Sangthawan, D., Phungrassami, T., & Sinkitjarurnchai, W. (2013). A randomized double-blind, placebo-controlled trial of zinc sulfate supplementation for alleviation of radiation-induced oral mucositis and pharyngitis in head and neck cancer patients. Journal of the Medical Association of Thailand = Chotmaihet Thangphaet, 96, 69–76.

To determine the efficacy of zinc sulfate supplements in reducing oral mucositis in patients with head and neck cancer

Patients were randomized to receive zinc supplementation or placebo during radiation therapy. Patients received 50 mg zinc sulfate daily at meal times in a syrup form or an identical placebo syrup. All patients received visous Xylocaine^® and analgesics as considered necessary. The primary study end point was to evaluate the frequency of development of greater than grade 2 mucositis and pharyngitis.

• N = 139   
• MEAN AGE = 62 years
• MALES: 86.8%, FEMALES: 13.2%
• KEY DISEASE CHARACTERISTICS: 53% had stage 3–4 disease, 85% were smokers, and 76% used alcohol

• SITE: Single site  
• SETTING TYPE: Not specified   
• LOCATION: Thailand

• PHASE OF CARE: Active antitumor treatment

• Double-blind, placebo-controlled

• National Cancer Institute Common Toxicity Criteria version 2
• Visual analog scale for pain scoring

There was no difference between groups in proportion with greater than grade 2 mucositis. Seventeen percent in the placebo group and 23% in the zinc sulfate group developed grade 3 mucositis. There were no significant group differences in pain severity.

Zinc sulfate supplementation during radiation therapy for head and neck cancer did not produce any benefit in reducing or relieving symptoms of oral mucositis.

• Measurement/methods not well described
• Other limitations/explanation: Timing of pain rating and data used were not well described.

There was no benefit of zinc supplementation for the prevention and management of oral mucositis in this group of patients.