Effectiveness Not Established

Elemental Diet and Oral Rinse

for Mucositis

An elemental diet contains easily absorbable proteins in the form of amino acids, very minimal fat content, and easily absorbable vitamins and mineral content. Elemental diets have been used to maintain nutrition and reduce diarrhea (because absorption in the upper intestine can reduce stool volume) in patients with inflammatory bowel diseases. Use of an elemental diet formula was studied in patients with cancer for its effect on radiation-induced diarrhea (Russell, 1975). Use of an elemental diet as an oral rinse prior to swallowing has been tested for its effect on mucositis.

Russell, R.I. (1975). Progress Reports: Elemental diets. Gut, 16, 68–79. Retrieved from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1410941/pdf/gut00494-0076.pdf

Research Evidence Summaries

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. 

Study Purpose

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

Intervention Characteristics/Basic Study Process

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.

Sample Characteristics

  • 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 and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

  • Retrospective Two group cohort comparison

Measurement Instruments/Methods

  • 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)


Nursing Implications

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.