Statement: Cohort 2 of the primary trial is the control group and cohort 1 is the control group in the secondary trial.
Primary_evidence: INTERVENTION 1:    Arm I (Cranial Microcurrent Electrical Stimulation [CES])   Patients receive a CES unit (Alpha-Stim® 100 Microcurrent Stimulator) that passes microcurrent levels of biphasic electrical stimulation via ear-lobe electrodes. The CES unit is preset to provide 1 hour of 100 μA (sub-sensory level), modified square-wave biphasic stimulation on a 50% duty cycle at .05 Hz, and to automatically turn off at the end of 1 hour. Patients use their CES unit once daily in weeks 1-18.   energy-based therapy: Given once a day for 18 weeks INTERVENTION 2:    Arm II (Sham CES)   Patients receive a CES unit as in arm I, but the ear-lobe electrodes do not pass electrical current. Patients use their CES unit once daily in weeks 1-18.   sham intervention: Given once a day for 18 weeks
Secondary_evidence: INTERVENTION 1:    Treatment Gel + Oral Placebo   4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.   oral placebo: Oral placebo taken daily for 4-10 weeks.   afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks. INTERVENTION 2:    Placebo Gel + Oral Treatment   Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).   tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.   placebo gel: Placebo gel applied to breasts daily for 4-10 weeks.