Effects of tibolone and hormone therapy (estradiol and medroxyprogesterone acetate) on the late toxic effects of radiotherapy in cervical cancer survivors: a prospective, double-blind, randomized, placebo-controlled trial

Abstract

Purpose: The primary objective of this study was to investigate the efficacy of tibolone and estrogen therapies to prevent the late toxic effects of radiotherapy in the vagina in cervical cancer survivors who received radiotherapy. A secondary objective included how these therapies affected sexual life. Material and Methods: In the placebo arm, the patients received a placebo. In the tibolone arm, the patients received tibolone at a dosage of 2.5 mg daily. In the estrogen arm, patients received 0.625 mg estradiol (E2) and five mg medroxyprogesterone acetate (IVEPA) daily. The patients were assessed with the LENT-SOMA (Late Effects Normal Tissues-Subjective Objective Management and Analytic) scoring system, vaginal impression, female sexual function index (FSFI), and routine gynecological examination. Results: The LENT SOMA total score was significantly higher in the baseline measurement in all arms of the study (p<0.001). The vaginal length significantly increased in the tibolone arm (7.17 +/- 0.98 vs. 7.69 +/- 0.91;p<0.001) and E2/MPA arm (7.29 +/- 1.37 vs. 7.80 +/- 1.29; p = 0.005). The changes in FSFI total score significantly improved in the tibolone arm (16.06 +/- 6.92 vs. 22.19 +/- 6.14 vs. 26.02 +/- 12.35;p = 0.042). Conclusions: The evidence suggested that short-term tibolone or E2/MPA use appeared to reduce the late toxic effects of radiotherapy and increase the vaginal measurements, while tibolone improved sexual function especially, in cervical cancer survivors.