Carpenter, J.S., Storniolo, A.M., Johns, S., Monahan, P.O., Azzouz, G., Elam, J.L., . . . Shelton, R.C. (2007). Randomized, double-blind, placebo-controlled crossover trials of venlafaxine for hot flashes after breast cancer. Oncologist, 12(1), 124–135.

Each study intervention lasted for 14 weeks. The low-dose study treatment required patients to take 37.5 mg/day of venlafaxine. The high-dose treatment required patients to take venlafaxine at 37.5 mg/day for one week, followed by 75 mg/day for four weeks, followed by 37.5 mg/day for one week. Women were scheduled for 14 weekly visits. Weeks 1 and 2 provided baseline information, and weeks 3–14 consisted of six weeks of treatment (T1–T6) and six weeks of placebo (P1–P6). Trained nurses visited patients in the clinic, at home, or in their workplace to maintain consistent follow-up. Patients were telephoned 1, 6, and 12 months after completing the weekly visits to assess continued venlafaxine use.

• The study included 77 breast cancer survivors.
• Low-dose study group
  • Mean age = 50.5 years, mainly non-Hispanic whites (91%), married (81%), and working full-time (60%).
  • Mostly stage II or less at diagnosis (96%), and had received radiation (68%), chemotherapy (70%), or both (51%).
  • 51% were taking endocrine therapy.
• High-dose study group:
  • Mean age = 53 years, mostly non-Hispanic whites (90%), married (53%), and working full-time (63%)
  • Mostly stage II or less at diagnosis (94%), taking endocrine therapy (63%), had received radiation (58%), chemotherapy (63%), or both (38%).
• Patients were excluded if they used tamoxifen or aromatase inhibitor for less than six weeks, were taking antidepressants, received hot flash treatment within the past four weeks, or were pregnant or lactating.

The study was conducted in university cancer clinics in the southeast (low-dose study) and midwest (high-dose study) United States.

Active treatment

Randomized, Double-blind, placebo-controlled, crossover trials:

1. Low-dose study (N=57)
2. High-dose study (N=20)

Profile of Mood States–Short Form (fatigue subscale)

Overall fatigue did not improve with the venlafaxine treatment when compared with the placebo. However, a subgroup of 15 women who received venlafaxine and had a 50% or greater decrease in physiologic hot flashes experienced a significant improvement in fatigue from baseline to six weeks compared to the placebo group (p = 0.007).

Homogenous sample in respect to race and ethnicity Small sample size Limited treatment time Lack of pharmacogenetic data (i.e. did not evaluate genetic polymorphisms in patients which may have explained observed response to venlafaxine treatment