Ertekin, M.V., Koc, M., Karslioglu, I., & Sezen, O. (2003). Zinc sulfate in the prevention of radiation-induced oropharyngeal mucositis: A prospective, placebo-controlled, randomized study. International Journal of Radiation Oncology, Biology, Physics, 58(1), 167–174.

Intervention Characteristics/Basic Study Process

Zinc sulfate (50 mg zinc) capsules TID at 8 hr intervals. Began day 1 of radiation, during RT, and for 6 weeks after.

Oral hygiene for all patients: drink water, brush with soft brush after each meal and with mouth jellies, including fluoride. Patients were instructed to avoid alcoholic drinks, not smoke cigarettes, not drink liquids that were too hot or too cold, not eat excessive spiced or sour foods, and to not eat hard foods.
 

Sample Characteristics

The study was comprised of 30 patients, 15 zinc, 12 placebo (3 excluded), age 18-71, with a median age of 54 years.

  • Head and neck RT or chemo + RT
  • Median rad dose 6400 cGy
  • May 2001 – May 2002

Study Design

Prospective, randomized placebo-controlled study

Measurement Instruments/Methods

Assessed by two radiation MDs using RTOG morbidity scoring

Results

13 of 15 zinc patients developed mucositis; however, no patientss developed grade 4 mucositis.
Gr 1 – 8 pts versus  0
Gr 2 – 5 pts versus 4
Gr 3 – 0 pts versus  8
Gr 4 – 0 pts versus 0

Greater severity p = 0.05

Mucositis developed later in the zinc group (p < 0.05) and  at a higher RT dose (p < 0.01)

At six weeks, only one patient in the zinc group had mucositis, while 10 of 12 patients in the placebo group had mucositis, p < 0.01.

Well tolerated
 

Limitations

Local anesthetic solutions and analgesic agents were given to patients for pain.

Very small study

Need to ensure validity of MD evaluation and other agents used.