Clinical evaluation of human placental extract (placenterex) in radiation-induced oral mucositis

To evaluate human placental extract in the treatment of radiation mucositis involving the oral/oropharyngeal region, a prospective randomized study wa s carried out in 120 patients with squamous cell carcinoma of the head and neck from August 1997 to March 1999. The study was conducted in patients re ceiving radical external radiation therapy, planned for =>60 Gy/30F/6 weeks , who developed grade 2 radiation mucositis (patchy mucositis) during radia tion treatment, The patients were randomized in two groups of 60 patients e ach to receive either placentrex treatment (placentrex group) or convention al treatment (control group). Placentrex treatment was given as Inj Placent rex 2 ml by deep intramuscular injection 5 days a week for 15 injections. C onventional treatment given in the control group was disprin gargles and be tamethasone oral drops. A subjective decrease in pain was observed in 48/60 (80%) of patients in the placentrex group compared with 22/60 (36.7%) in t he control group. The progression to grade 3 radiation mucositis was 24/60 (40%) in the placentrex group compared with 52/60 (86.7%) in the control gr oup. The subjective improvement in difficulty in swallowing was seen in 56/ 60 (93%) of patients in the placentrex group compared with 9/60 (15%) of pa tients in the control group. Only one patient in the placentrex group compa red with three in the control group required interruption of radiation ther apy because of severe radiation reactions. Human placental extract appears to be effective in the management of radiation-induced oral/oropharyngeal m ucositis and especially in controlling subjective symptoms.