Androgen deprivation therapy (ADT) may cause vasomotor symptoms (VMS) including hot flushes and sweats, which affect quality of life (QoL). Serelys Homme is a nonhormonal and a natural origin product that could affect VMS in men undergoing ADT. We evaluated effectiveness and tolerance of Serelys Homme administration on VMS and QoL of patients undergoing combined ADT and radiation therapy for prostate cancer.
Between April 2017 and July 2019, 103 patients were screened, and 53 patients refused to participate in the study. Serelys Homme therapy consisted of a daily administration of 2 tablets for 6 months. Patients were evaluated with 4 questionnaires including the adapted Modified Rankin Scale (adapted-MRS), European Quality of Life 5 Dimensions 3 Level Version (EQ 5D3L), Functional Assessment of Cancer Therapy-Prostate (FACT-P), and Hot Flash Related Daily Interference Scale (HFRDIS) at day 0, day 90 (D90), and day 180 (D180). Statistical evaluation was performed using the Wilcoxon rank sign test. A 2-sided P < .05 was considered statistically significant.
Among the 50 patients, 4 withdrew after inclusion. All patients (n = 46) received either postoperative or definitive radiation therapy combined with a short (n = 15) or long course (n = 31) of ADT. Serelys Homme administration significantly decreased the rate of patients who had ≥7 VMS and 3 to 6 VMS per day. The number of patients presenting with moderate or severe VMS was decreased at D90 (P = .005) and at D180 (P = .005). In addition, VMS duration was reduced at D90 (P = .002) and D180 (P < .001). Finally, at D90 and D180, 11.1% and 16.0% of patients, respectively, with initial severe or moderate VMS had a complete response without further symptoms. Among QoL parameters, fatigue decreased significantly. Effectiveness evaluated by doctors was rated as moderate or good to excellent VMS control in 20% and 60% of the patients, respectively. No side effects were recorded in the whole population.
This study demonstrated effectiveness and excellent tolerance of Serelys Homme. We observed a significant reduction of the frequency, duration, and intensity of hot flushes and sweats induced by ADT. Serelys Homme increased QoL scores. These encouraging results open the prospect to further studies and Serelys Homme use in patients undergoing ADT for prostate cancer.
Advances in radiation oncology. 2023 Apr 24*** epublish ***
Yazid Belkacemi, Gabriele Coraggio, Anne Brunel, Annie Jouhaud, Alexandre Ingels, Charlotte Joly, Asma Hadhri, Wissal Hassani, Gokoulakrichenane Loganadane, Carolina Saldana, Nabila Ouidir, Barbara Vega, Kamel Debbi, Alexandre de La Taille
Assistance Publique - Hôpitaux de Paris (AP-HP), Radiation Oncology Department and Henri Mondor Breast Center, Henri Mondor University Hospital, Créteil, France., Biostatistics, Stateo, Fontvieille, Monaco., Urology Department, Henri Mondor University Hospital, University of Paris-Est Créteil (UPEC), Créteil, France., Medical Oncology Department, Henri Mondor University Hospital, Créteil, France., Pathology Department, Henri Mondor University Hospital, Créteil, France., Medical Department, Sérélys Pharma, Fontvieille, Monaco.