Efficacy of a maintenance therapy with supplements containing indole-3-carbinol (I3C) and epigallocatechin-3-gallate (EGCG) in ovarian cancer patients

Arm 1 Patients of Arm 1 received neoadjuvant chemotherapy consisted of 2–4 cycles of TP regimen (1st day: paclitaxel 175 mg/m^2 by intravenous 3-h infusion with pre-medication; 2nd day: cisplatin 75-100 mg/m^2 by intravenous >= 1-h infusion with hyper-hydration) or TC regimen (1st day: paclitaxel 175 mg/m^2 by intravenous 3-h infusion with pre-medication; 2nd day: carboplatin AUC 5 by intravenous >= 1-h infusion), every 21 days. Surgical treatment (panhysterectomy with subtotal resection of the greater omentum and the maximum removal of disseminated tumor foci) was carried out 24 days after the last cycle of neoadjuvant chemotherapy. 14 days after surgery patients were treated with postoperative adjuvant chemotherapy consisted of 5-6 cycles of TP regimen or TC regimen every 21 days. Maintenance therapy with oral administration of Indinol Forto (Registered Trademark) (200 mg of I3C 2 times a day continuously) was started 14 days before the primary neoadjuvant therapy and continued after completion of postoperative adjuvant chemotherapy for 5 years of the study. The number of cycles of chemotherapy depends on time of achieved CA-125 level =<35 U/mL and general declining profile of CA-125; the number of cycles of chemotherapy also varied depending on set of clinical and laboratory data, including physical condition. Arm 2 Patients of Arm 2 received neoadjuvant chemotherapy consisted of 2–4 cycles of TP regimen (1st day: paclitaxel 175 mg/m^2 by intravenous 3-h infusion with pre-medication; 2nd day: cisplatin 75-100 mg/m^2 by intravenous >= 1-h infusion with hyper-hydration) or TC regimen (1st day: paclitaxel 175 mg/m^2 by intravenous 3-h infusion with pre-medication; 2nd day: carboplatin AUC 5 by intravenous >= 1-h infusion), every 21 days. Surgical treatment (panhysterectomy with subtotal resection of the greater omentum and the maximum removal of disseminated tumor foci) was carried out 24 days after the last cycle of neoadjuvant chemotherapy. 14 days after surgery patients were treated with postoperative adjuvant chemotherapy consisted of 5-6 cycles of TP regimen or TC regimen every 21 days. Maintenance therapy with oral administration of Promisan (Registered Trademark) (200 mg of I3C + 100 mg of EGCG 2 times a day continuously) was started 14 days before the primary neoadjuvant therapy and continued after completion of postoperative adjuvant chemotherapy for 5 years of the study. The number of cycles of chemotherapy depends on time of achieved CA-125 level =<35 U/mL and general declining profile of CA-125; the number of cycles of chemotherapy also varied depending on set of clinical and laboratory data, including physical condition. Arm 3 Patients of Arm 3 received neoadjuvant chemotherapy consisted of 2–4 cycles of TP regimen (1st day: paclitaxel 175 mg/m^2 by intravenous 3-h infusion with pre-medication; 2nd day: cisplatin 75-100 mg/m^2 by intravenous >= 1-h infusion with hyper-hydration) or TC regimen (1st day: paclitaxel 175 mg/m^2 by intravenous 3-h infusion with pre-medication; 2nd day: carboplatin AUC 5 by intravenous >= 1-h infusion), every 21 days. Surgical treatment (panhysterectomy with subtotal resection of the greater omentum and the maximum removal of disseminated tumor foci) was carried out 24 days after the last cycle of neoadjuvant chemotherapy. 14 days after surgery patients were treated with postoperative adjuvant chemotherapy consisted of 5-6 cycles of TP regimen or TC regimen every 21 days. Patients also received long-term chemotherapy TP regimen or TC regimen after the last cycle of postoperative adjuvant chemotherapy every 2-3 months for 5 years of the study. Maintenance therapy with oral administration of Promisan (Registered Trademark) (200 mg of I3C + 100 mg of EGCG 2 times a day continuously) was started 14 days before the primary neoadjuvant therapy and continued after completion of postoperative adjuvant chemotherapy for 5 years of the study. The number of cycles of chemotherapy depends on time of achieved CA-125 level =<35 U/mL and general declining profile of CA-125; the number of cycles of chemotherapy also varied depending on set of clinical and laboratory data, including physical condition. TP or TC regimen was chosen randomly. Adherence to the intervention was measured by counting returned tablets and checking diaries of self-control.