A randomized clinical trial of granulocyte macrophage colony stimulating factor mouthwash for oral mucositis in head and neck cancer.

PURPOSE: Oral mucositis (OM) is a significant problem for patients with head and neck cancer (HNC). The purpose of this double-blind, randomized clinical trial (RCT) was to evaluate the effectiveness of the granulocyte macrophage colony stimulating factor (GM-CSF) mouthwash compared to Salt and Soda mouthwash for both the prevention (prior to onset of OM) and treatment (beginning at the onset of OM to its healing) of radiation therapy (RT)-induced OM. METHODS: A total of 91 patients with HNC were randomized to receive: GM-CSF throughout both the prevention and treatment phases (GG group); Salt and Soda throughout both phases (SS group) or Salt and Soda during the prevention phase followed by GM-CSF at the onset of OM (SG group). Three groups were compared on the occurrence and grades of OM, functional status, pain, chewing, and swallowing during and after RT. RESULTS: No significant differences were found in the occurrence and grades of OM in the patients who used GM-CSF vs. Salt and Soda in the prevention phase. In addition, no differences were seen among the three groups in functional status, pain, chewing, and swallowing during and after RT. CONCLUSION: Given that GM-CSF was no more effective than Salt and Soda mouthwash for the prevention or treatment of OM, the readily available and cheaper mouthwash can be used at considerable cost savings.

Designing and Evaluating an Interprofessional Practice Experience Involving Dental and Pharmacy Students.

Objective. To prepare pharmacy and dental students to collaborate as members of an interprofessional team by participating in an interprofessional practice experience. Methods. An interprofessional practice experience was implemented within a dental admissions clinic. Pharmacy and dental students collaboratively conducted medical histories and provided tobacco cessation education. Pharmacy student performance was measured using a standardized assessment rubric; pharmacy and dental student perceptions were measured using the SPICE-R tool; and faculty feedback was captured for evaluation purposes. Results. Pharmacy students achieved performance expectations upon completion. There was a statistically significant increase in the mean scores for a majority of the SPICE-R factors for pharmacy and dental students. Overall, faculty perceptions of the practice experience were positive. Conclusion. A collaboration between pharmacy and dental schools is a novel approach to meeting interprofessional and experiential curricular goals. Evaluating performance in practice experiences and perceptions can be used to demonstrate learner outcomes within interprofessional education. Furthermore, faculty feedback should be used to improve practice experiences.

Self-care intervention to reduce oral candidiasis recurrences in HIV-seropositive persons: a pilot study.

OBJECTIVES: This single-blind randomized controlled pilot study evaluated the efficacy of a behavioral intervention program, PRO-SELF: Candidiasis, to reduce time to recurrence of oral candidiasis over 6 months in susceptible HIV-seropositive persons. The intervention involved instruction by dentists on improving oral hygiene, minimizing sugar intake, and self-diagnosing candidiasis. METHODS: Participants were adults with oral candidiasis responsive to antifungals who presented to the UCSF Stomatology Clinic between 1997 and 2000. At 2-3 weeks of follow-up visits, a dentist "examiner", masked to group assignment, quizzed participants as to the presence of candidiasis, and assessed candidiasis status. A second, unmasked dentist "instructor" then delivered the program to intervention participants. Participants recorded dietary and oral hygiene practices in 24-h recall diaries: intervention participants at each visit and controls at initial and final visits. RESULTS: At randomization, CD4+ cell counts (cells/mm(3)) were 298 +/- 188 among 18 intervention participants and 396 +/- 228 among 17 controls. The candidiasis recurrence rates at 6 months were 78% among intervention compared with 88% among control participants (hazard ratio 0.72; 95% CI 0.35-1.50). Performing oral hygiene after meals/snacks showed the largest relative improvement: intervention-control difference in proportion of meals/snacks affected was 24% (95% CI -1 to 48%). Self-diagnoses of candidiasis were inaccurate, possibly because of mild episodes. CONCLUSIONS: The results weakly indicate that regular instruction from healthcare professionals helps patients delay candidiasis recurrence by improving oral hygiene. Among HIV-seropositive persons, those with poor oral hygiene, and high-sugar diets are most likely to benefit.

Mechanisms for radiation-induced oral mucositis and the consequences.

Radiation therapy remains the primary method of treatment for patients with head and neck cancer. The tissue destruction and functional alterations in the oral cavity lead to the development of oral mucositis. The purpose of this review is to describe the mechanisms, risk factors, prevalence, and magnitude of radiation therapy-related oral mucositis and its morbidities in patients with head and neck cancer. The review concludes with a discussion of the implications for clinical practice. This review provides cancer nurses with the information necessary to identify patients with head and neck cancer who are at high risk for oral mucositis and the significant comorbidities associated with this complication of radiation therapy.

Radiation-induced mucositis: a randomized clinical trial of micronized sucralfate versus salt & soda mouthwashes.

Oral mucositis is one of the major toxicities caused by radiation therapy (RT) treatments to the head and neck. The clinical efficacy of sucralfate (Carafate R) mouthwash for head and neck cancer patients (HNC) is not consistent across studies. In this study, it was hypothesized that if the particles in the original sucralfate suspension were micronized (i.e., < or = 25 microns) then the coating action of the mouthwash in the oral cavity would be enhanced. The purpose of this pilot study was to compare the efficacy of micronized sucralfate (Carafate R) mouthwash and salt & soda mouthwash in terms of the severity of the mucositis, the severity of mucositis-related pain, and the time required to heal RT-induced mucositis in patients with HNC. Severe mucositis and related pain can interfere with the ingestion of food and fluids, so patients' body weights were measured as well. All patients in this randomized clinical trial carried out a systematic oral hygiene protocol called the PRO-SELF: Mouth Aware (PSMA) Program. Patients who developed RT-induced mucositis anytime during their course of RT were randomized to one of the two mouthwashes and followed to the completion of RT and at one month following RT. Two referral sites were used for the study. Repeated measures occurred with the following instruments/variables: MacDibbs Mouth Assessment and weight. Demographic, disease, and cancer treatment information was also obtained. Thirty patients successfully completed the study. The typical participant was male (70%), married/partnered (70%), White (63%), not working or retired (73%), and had an average of 14.5 years of education (SD = 3.7). T-tests and Chi-square analyses with an alpha set at 0.05 were used to compare differences between the two mouthwashes. No significant differences were found in the number of days to onset of mucositis (i.e., 16 +/- 8.4 days). When patients had their worst MacDibbs score, (i.e., the most severe mucositis), there were no significant differences between the mouthwashes as to MacDibbs score, the RT dose received, or ratings of pain (upon swallowing). Similarly, at the end of RT, no significant differences were found between mouthwashes as to MacDibbs scores or ratings of pain (upon swallowing). At the one-month follow-up assessment no significant differences were found between the mouthwashes in MacDibbs scores or pain ratings (upon swallowing). The analysis of the efficacy of the two mouthwashes revealed no significant differences in the time to heal (in days) from the RT-induced mucositis. The findings from this trial provide important clinical information regarding cost analysis of RT mucositis management. Given that there is no significant difference in efficacy between micronized sucralfate and salt & soda, use of the less costly salt & soda is prudent and cost-effective.

A research review of the current treatments for radiation-induced oral mucositis in patients with head and neck cancer.

PURPOSE/OBJECTIVES: To review the research studies on the current treatments for radiation therapy-(RT-) induced mucositis in patients with head and neck cancer. DATA SOURCES: MEDLINE search of the literature from 1966-2001. DATA SYNTHESIS: Four types of agents (i.e., antimicrobial, coating, anti-inflammatory, and cytokine-like agents) have been evaluated for the management of RT-induced oral mucositis in patients with head and neck cancer. Most of the published studies had relatively small sample sizes and used inconsistent measures to evaluate the extent and severity of oral mucositis. Therefore, definitive conclusions regarding the effectiveness of any of the agents tested in the prevention and treatment of RT-induced oral mucositis cannot be drawn. CONCLUSIONS: Oral mucositis remains the most common complication among patients with head and neck cancer. Although a number of strategies and products are being investigated and new directions are promising, the therapies tested to date have not produced consistent results. IMPLICATIONS FOR NURSING: The most effective measure to treat RT-induced mucositis in patients with head and neck cancer is frequent oral rinsing with a bland mouthwash, such as saline or a sodium bicarbonate rinse, to reduce the amount of oral microbial flora. Dental care, consistent oral assessments, and the initiation of a standardized oral hygiene protocol before the initiation of cancer treatment are the most effective approaches for oral mucositis.

Differences in risk factors among clinical types of oral candidiasis in the Women's Interagency HIV Study.

OBJECTIVES: The purpose of this study was to determine the prevalence and concurrence/associations of oral candidiasis types and multiple risk factors in women. STUDY DESIGN: A cross-sectional analysis of baseline data for 577 human immunodeficiency virus (HIV)-seropositive and 152 HIV-seronegative women from the Women's Interagency HIV Study was conducted. Pseudomembranous candidiasis (PC) and erythematous (EC) candidiasis, angular cheilitis (AC), and denture stomatitis (DS) were studied, and bivariate and multivariate regression analyses were performed. RESULTS: Prevalences were 8% for PC, 7% for EC, 18% for DS, and 3% for AC; all except AC usually occurred alone. HIV seropositivity was associated with PC, EC, and DS, but not AC. Among HIV-seropositive women, low CD4 cell counts were associated with PC, but not with EC or DS. Heroin/methadone use was associated with PC and EC; salivary hypofunction was associated with PC; high viral load was associated with EC, and poor oral hygiene, with EC and DS. CONCLUSIONS: Risk factors varied among candidiasis types, suggesting differences in pathogenic mechanisms and usefulness as markers of HIV infection/progression.