Harada, K., Ferdous, T., Horinaga, D., Uchida, K., Mano, T., Mishima, K., . . .  Fukunaga, M. (2016). Efficacy of elemental diet on prevention for chemoradiotherapy-induced oral mucositis in patients with oral squamous cell carcinoma. Supportive Care in Cancer, 24, 953–959. 

To evaluate effects of an elemental diet for prevention of radiotherapy or chemotherapy-induced oral mucositis in patients with oral cancer

Data were collected from medical record review.  All patients received 2 Gy per day, fives days per week to the oral cavity for a total dose of 60-70 Gy with or without concurrent chemotherapy. 80 g of elemental diet powder was dissolved in 300 ml of water for patients to swish around in the mouth and swallow once daily. All patients were to follow a similar regimen of oral brushing, gargling with 4% azulene sodium sulfonate and water, lidocaine gargle, NSAIDs, and/or opioids as needed for pain. Data were compared between those who had received the elemental diet versus individuals who had not.

• N: 74
• AGE: Mean = 64.9, range = 30-91
• MALES: 67.6%        
• FEMALES: 32.4%
• KEY DISEASE CHARACTERISTICS: Squamous cell cancer – most located on the tongue or gingiva.  All were stage III or IV

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

• PHASE OF CARE: Active antitumor treatment

• Retrospective Two group cohort comparison

• CTCAE version 4

Mulivariate analysis showed that use of the elemental diet (p = 0.004) and no concurrent chemotherapy (p = 0.004) were significant factors to predict the grade of mucositis observed. For those getting RT only, the incidence of grade 3 or 4 mucositis was lower in the group who had the elemental diet, but the difference was not statistically significant. For those getting both chemotherapy and radiation therapy (n = 49 patients), rates of more severe mucositis were 79.2% among controls and 40% in the elemental diet group (p = 0.005).

Having patients swish and swallow an elemental diet preparation appeared to reduce the severity of oral mucositis in patients with oral cancer getting combined radiation and chemotherapy.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)

Administration of an elemental diet preparation as used here might have a protective effect to reduce severity of oral mucositis in patients with oral cancer getting combined radiation and chemotherapy. This is a low-risk type of intervention that warrants further investigation. Prospective, well-designed trials are needed to establish efficacy.