|Phase III||Biomarker/Laboratory analysis, Supportive care||Closed||18 and over||NCI, Other||CDR0000702003|
NCCTG-N10C1, N10C1, NCT01376349
RATIONALE: Dehydroepiandrosterone (DHEA) may help relieve vaginal symptoms in female cancer survivors.
PURPOSE: This randomized phase III trial studies DHEA to see how well it works compared to placebo in treating postmenopausal cancer survivors with vaginal symptoms.
Further Study Information
- To determine the effectiveness of two doses of daily vaginal prasterone (dehydroepiandrosterone [DHEA]) versus placebo for alleviation of the most bothersome vaginal symptom (vaginal dryness or dyspareunia) over 12 weeks.
- To evaluate any toxicities arising from DHEA in this patient population. (Exploratory)
- To evaluate the impact of vaginal DHEA on negative sexual thoughts, sexual function and urologic symptoms. (Exploratory)
- To explore the role of psychologic (mood, stress), physical (demographics and treatment variables) and situational factors (partner variables and fatigue) as predictors of vaginal dryness and performance outcomes at baseline and at various endpoints throughout the study. (Exploratory)
- To explore the characteristics of vaginal atrophy and the relationship between vaginal atrophy and quality-of-life questionnaire responses and exposure to hormonal therapy (tamoxifen, exemestane, anastrozole, or letrozole). (Exploratory)
- To examine the effects of the use of open-label vaginal DHEA gel over 8 weeks in women completing the placebo gel arm of the randomized trial. (Exploratory)
- To evaluate the impact of vaginal DHEA on maturation index and pH (select institutions). (Correlative)
- To evaluate the impact of vaginal DHEA on sex steroid concentrations (estradiol, free testosterone, estrone, and DHEA-S) and markers of bone turnover (osteocalcin and bone alkaline phosphatase). (Correlative)
- To bank blood products for future studies. (Correlative)
OUTLINE: This is a multicenter study. Patients are stratified according to current tamoxifen therapy (yes vs no), concurrent aromatase inhibitor (anastrozole/letrozole vs exemestane vs none), hysterectomy (yes vs no), and cigarette smoking (current vs past vs never). Patients are randomized to 1 of 3 treatment arms.
- Arm I: Participants apply a low dose of vaginal prasterone (dehydroepiandrosterone [DHEA]) gel once daily (QD), at bed time, for 12 weeks.
- Arm II: Participants apply a high dose of vaginal DHEA gel QD, at bed time, for 12 weeks.
- Arm III: Participants apply a vaginal placebo gel QD, at bed time, for 12 weeks.
- Optional Continuation Phase (for placebo arm only): Participants apply a high dose of vaginal DHEA gel QD, at bed time, for 12 weeks.
Participants undergo blood sample collection at baseline and during weeks 11-12 for estradiol, free testosterone, estrone, DHEA-sulfate, osteocalcin, and bone alkaline phosphatase analysis. Some participants also undergo vaginal cells collection and vaginal pH tests.
Participants may complete the Profile of Mood States (POMS), the Perceived Stress Scale (PSS), the Fatigue: Vitality subscale of the SF-36, the Vaginal Symptom Quality Questionnaire, the DHEA Side Effect Questionnaire, the Female Sexual Function Index (FSFI), the Sexually Related Intrusive Thoughts - ITS, Impact of Treatment Scale, the Urogenital Atrophy Questionnaire, and the Subject Global Impression of Change at baseline and periodically during study.
- Postmenopausal women with a history of breast or gynecologic cancer (currently no evidence of disease)
- Postmenopausal status determined by the following criteria:
- 12 months without a period or bilateral oophorectomy or complete chemical ovarian suppression for the past 12 months with continued suppression planned throughout the course of the study
- FSH and an estradiol value in the postmenopausal range (generally FSH >40 IU/L and estradiol < 10 pg/mL, depending on laboratory) if 9 months without a period OR post hysterectomy with at least one ovary remaining and less than 55 years old
- For age 55 or older, menopausal status does not need to be determined by laboratory exams
- Significant vaginal complaints defined as persistent vaginal dryness and/or pain with intercourse (dyspareunia) of sufficient severity to make a patient desire therapeutic intervention
- Eligibility questionnaire response must be moderate or worse levels of severity on one of the two symptoms, either dryness or dyspareunia
- Vaginal symptoms must have been present ≥ 2 months prior to randomization
- Life expectancy > 12 months
- ECOG performance status 0 or 1
- Ability to complete questionnaires by themselves or with assistance
- Willing to return to NCCTG enrolling institution for follow-up
- Willing to provide blood samples for correlative research purposes
- Willing to undergo brief pelvic exam at baseline and week 11-12, if institution participating in that portion of the study
- No current diagnosis of an active vaginal infection; if symptoms of vaginal infection (i.e., foul discharge, fever) present, then infection must be ruled out
- No diagnosis of any of the following conditions within the past five years:
- Essential vulvodynia
- Vulvar vestibulitis
- Bartholin cyst/abscess
- History of Bartholin gland surgery
- Lichen sclerosis
- Lichen planus of the vulvovaginal region
- Desquamative vaginitis
- No history or current diagnosis of any of the following conditions (ever):
- Vulvar or vaginal dysplasia
- Vaginal prolapse
- No women of childbearing potential or premenopausal women
PRIOR CONCURRENT THERAPY:
- No initiation or discontinuation of tamoxifen or aromatase inhibitors ≤ 2 months prior to randomization or plan to initiate or discontinue any of these medications during the 12-week study
- No concurrent chemotherapy
- Long-term adjuvant trastuzumab, lapatinib, and/or bevacizumab is allowed
- Not planning to use any vaginal preparations during the study period (including any over-the-counter or herbal preparations)
- Water-based lubricants, such as KY jelly, are allowed during sexual intercourse
- No use of any daily non-hormonal vaginal preparations ≤ 1 week prior to study entry
- Patients who stop agent may be enrolled after 1 week
- More then 4 weeks since prior and no concurrent use of any estrogen product or any kind of hormonal vaginal product including bio-identical hormones, estriol, or any androgen product
- No concurrent pharmacologic soy or phytoestrogen preparations (dietary intake of soy [i.e., soy milk] is acceptable)
- Not on a placebo-controlled trial for endocrine therapy
- No prior or concurrent pelvic radiotherapy
- No prior radical pelvic surgery, specifically vaginectomy or pelvic exenteration
- Prior total abdominal hysterectomy (TAH) and/or bilateral salpingo-oophorectomy (BSO) allowed
Trial Lead Organizations/Sponsors
North Central Cancer Treatment GroupNational Cancer Institute
|Debra Barton||Principal Investigator|
|St. Francis Hospital and Health Centers - Beech Grove Campus|
|Howard M. Gross||Ph: 765-983-3000|
|Genesys Hurley Cancer Institute|
|Philip J. Stella||Ph: 734-712-3456|
|Lake Region Healthcare Corporation-Cancer Care|
|Preston D. Steen||Ph: 701-234-6161|
|AnMed Cancer Center|
|James Dewitt Bearden||Ph: 800-486-5941|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01376349
ClinicalTrials.gov processed this data on October 17, 2013
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