Pimenta Amaral, T. M., Campos, C. C., Moreira Dos Santos, T. P., Leles, C. R., Teixeira, A. L., Teixeira, M. M., et al. (2012). Effect of salivary stimulation therapies on salivary flow and chemotherapy-induced mucositis: a preliminary study. Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology, 113(5), 628-637.

Analyze the effectiveness of two noninvasive mechanical and electrical therapies on salivary flow and severity of oral mucositis in patients undergoing allogeneic HCT.

INTERVENTION DESCRIPTION
Patients undergoing myeloablative conditioning for allogeneic HCT  were randomized to four groups: (1) control group (no salivary stimulation therapy, (2) salivary stimulation using a mechanical chewing instrument, (3) TENS stimulation, and (4) combination of TENS and mechanical chewing. Saliva samples were obtained twice before HCT and three times after transplantation. Severity of mucositis was evaluated by a single examiner four days per week from day 7 to day 30 post-HCT.  Patients assigned to the mechanical chewing used a silicone instrument and were instructed to perform mastication exercises after meals 4 times daily for 10 minutes. TENS stimulation was given 3 times a week for 30 minutes each, with electrodes placed at 3 regions of the face corresponding to parotid, submandibular, and sublingual salivery glands.
 

The study was comprised of 35 patients with a mean patient age of 33.56 years (SD = 12.46 years).

MALES 33.7%, FEMALES 66.3%

KEY DISEASE CHARACTERISTICS:  All received conditioning with cyclophosphamide with or without busulfan for HCT. Cyclosporin in combination with methotrexate or mycophenolate mofetil was used for GVHD prophylaxis. All underwent allogeneic HCT. Underlying diseases were bone marrow aplasia, AML, ALL, Hodgkin’s lymphoma, and mantle cell lymphoma. 75% had malignant diseases.
 

SITE: Single site

SETTING TYPE: Inpatient

LOCATION: Brazil

PHASE OF CARE: Active antitumor treatment

 Single, blind, randomized controlled trial

• Salivary collection and analysis and calculation of salivary flow rates over time
• WHO oral mucositis scale
• Salivary cytokine levels
   

Resting salivary flow showed a tendency toward decrease in all patients.  In all therapy groups combined, salivary flow showed less of a decrease than control patients, but this difference was not significant. At the end of the study, the TENS and TENS plus chewing group showed an increase in salivary flow, while the other two groups showed a decline (p < 0.05). Mucositis occurred in 68.5% of patients. There were no differences in grades of mucositis between groups. There was a tendency of lower salivary flow in patients with mucositis of any grade.There were no significant differences seen in salivary TNF and IL-10 levels in relation to occurrence of mucositis.

Electrical salivary stimulation therapy, alone or combined with mechanical chewing therapy appeared to increase salivary flow when compared to chewing therapy alone or no salivary stimulation therapy; however, there was no significant difference seen in mucositis occurrence or severity based on study group or salivary flow.

• Small sample (<100)
• Unintended interventions or applicable interventions not described that would influence results*
• Selective outcomes reporting*
• Measurement/methods were not well described.

Salivary flow decline may contribute to development and severity of oral mucositis. This study shows that electrical stimulation may improve salivary flow. Further research in this are is needed to fully evaluate the effectiveness of salivary stimulation in the management of oral mucositis.