict of interest

This study was supported by the National Cancer Institute and the Breast Cancer Research Foundation. None of the authors have any conflicts of interest with either of these two funding agencies. The work is solely that of the authors and does not reflect the views of the funding agencies. The data is under the control of the Statistics and Data Management group of the Alliance and can be produced in support of the analysis described in this paper, if required.

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Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2017

Authors and Affiliations

  • Debra L. Barton
    • 1
    Email author
  • Lynne T. Shuster
    • 2
  • Travis Dockter
    • 3
  • Pamela J. Atherton
    • 3
  • Jacqueline Thielen
    • 2
  • Stephen N. Birrell
    • 4
  • Richa Sood
    • 2
  • Patricia Griffin
    • 5
  • Shelby A. Terstriep
    • 6
  • Bassam Mattar
    • 7
  • Jacqueline M. Lafky
    • 2
  • Charles L. Loprinzi
    • 2
  1. 1.University of Michigan School of NursingAnn ArborUSA
  2. 2.Mayo ClinicRochesterUSA
  3. 3.Alliance Statistics and Data CenterMayo ClinicRochesterUSA
  4. 4.Dame Roma Mitchell Laboratories, Department of MedicineUniversity of AdelaideAdelaideAustralia
  5. 5.Southeast Clinical Oncology Research (SCOR) Consortium NCORPSpartanburg Medical CenterSpartanburgUSA
  6. 6.Sanford NCI Community Oncology Research Program of the North Central PlainsSanford Roger Maris Cancer CenterFargoUSA
  7. 7.Wichita NCI Community Oncology Research ProgramCancer Center of KansasWichitaUSA

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