Prasterone (Dehydroepiandrosterone) in Treating Postmenopausal Cancer Survivors With Vaginal Symptoms
Condition: Breast Cancer; Gynecologic Cancer
MeSH terms: Breast Neoplasms
Intervention: prasterone; placebo
Intervention description: Applied vaginally; Applied vaginally
Intervention MeSH terms: Dehydroepiandrosterone
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 464.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: depression; anxiety disorder; cognitive/functional effects; sexual dysfunction; cancer survivor; breast cancer; cervical cancer; fallopian tube cancer; uterine sarcoma; vaginal cancer; vulvar cancer; ovarian epithelial cancer; ovarian germ cell tumor; ovarian sarcoma; ovarian stromal cancer; primary peritoneal cavity cancer; endometrial cancer

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age ≥ 18 years

          2. Postmenopausal women with a history of breast or gynecologic cancer (currently no
             evidence of disease). Note: Postmenopausal status will be determined by the following
             criteria:

               1. 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

               2. menopausal status will be determined by an FSH and an estradiol value in the
                  postmenopausal range (generally FSH > 40IU/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. Note: if age 55 or older with these criteria, then menopausal status
                       does not need to be determined by labs

          3. Significant vaginal complaints. Note: Defined as persistent vaginal dryness and/or
             pain with intercourse (dyspareunia) of sufficient severity to make a patient desire
             therapeutic intervention.

          4. Eligibility questionnaire response must be moderate or worse levels of severity on one
             of the two symptoms, either dryness or dyspareunia. The protocol contains more
             information.

          5. Vaginal symptoms must have been present ≥ 2 months prior to randomization.

          6. Life expectancy > 12 months.

          7. Ability to complete questionnaires by themselves or with assistance.

          8. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.

          9. The patient must provide informed written consent.

         10. Willing to return to the enrolling institution for follow-up.

         11. Willing to provide blood samples for correlative research purposes.

        Exclusion Criteria:

          1. Initiation or discontinuation of tamoxifen or aromatase inhibitors ≤ 2 months prior to
             randomization or plans to initiate or discontinue any of these medications during the
             12-week study.

          2. Current diagnosis of an active vaginal infection, if symptoms of vaginal infection,
             this must be ruled out (ie, foul discharge, fever).

          3. Concurrent chemotherapy (long term adjuvant herceptin, lapatanib, and/or bevacizumab
             is allowed.

          4. Planned use of any vaginal preparations during the study period (including any over
             the counter or herbal preparations). Note: Water-based lubricants (such as KY jelly)
             are allowed during sexual intercourse.

          5. Use of any daily non-hormonal vaginal preparations ≤ 1 week prior to study entry.

             Exception: Daily water-based lubricants for sexual intercourse. Note: Patients who
             stop agent may be enrolled after one week.

          6. Current (≤ 4 weeks prior to randomization), or planned during the study period, use of
             any estrogen product or any kind of hormonal vaginal product including bioidentical
             hormones, estriol or any androgen product.

          7. Use of pharmacologic soy or phytoestrogen preparations (Dietary intake of soy - ie
             milk is acceptable).

          8. On a placebo controlled trial for endocrine therapy.

          9. Prior or concurrent pelvic radiation therapy.

         10. Prior radical pelvic surgery, specifically vaginectomy or pelvic exenteration
             (TAH/BSO) is allowed).

         11. Diagnosis of any of the following conditions within the past five years:

               1. Essential vulvodynia

               2. Vulvar vestibulitis

               3. Bartholin cyst/abscess

               4. History of Bartholin gland surgery

               5. Lichen sclerosis

               6. Lichen planus of the vulvovaginal region

               7. Desquamative vaginitis

         12. History or current diagnosis of any of the following conditions:

               1. Vulvar or vaginal dysplasia

               2. Vaginal prolapse

         13. Women of childbearing potential, premenopausal women.