Evaluating the efficacy of vaginal dehydroepiandosterone for vaginal symptoms in postmenopausal cancer survivors

NCCTG N10C1 (Alliance)

Debra L. Barton, Jeff A Sloan, Lynne T. Shuster, Paula Gill, Patricia Griffin, Kathleen Flynn, Shelby A. Terstriep, Fauzia N. Rana, Travis Dockter, Pamela J. Atherton, Michaela Tsai, Keren Sturtz, Jacqueline M. Lafky, Mike Riepl, Jacqueline Thielen, Charles Lawrence Loprinzi

Research output: Contribution to journalArticle

10 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)1-8
Number of pages8
JournalSupportive Care in Cancer
DOIs
StateAccepted/In press - Sep 18 2017

Fingerprint

Dehydroepiandrosterone
Survivors
Reproductive Health
Neoplasms
Dyspareunia
Arm
Estrogens
Breast
Randomized Controlled Trials

Keywords

  • DHEA
  • Sexual health
  • Vaginal symptoms
  • Women

ASJC Scopus subject areas

  • Oncology

Cite this

Evaluating the efficacy of vaginal dehydroepiandosterone for vaginal symptoms in postmenopausal cancer survivors : NCCTG N10C1 (Alliance). / Barton, Debra L.; Sloan, Jeff A; Shuster, Lynne T.; Gill, Paula; Griffin, Patricia; Flynn, Kathleen; Terstriep, Shelby A.; Rana, Fauzia N.; Dockter, Travis; Atherton, Pamela J.; Tsai, Michaela; Sturtz, Keren; Lafky, Jacqueline M.; Riepl, Mike; Thielen, Jacqueline; Loprinzi, Charles Lawrence.

In: Supportive Care in Cancer, 18.09.2017, p. 1-8.

Research output: Contribution to journalArticle

Barton, DL, Sloan, JA, Shuster, LT, Gill, P, Griffin, P, Flynn, K, Terstriep, SA, Rana, FN, Dockter, T, Atherton, PJ, Tsai, M, Sturtz, K, Lafky, JM, Riepl, M, Thielen, J & Loprinzi, CL 2017, 'Evaluating the efficacy of vaginal dehydroepiandosterone for vaginal symptoms in postmenopausal cancer survivors: NCCTG N10C1 (Alliance)', Supportive Care in Cancer, pp. 1-8. https://doi.org/10.1007/s00520-017-3878-2
Barton, Debra L. ; Sloan, Jeff A ; Shuster, Lynne T. ; Gill, Paula ; Griffin, Patricia ; Flynn, Kathleen ; Terstriep, Shelby A. ; Rana, Fauzia N. ; Dockter, Travis ; Atherton, Pamela J. ; Tsai, Michaela ; Sturtz, Keren ; Lafky, Jacqueline M. ; Riepl, Mike ; Thielen, Jacqueline ; Loprinzi, Charles Lawrence. / Evaluating the efficacy of vaginal dehydroepiandosterone for vaginal symptoms in postmenopausal cancer survivors : NCCTG N10C1 (Alliance). In: Supportive Care in Cancer. 2017 ; pp. 1-8.
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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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AU - Shuster, Lynne T.

AU - Gill, Paula

AU - Griffin, Patricia

AU - Flynn, Kathleen

AU - Terstriep, Shelby A.

AU - Rana, Fauzia N.

AU - Dockter, Travis

AU - Atherton, Pamela J.

AU - Tsai, Michaela

AU - Sturtz, Keren

AU - Lafky, Jacqueline M.

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AU - Thielen, Jacqueline

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N2 - 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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