Camellia and Wheat Extract

Camellia and Wheat Extract

PEP Topic 
Mucositis
Description 

Camellia sinensis leaf extract is derived from green tea and has antioxidative properties. Palmitoyl hydrolyzed wheat protein is a condensation product of palmitic acid chloride and hydrolyzed wheat protein. This protein is believed to have healing properties for skin and mucosa. Camellia sinensis leaf extract and palmitoyl hydrolyzed wheat protein are active ingredients in Baxidil Onco®, which has been studied in patients with cancer to treat oral mucositis.

Effectiveness Not Established

Research Evidence Summaries

Carulli, G., Rocco, M., Panichi, A., Chios, C.F., Ciurli, E., Mannucci, C., . . . Petrini, M. (2013). Treatment of oral mucositis in hematologic patients undergoing autologous or allogeneic transplantation of peripheral blood stem cells: A prospective, randomized study with a mouthwash containing Camelia Sinensis leaf extract. Hematology Reports, 5, 21–25.

doi: 10.4081/hr.2013.e6
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Study Purpose:

To examine the effectiveness of Camelia Sinensis leaf extract to prevent oral mucositis (OM) in patients undergoes autologous and allogeneic stem cell transplant (SCT)

Intervention Characteristics/Basic Study Process:

Patients undergoing SCT randomly were assigned to the experimental group or the control group. Patients in the experimental group received 20 ml of Baxidil Onco® four times a day from day -1 to day +30, in addition to standard prophylactic measures. Baxidil Onco is composed of Camelia Sinensis leaf extract and palmitoyl hydrolyzed wheat protein. Patients in the control group received standard prophylactic measures only. As a standard measure, all patients received mouthwashes with 0.9% saline/sodium bicarbonate solution, 0.12% chlorhexidine, and amphotericin B. 

Patients with grade 2 or higher OM additionally received oral care with sponges or soft gauzes. All patients also received 400 mg acyclovir twice daily from day -3 to 16 weeks, 400 mg fluconazole once daily, 500 mg ciprofloxacin once daily, and 960 mcg co-trimoxazole twice daily until day of transplant.

Sample Characteristics:

  • N = 60; 28 in the experimental group, 32 in the control group
  • AGE RANGE: 21–72 years
  • MALES: 65%, FEMALES: 35%
  • KEY DISEASE CHARACTERISTICS: Diagnoses were multiple myeloma (n = 23), B-cell non-Hodgkin lymphoma (n = 14), acute myeloblastic leukemia (n = 10), acute lymphoblastic leukemia (n = 7), chronic lymphocytic leukemia (n = 2), primary myelofibrosis (n = 1), myelodysplastic syndrome (n = 1), paroxysmal nocturnal myelodysplastic (n = 1), and Hodgkin lymphoma (n = 1).

Setting:

  • SITE: Single site
  • SETTING TYPE: Inpatient
  • LOCATION: Italy

Phase of Care and Clinical Applications:

PHASE OF CARE: Active antitumor treatment

Study Design:

  • Randomized, non-blinded, experimental study

Measurement Instruments/Methods:

  • World Health Organization (WHO) Oral Toxicity Scale
  • Greene and Vermillion's Oral Hygiene Index (OHI-S)
  • Total morphine use also was recorded.

Results:

OM was found in 81.2% of patients in the control group and 50% of patients in the study group (p = 0.022). Incidence rates for patients undergoing allogeneic transplant were 89% in the control group and 64% in the study group. Moderate to severe mucositis was more prevalent in the control group (56.2%) than in the study group (25%) (p = 0.029). No statistically significant results were found in incidence of severe mucositis (p = 0.16). Total requirement of morphine was 1,300 mg for the study group and 2,880 mg in the control group. However, this result was not statistically examined.

Conclusions:

Baxidil Onco may be effective in reducing OM in patients undergoing hematopoietic SCT. A caution may apply for patients with wheat allergy. More patients were undergoing allogeneic transplant in the control group than in the study group. Because incidence of mucositis generally is higher in allogeneic hematopoietic SCT, this presents a potential bias. Further study with larger sample sizes is necessary.

Limitations:

  • Small sample (< 100)
  • Risk of bias (lack of blinding and sample characteristics)

Nursing Implications:

Baxidil Onco may help reduce OM for patients undergoing hematopoietic SCT. However, further study with larger sample sizes is necessary for this to be used as a standard of practice. 


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