Antonadou, D., Pepelassi, M., Synodinou, M., Puglisi, M., & Throuvalas, N. (2002). Prophylactic use of amifostine to prevent radiochemotherapy-induced mucositis and xerostomia in head-and-neck cancer. International Journal of Radiation Oncology, Biology, Physics, 52, 739–747.

DOI Link

Intervention Characteristics/Basic Study Process

Patients in the study group received 300 mg/mamifostine 15–30 minutes before radiation therapy (RT) on days 1–5 of each week. Patients in both the study group and the control group received 90 mg/mcarboplatin once per week before RT. Treating physicians and patients reported data.

Sample Characteristics

  • The study enrolled 50 patients. Of these, 45 were assessable (22 in the study group and 23 in the control group).
  • More men than women participated.
  • The mean age was 59 years with a  range of 45–74 years.

Setting

The study was conducted between January 1997 and January 1998.

Measurement Instruments/Methods

The Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer (RTOG/EORTC) 0–4 grading system was used.

Results

  • Mucositis increased from baseline to grade 2 more rapidly in the control group by week 3.
  • In the control group, 23 patients (100%) experienced grade 2 mucositis versus only two patients (91%) in the study group (p < 0.0001).
  • Most patients receiving amifostine (77.2%) experienced mild mucositis (grade 2) versus only 21% in the control group (p = 0.0001).
  • During week 5, 52% of patients in the control group had grade 4 mucositis versus 4.5% of patients in the study group (p = 0.0006).
  • The majority of patients in the control group (95.7%) experienced moderate to severe mucositis versus 63.6% of patients in the study group (p = 0.0098).
  • Incidence of side effects was low with nausea and vomiting (4.5%) and hypotension (13.6%) most common.

Limitations

  • The sample size was small, and the study was not blineded.
  • Limited mucositis data were presented.