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Evaluating the efficacy of vaginal dehydroepiandosterone for vaginal symptoms in postmenopausal cancer survivors: NCCTG N10C1 (Alliance)

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Abstract

Background

Women with estrogen deficiencies can suffer from vaginal symptoms that negatively impact sexual health. This study evaluated vaginal dehydroepiandrosterone (DHEA) for alleviation of vaginal symptoms.

Methods

This three-arm randomized, controlled trial evaluated DHEA 3.25 mg and DHEA 6.5 mg, each compared to a plain moisturizer (PM) over 12 weeks, to improve the severity of vaginal dryness or dyspareunia, measured with an ordinal scale, and overall sexual health using the Female Sexual Function Index (FSFI). Postmenopausal women with a history of breast or gynecologic cancer who had completed primary treatment, had no evidence of disease, and reported at least moderate vaginal symptoms were eligible. The mean change from baseline to week 12 in the severity of vaginal dryness or dyspareunia for each DHEA dose was compared to PM and analyzed by two independent t tests using a Bonferroni correction.

Results

Four hundred sixty-four women were randomized. All arms reported improvement in either dryness or dyspareunia. Neither DHEA dose was statistically significantly different from PM at 12 weeks (6.25 mg, p = .08; 3.25 mg, p = 0.48), although a significant difference at 8 weeks for 6.5 mg DHEA was observed (p = 0.005). Women on the 6.5 mg arm of DHEA reported significantly better sexual health on the FSFI (p < 0.001). There were no significant differences in provider-graded toxicities and few significant differences in self-reported side effects.

Conclusion

PM and DHEA improved vaginal symptoms at 12 weeks. However, vaginal DHEA, 6.5 mg, significantly improved sexual health. Vaginal DHEA warrants further investigation in women with a history of cancer.

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Funding

This work was supported by the National Cancer Institute of the National Institutes of Health [grant number UG1CA189823, to the Alliance for Clinical Trials in Oncology NCORP Grant], and also in part by the Public Health Service [grant numbers 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. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Cancer Institute or the National Institutes of Health.

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Authors and Affiliations

  1. University of Michigan School of Nursing, 400 N. Ingalls, Room 4304, Ann Arbor, MI, 48109-5482, USA

    Debra L. Barton

  2. Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA

    Jeff A. Sloan, Travis Dockter & Pamela J. Atherton

  3. Mayo Clinic, Rochester, MN, USA

    Lynne T. Shuster, Paula Gill, Jacqueline M. Lafky, Jacqueline Thielen & Charles L. Loprinzi

  4. Southeast Clinical Oncology Research (SCOR) Consortium NCORP, Spartanburg Medical Center, Spartanburg, SC, USA

    Patricia Griffin

  5. Michigan Cancer Research Consortium NCORP, Ann Arbor, MI, USA

    Kathleen Flynn

  6. Meritcare Hospital CCOP, Fargo, ND, USA

    Shelby A. Terstriep

  7. Mayo Clinic Florida, Jacksonville, FL, USA

    Fauzia N. Rana

  8. Metro-Minnesota NCORP, St. Louis Park, MN, USA

    Michaela Tsai

  9. Colorado Cancer Research NCORP, Denver, CO, USA

    Keren Sturtz

  10. Gateway Pharmacy North, Bismarck, ND, USA

    Mike Riepl

Authors
  1. Debra L. Barton
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  2. Jeff A. Sloan
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  4. Paula Gill
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  8. Fauzia N. Rana
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  9. Travis Dockter
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  10. Pamela J. Atherton
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  11. Michaela Tsai
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  12. Keren Sturtz
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  13. Jacqueline M. Lafky
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  15. Jacqueline Thielen
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  16. Charles L. Loprinzi
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Corresponding author

Correspondence to Debra L. Barton.

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Conflict of interest

This study was funded by the National Cancer Institute (NCI) and the Breast Cancer Research Foundation (BCRF). However, the work is solely that of the authors and does not represent the views of the NCI or BCRF. None of the authors have a relationship that represents a conflict with either of these funding agencies. The Data and Management Center of the Alliance has full control of the primary data and if there were a question about the data that required inspection, it could be made available.

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Barton, D.L., Sloan, J.A., Shuster, L.T. et al. Evaluating the efficacy of vaginal dehydroepiandosterone for vaginal symptoms in postmenopausal cancer survivors: NCCTG N10C1 (Alliance). Support Care Cancer 26, 643–650 (2018). https://doi.org/10.1007/s00520-017-3878-2

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  • DOI: https://doi.org/10.1007/s00520-017-3878-2

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