Effectiveness Not Established

Salivary Stimulation

for Mucositis

Salivary stimulation is aimed at preventing functional loss of salivary gland activity. Stimulation can be done mechanically, using chewing gum like stimulation, pharmacologically, or electrically using a transcutaneous electrical nerve stimulation. Salivery stimulation has been studied in patients with cancer for effects on oral mucositis.

Research Evidence Summaries

Didem, A., Ayfer, E., & Ayse Ferda, O. (2014). The effect of chewing gum on oral mucositis in children receiving chemotherapy. Health Science Journal, 8, 373–382.

Study Purpose

To determine if chewing gum is efficacious in the prevention and treatment of oral mucositis in children receiving chemotherapy regimens

Intervention Characteristics/Basic Study Process

Procedure:
  • Permission from institution
  • Written informed consent obtained from parents of each child
  • Interview with parent and child to elicit demographic information
  • The study group consisted of children chewing nonsugary gum for 10 days three times daily for 20 minutes (abstaining from drinking water one hour before chewing gum).
  • Both study groups used Tantum® mouthwash for standard oral care and continued usual tooth brushing.
  • Children’s oral assessments were performed on day s1, 5, and 10 using the World Health Organization (WHO) Oral Mucositis Index (OMI). An Eilers’ Oral Assessment Guide with pH measurements was taken.
  • All assessments were performed by the same researcher.

Sample Characteristics

  • N = 60  
  • AGE RANGE = 6–18 years
  • MALES: 48.33%, FEMALES: 51.7%
  • KEY DISEASE CHARACTERISTICS: Acute myeloid leukemia, acute lymphoblastic leukemia, Hodgkin lymphoma, and Wilms tumor
  • OTHER KEY SAMPLE CHARACTERISTICS: Duration of hospitalization by day, number receiving chemotherapy, and duration of disease by year

Setting

  • SITE: Single site
  • SETTING TYPE: Inpatient pediatric oncology clinic at a university hospital
  • LOCATION: Istanbul

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment
  • APPLICATIONS: Pediatrics

Study Design

Quasi-experimental study with a control group

Measurement Instruments/Methods

  • World Health Organization (WHO) Oral Mucositis Index (OMI)
  • Eilers’ Oral Assessment Guide (EOAG)
  • Intraoral pH assessment measured by researchers within one minute after chewing using pH colormatic strips placed under the tongue for two minutes (values ranged from 4–9)

Results

  • Acute lymphoblastic leukemia was the most common diagnosis.
  • No statistical difference between demographic data in both control and study groups related to age, gender, or educational states was found.
  • At end of the study, significant difference (p < 0.5) in mucositis severity between the two groups existed.
  • At the start of study, the average pH value was 5.8 (SD = 0.6) for the study group and 5.9 (SD = 0.3) for the control group. At end of study (day 10), the average pH value was 6.4 (SD = 0.2) in the study group and 6 (SD = 0.3) in the control group. This was statistically significant (p < 0.5).

Conclusions

Chewing gum was an effective option for preventing and treating oral mucositis in pediatric patients with acute lymphoblastic leukemia, acute myeloid leukemia, Hodgkin lymphoma, and Wilms tumors.

Limitations

  • Small sample (< 100)
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Unintended interventions or applicable interventions not described that would influence results
  • Findings not generalizable
  • Other limitations/explanation: Unintended interventions such as avoiding certain foods or using ice chips at home were not described. Not all children had the same mucositis severity in this study. The type of gum was not described and its ingredients were not described.

Nursing Implications

  • This study indicated a potential treatment and prevention intervention for pediatric patients with cancer.
  • Its findings point to areas for additional nursing research.
  • The intervention was low-cost, accessible, and easy to administer.
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Eghbali, A., Taherkhanchi, B., Bagheri, B., & Sadeghi Sedeh, B. (2016). Effect of chewing gum on oral mucositis in children undergoing chemotherapy: A randomized controlled study. Iranian Journal of Pediatric Hematology and Oncology, 6(1), 9–14.

Study Purpose

To study the effects of salivary stimulation using chewing gum on oral mucositis (OM) in children undergoing chemotherapy

Intervention Characteristics/Basic Study Process

Patients were randomized to a control group or experimental group. Control patients were given a mouth rinse of nystatin, diphenhydramine, and aluminum three times per day. The test group received the same mouth rinse plus sugar-free chewing gum six times per day for 15 days. The gum was chewed for about 30 minutes.

Sample Characteristics

  • N = 130   
  • MEAN AGE = 8.5 years
  • MALES: 50.8%, FEMALES: 49.2%
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: Most had hematologic malignancies.

Setting

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

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment
  • APPLICATIONS: Pediatrics

Study Design

  • Randomized, controlled trial

Measurement Instruments/Methods

  • World Health Organization (WHO) grading system for OM

Results

Prevalence of grade 1 (p < 0.05) and grade 2 (not significant) OM was lower in children who chewed the gum. Grade 3 mucositis was slightly higher among those chewing gum. No difference existed between groups in prevalence of grade 4 mucositis.

Conclusions

Chewing gum for salivary stimulation may help reduce inflammation with low grades of mucositis but shows no overall benefit for more severe mucositis.

Limitations

  • Baseline sample/group differences of import
  • Unintended interventions or applicable interventions not described that would influence results
  • Chemotherapeutic agents used were not described. Adherence to interventions for mouth rinses as well as use of chewing gum are not described.

Nursing Implications

Chewing sugar-free gum to increase salivary stimulation is a low-risk intervention that may help in low-grade mucositis cases but appears to have no overall efficacy in reducing the prevalence or severity of mucositis in children receiving chemotherapy. Further research regarding the potential role of salivary stimulation for the prevention or management of OM would be beneficial.

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Gandemer, V., Le Deley, M., Dollfus, C., Auvrignon, A., Bonnaure-Mallet, M., Duval, M., … Schmitt, C. (2007). Multicenter randomized trial of chewing gum for preventing oral mucositis in children receiving chemotherapy. Journal of Pediatric Hematology/Oncology, 29, 86–94.

Intervention Characteristics/Basic Study Process

Patients chewed five to six pieces of fluoride-containing, sugar-free gum, sweetened with xylitol per day for 20 minutes per piece from the first day of chemotherapy to three days after course of treatment. Both groups practiced standard oral care, consisting of brushing teeth with a soft toothbrush and rinsing with sodium bicarbonate rinse.

Sample Characteristics

  • The study reported on 145 children ages 5–18 years. The gum group had 73 patients, and the control group had 72 patients.
  • All patients were scheduled to receive chemotherapy associated with at least a 30% rate of grade 3–4 oral mucositis according to the World Health Organization (WHO) oral mucositis grading scale.

Setting

The study was conducted between March 1999 and December 2002.

Study Design

This was a randomized, controlled trial.

Measurement Instruments/Methods

Researchers recorded the WHO grade of mucositis within first 21 days, time to development of grade 3–4 mucositis, incidence of any grade of mucositis, incidence of pain using a 70-point visual analogue scale, number of days of total parenteral nutrition, incidence of abdominal symptoms, and incidence of septicemia.

Results

No significant differences were found between arms for severe mucositis endpoints.

Patients receiving less toxic regimens had a decrease in WHO grade 1–4 oral mucositis of 49% in the gum group and 72% in the control group (p = 0.03).
 

Limitations

  • This study did not achieve adequate sample size according to power analysis.
  • Eight children discontinued using the gum because of nausea.
  • Chlorhexidine and fungizone were widely used in both arms.
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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.

Study Purpose

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

Intervention Characteristics/Basic Study Process

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.
 

Sample Characteristics

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.
 

Setting

SITE: Single site

SETTING TYPE: Inpatient

LOCATION: Brazil

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Study Design

 Single, blind, randomized controlled trial

Measurement Instruments/Methods

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

Results

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.

Conclusions

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.

Limitations

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

Nursing Implications

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.

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