Research & Trial Information
Protocol #: NRG -CC004
Cancer Type: Cancer Control Gynecology
- Diagnosis of breast or gynecologic cancer (DCIS, ovarian, endometrial, vulvar, cervical and vaginal)
2. Completed definitive therapy consisting of surgery, chemotherapy or radiation therapy at least 180 days ago (may continue on Herceptin or endocrine therapy)
3. Post menopausal as defined by at least ONE of the following:
• 12 months (365 days) without a period,
• Bilateral oophorectomy,
• At least one ovary and woman has had hysterectomy, must have FSH (>30mIU/mL) and estradiol in menopausal range per institution’s laboratory (<10 for ultra sensitive assay: <25-30 otherwise);
• At least one ovary intact and 180 days without a period with FSH (>30mIU/mL) and estradiol in menopausal range per institution’s laboratory (<10 for ultra sensitive assay: <25-30 otherwise)
4. Age ≥ 18
5. History, Physical and Performance Status of 2 or less within 180 days prior to registration.
6. For breast cancer patients only, endocrine therapies are allowed (such as aromatase inhibitors, but tamoxifen is not allowed).
7. Vaginal estrogen is allowed, for all protocol disease sites, if dose equal to or less than that in estring (<7.5 mcg) and it has been used for at least 30 days with no plans to stop or alter use during the course of the study.
8. Antidepressants for mood and hot flashes, including SSRI’s will be allowed if patients have been on a stable dose for the last 60 days and the dose is not expected to change during the course of the study. Only subthreshold or low dose antidepressants will be allowed (i.e. Effexor 37.5 -75 mg or Lexapro 5-10 mg or Celexa 10 – 20 mg).
9. Women who report that their motivation/desire for sexual intimacy has decreased since her cancer diagnosis.
10. Able to swallow whole capsules.