Bonfili, P., Gravina, G.L., Marampon, F., Rughetti, A., Di Staso, M., Dell'Orso, L., . . . Di Cesare, E. (2015). Oral platelet gel supernatant plus supportive medical treatment versus supportive medical treatment in the management of radiation-induced oral mucositis: A matched explorative active control trial by propensity analysis. American Journal of Clinical Oncology. Advance online publication. 

To examine the use of oral platelet gel supernatant with supportive medical treatment versus supportive medical treatment alone in the management of radiation-induced oral mucositis (OM) in patients with head and neck cancer

The intervention group was a prospective sample of patients receiving treatment for head and neck cancer, and controls were historical controls. The intervention and control groups received supportive measures maintaining adequate hydration, nutritional status, and oral hygiene, including mild-flavored toothpaste, saline peroxide mouthwash three to four times a day, and an antifungal agent. The intervention group also received platelet gel supernatant (PGS) three times per day one hour before breakfast, lunch, and dinner. PGS treatment was started on the first day of radiation or chemoradiation treatment and stopped at the end of the radiation course. Patients were monitored during treatment and as many as seven weeks after treatment completion. OM was assessed by two radiation oncologists.

• N = 80
• AGE RANGE = 47–65 years (intervention), 51–63 years (control)
• MALES: 62%, FEMALES: 38%
• KEY DISEASE CHARACTERISTICS: Radiation-induced mucositis
• OTHER KEY SAMPLE CHARACTERISTICS: Patients with nonmetastatic head and neck cancer treated with radiation with or without chemotherapy

• SITE: Single site    
• SETTING TYPE: Not specified    
• LOCATION: San Salvatore Hospital

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Elder care and palliative care 

Quasi-experimental

• The World Health Organization (WHO) score of OM was used to grade the severity of oral mucositis.
• The ​Oral Mucositis Questionnaire Head and Neck (OMQ-HN) was used to assess quality of life.

The intervention group experienced a decrease in the severity of WHO grade 3 and 4 toxicity that was statistically significant (p = 0.0074). The intervention group also showed a later onset of mucositis based on the WHO grade toxicity and higher quality of life as measured by OMQ-HN (p = 0.001). A greater decrease in the use of opioid analgesics was found in the intervention group (p = 0.0021) compared to the control group.

A decrease in WHO grades 3 and 4 toxicity and a slower symptom onset was demonstrated with PGS administration.

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

PGS in combination with supportive therapy is potentially beneficial in the management of radiation-induced OM. The intervention was aimed at affecting OM. Using the WHO grading scale, a delay in OM development was seen; however, some patients did not receive chemotherapy, and certain drugs exacerbate OM. Additional studies in in populations receiving radiation and chemotherapy are needed.