Patient-reported Oral Mucositis Research Articles

Patient-reported oral mucositis in solid tumour patients undergoing chemotherapy: a Ugandan experience.

The mitotic rate of the gastrointestinal tract (GIT) mucosa predisposes the entire system to chemotherapeutic-induced mucositis but the oral cavity due to its accessibility provides an opening to evaluate the extent of the problem much more easily. In addition, the oral cavity being the gateway to the GIT affects the feeding ability of the patient when the ulcers set in.It is therefore from this perspective that we embarked on a study to evaluate the extent of mucositis among patients being treated for solid tumours at our centre. Using the mouth and throat soreness (OMDQ MTS) questionnaire, we prospectively evaluated mucositis among 100 patients undergoing chemotherapy for solid tumours at the Uganda Cancer Institute. In addition to patient reported outcomes, we also had clinician assessed mucositis measurements. Approximately, 50% of the participants were breast cancer patients. The results demonstrated that patient assessment of mucositis is possible in our setting at a 76% full compliance rate. Up to 30% of our patients reported moderate-to-severe mucositis, though the figure was lower as assessed by the clinicians. The self-reported OMDQ MTS can be useful in our setting for daily mucositis evaluation, hence leading to timely hospital visits before the manifestation of severe complications.

Randomized Control Study of the Effects of Turmeric Mouthwash on Oral Health Status, Treatment-Induced Mucositis, and Associated Oral Dysfunctions Among Patients With Head and Neck Cancer.

Oral mucositis is the most severe and debilitating adverse effect of cancer treatment, resulting in inadequate nutritional intake, treatment disruptions, and dose alteration, leading to increased hospital costs and decreased tumor control. The aim of this study was to determine the effectiveness of turmeric mouthwash on oral health status and onset and severity of treatment-induced oral mucositis and associated oral dysfunctions among head and neck cancer patients. A randomized controlled design was adopted (CTRI/2018/06/014367). Turmeric mouthwash was administered to the experimental group (n = 46) and benzydamine mouthwash was given to the control group (n = 46). Oral health status and mucositis were graded using the Oral Health Assessment Tool and the World Health Organization oral toxicity criteria, respectively. Oral dysfunctions were measured by a patient-reported oral mucositis symptom scale and xerostomia short-form inventory. All outcome variables were measured weekly during the entire course of radiation therapy. Both groups were comparable with regard to their demographic and outcome variables ( P > .05). The incidence of intolerable mucositis in the control group was 100% compared with 17.8% in the experimental group. Repeated-measures analysis of variance demonstrated significant differences in the onset and severity of oral mucositis ( P = .001), oral health status ( P = .001), and oral dysfunctions ( P = .001) between the experimental and control groups. Turmeric mouthwash was effective in reducing the severity of oral mucositis and associated oral dysfunctions as compared with benzydamine mouthwash. Use of turmeric, a nontoxic and cost-effective intervention, can be an alternative to the traditional management of oral mucositis.

Randomized Phase III, Double Blind, Placebo-Controlled Study of Prophylactic Gabapentin for the Reduction of Oral Mucositis Pain During the Treatment of Oropharyngeal Squamous Cell Carcinoma

<h3>Purpose/Objective(s)</h3> There have been no prior placebo-controlled prospective studies examining the role of gabapentin in HN cancer. We sought to determine if prophylactic gabapentin use in patients undergoing definitive concurrent chemoradiotherapy (chemoRT) for oropharyngeal cancer improves treatment-related pain, patient-reported QOL metrics, opioid analgesic requirements, and feeding tube (FT) placement as compared to placebo. <h3>Materials/Methods</h3> This double-blind, randomized phase III study for patients with AJCC 7^th ed stage III-IV oropharyngeal squamous cell carcinoma undergoing concurrent chemoRT randomly allocated patients to prophylactic gabapentin (600 mg TID) or placebo, stratified by smoking status. This dose was chosen to avoid dose adjustment in the setting of cisplatin-induced nephrotoxicity. All patients received 70 Gy in 35 fractions using IMRT concurrent with a platinum-based regimen. The primary endpoint was change in Patient-Reported Oral Mucositis Symptom (PROMS) scores from baseline to the 6-week post-RT follow-up time point (f/u). Other patient-reported QOL metrics (FACT-HN and PRO-CTCAE), opioid requirements (average over the entire study period and change from baseline, converted to daily morphine equivalents [DME]), and FT placement were assessed. Questionnaires were administered at baseline, weekly during RT treatments, and f/u. Patients were considered compliant if they took at least 12 doses in any given week (patient-reported). Repeated measures ANOVA was used to detect differences in PROMS scores and change in opioid use from baseline. Wilcoxon-rank sum tests were used to compare average opioid use, FACT-HN, and PRO-CTCAE scores. Chi-square test was used to compare FT placement. A <i>p</i>-value less than .05 was considered statistically significant. <h3>Results</h3> There were 65 patients enrolled and 7 withdrew consent, leaving 58 patients analyzed. Baseline characteristics were well-balanced, including stage, type of chemotherapy, and dosimetric parameters. Only 1 patient was non-compliant. All patients completed RT as planned. No significant difference was found in PROMS scores between the two groups at f/u (mean 29.1, SD 22.5, vs 20.1, SD 16.8, for gabapentin vs placebo, respectively, <i>p</i> = .11). The FACT-HN functional well-being index had a significant decrease in scores from baseline to f/u in the gabapentin arm (median -6, IQR -10.0 to -0.5, vs -1, IQR -5.5 to 3.0, <i>p</i> = .03, lower score=worse QOL). PRO-CTCAE scores increased significantly at f/u for gabapentin (median 6.5, IQR 3.5 to 11.8, vs 1, IQR -2.0 to 6.0, <i>p</i> = .01, higher scores worse). There was no significant difference in average or change in opioid use. FT placement was significantly higher in the gabapentin arm (62.1% vs 20.7%, <i>p</i> < .01). <h3>Conclusion</h3> This study suggests that prophylactic gabapentin at 600 mg TID is not effective in improving treatment-related pain in a select group of patients.

Randomized Phase 3, Double-Blind, Placebo-Controlled Study of Prophylactic Gabapentin for the Reduction of Oral Mucositis Pain During the Treatment of Oropharyngeal Squamous Cell Carcinoma

The purpose of this paper is to determine whether prophylactic gabapentin usage in patients undergoing definitive concurrent chemotherapy and radiation therapy (chemoRT) for oropharyngeal cancer (OPC) improves treatment-related oral mucositis pain, opioid use, and feeding tube (FT) placement. This double-blind, randomized phase 3 study for patients with locally advanced OPC undergoing chemoRT randomly allocated patients to prophylactic gabapentin (600 mg thrice daily) or placebo. The primary endpoint was change in Patient-Reported Oral Mucositis Symptom (PROMS) scores over the entire treatment period (baseline to 6 weeks post-radiation therapy [RT] follow-up) with higher scores indicating worse outcomes. Opioid requirements, FT placement, and other patient-reported quality of life (QOL) metrics (Functional Assessment of Cancer Therapy-Head and Neck [FACT-HN] and Patient-Reported Outcomes version of the National Cancer Institute Common Terminology Criteria for Adverse Events [PRO-CTCAE]) were assessed. Lower scores suggested poorer QOL with the FACT-HN questionnaire, and higher scores suggested worse outcomes with the PRO-CTCAE questionnaire. Questionnaires were administered at baseline, weekly during RT, and at 6 weeks post-RT follow-up. Repeated measures analysis of variance was used to detect differences in PROMS scores and change in opioid use from baseline. Wilcoxon rank sum tests were used to compare averages for the other secondary endpoints. A P value less than .05 was considered statistically significant. Treatment arms were well balanced overall, including T and N staging and dosimetric variables. There were 58 patients analyzed. No significant difference was found in PROMS scores (mean 29.1, standard deviation [SD] 22.5 vs 20.1, SD 16.8 for gabapentin vs placebo, respectively, P=.11). The FACT-HN functional well-being index had a significant decrease in scores from baseline to follow-up in the gabapentin arm (median -6, interquartile range [IQR] -10.0 to -0.5 vs -1, IQR -5.5 to 3.0, P=.03). PRO-CTCAE scores increased significantly at follow-up for gabapentin (median 6.5, IQR 3.5-11.8 vs 1, IQR -2.0 to 6.0, P=.01). There was no significant difference in average or change in opioid use. FT placement was significantly higher in the gabapentin arm (62.1% vs 20.7%, P < .01). This study suggests that prophylactic gabapentin is not effective in improving treatment-related oral mucositis symptoms in a select population of patients with OPC undergoing definitive chemoRT.

Randomized Phase III, Double-Blind, Placebo-Controlled Study of Prophylactic Gabapentin for the Reduction of Radiation Therapy-Induced Pain During the Treatment of Oropharyngeal Squamous Cell Carcinoma

<h3>Purpose/Objective(s)</h3> We sought to determine if prophylactic gabapentin usage in patients undergoing definitive concurrent chemoradiotherapy (chemoRT) for oropharyngeal cancer improves patient-reported quality of life (QOL) metrics, opioid analgesic requirements, and feeding tube (FT) placement. <h3>Materials/Methods</h3> This double-blind, randomized phase III study for patients with AJCC 7^th ed stage III-IV oropharyngeal squamous cell carcinoma undergoing concurrent chemoRT randomly allocated patients to prophylactic gabapentin (600 mg TID) or placebo, stratified by smoking status. All patients received 70 Gy in 35 fx using IMRT. The primary endpoint was change in Patient-Reported Oral Mucositis Symptom (PROMS) scores from baseline over the study period. Opioid requirements (average over the entire study period and change from baseline, converted to daily morphine equivalents [DME]), FT placement, and other patient-reported QOL metrics (FACT-HN and PRO-CTCAE) were assessed. Questionnaires were administered at baseline, weekly during RT treatments, and at 6-week post-RT follow-up (f/u). Patients were considered compliant if they took at least 12 doses in any given week (self-reported). Repeated measures ANOVA was used to detect differences in PROMS scores and change in opioid use from baseline. Wilcoxon-rank sum tests were used to compare average opioid use, FACT-HN, and PRO-CTCAE scores. Chi-square test was used to compare FT placement. A <i>P</i> value less than 0.05 was considered statistically significant. <h3>Results</h3> There were 65 patients enrolled in the study and 7 withdrew consent, leaving 58 patients to be analyzed. Baseline characteristics were well-balanced, and only 1 patient was considered non-compliant. All patients completed RT as planned. No significant difference was found in PROMS scores between the two groups (<i>P</i> = 0.130). FT placement was significantly higher in the gabapentin vs placebo arm (64.3% vs 33.3%, <i>P</i> = 0.003). Of the FTs placed, 96% were Dobhoff tubes. There was no significant difference in terms of average opioid use (median 22.8 DME [IQR 12.8-36.5] vs 15.8 DME [IQR 8.3-32.4], <i>P</i> = 0.412) or change in opioid use (<i>P</i> = 0.818) for gabapentin vs placebo, respectively. For the FACT-HN questionnaire, the only significant difference noted was in the functional well-being index with the gabapentin arm having a significant decrease in scores from baseline to f/u (median -6 [IQR -10 to -1.5] vs -1 [IQR -5.75 to 5], <i>P</i> = 0.017) with lower scores suggesting poorer QOL. PRO-CTCAE scores increased significantly at f/u from baseline for gabapentin vs placebo (median 6 [IQR 3 to 11] vs 1 [IQR -2 to 6.5], <i>P</i> = 0.014) with higher scores suggesting worse QOL. <h3>Conclusion</h3> This study suggests that prophylactic gabapentin is not effective in improving pain related to mucositis during chemoRT in patients with oropharyngeal squamous cell carcinoma, and other strategies should be evaluated to minimize opioid usage in this patient population.

Effects of a mucosal coating spray in non-small cell lung cancer patients with nasal mucositis.

e21160 Background: Targeted therapy opens a new era in the treatment of non-small cell lung cancer (NSCLC). At the same time, it also faces a serious problem, that is, the adverse events brought by new drugs, which not only affect the quality of patients’ life, but may even endanger their lives. Nasal mucositis (NM) may cause significant discomfort for the patients, and even result in the interruption of treatment. Episil (mucosal coating spray) oral liquid is a preservative-free oral liquid gel that can be used for the management of pain associated with oral lesions of various etiologies. Our study prospectively assessed effects of mucosal coating spray oral liquid in NSCLC patients with NM. There is no similar studies at home and abroad. Methods: Our study enrolled 15 patients who experience nasal mucositis after targeted therapy (Table). We designed a specific questionnaire according to Oral Mucositis Daily QuestionnaireOMDQ), Oral Mucositis Assessment Scale (OMAS), and the Patient-Reported Oral Mucositis Symptom (PROMS) to evaluate the change of life quality in NSCLC patients. All the patients needed to complete the questionnaire included in the statistical analysis. Evaluations were made before and after 5 treatment days. Results: All the patients were evaluated. Among patients, 87% suffered from NM grade 2 and 33% were with bleeding at study start, quality of life scores improved significantly after 5 treatment days with mucosal coating spray. Only 1 patient’s pain score reduced not that well because of nonstandard medication. No drug-related adverse reactions were found. Conclusions: Mucosal coating spray can effectively improve the nasal mucositis caused by targeted therapy in NSCLC patients. It may provide a new and effective therapy strategy for them, but large sample and additional clinical trials are also needed, especially for bevacizumab as one agent of combination protocol.

Photobiomodulation reduces the impact of radiotherapy on oral health-related quality of life due to mucositis-related symptoms in head and neck cancer patients.

To assess the effectiveness of photobiomodulation therapy (PBMT) in the oral health-related quality of life (OHRQoL) of patients with head and neck cancer undergoing radiotherapy (RT), using the Oral Health Impact Profile-14 (OHIP-14) and the Patient-Reported Oral Mucositis (OM) Symptoms Scale (PROMS), and to correlate OM degree with the PROMS and OHIP-14 scores. Forty-eight patients undergoing RT for head and neck cancer were randomly assigned into two groups: PBMT group (n = 25)-daily PBMT associated with a preventive oral care program (POCP); and control group (n = 23)-receiving POCP exclusively. OHRQoL was assessed using the PROMS and OHIP-14 questionnaires. OM degrees were classified according to the World Health Organization and the National Cancer Institute scales. Assessments were performed at the 1st, 7th, 14th, 21st, and 30th RT sessions. PBMT was effective in preventing and treating severe OM. Both groups showed increased OHRQoL impacts throughout the RT sessions; however, higher impacts were observed in the control group, mainly at the final stage of treatment (21st and 30th RT sessions). Significant correlations were found between the severity of OM and PROMS scores in the total sample and the control group at all RT periods. PROMS and OM scores were positive correlated at 14th, 21st, and 30th RT sessions in the control group, suggesting that this instrument is useful in classifying OM. PBMT was effective in treating and preventing severe OM and OM-related symptoms, and with consequent positive impacts in OHRQoL in head and neck patients undergoing RT. The PROMS scale was helpful instrument for assessment of the severity of OM. Brazilian Clinical Trials database (ReBEC - RBR-5h4y4n), registered in Aug, 24th 2017.

Effect of photobiomodulation on the severity of oral mucositis and molecular changes in head and neck cancer patients undergoing radiotherapy: a study protocol for a cost-effectiveness randomized clinical trial

BackgroundOral mucositis (OM) is the most frequent and debilitating acute side effect associated with head and neck cancer (HNC) treatment. When present, severe OM negatively impacts the quality of life of patients undergoing HNC treatment. Photobiomodulation is a well-consolidated and effective therapy for the treatment and prevention of severe OM, and is associated with a cost reduction of the cancer treatment. Although an increase in the quality of life and a reduction in the severity of OM are well described, there is no study on cost-effectiveness for this approach considering the quality of life as a primary outcome. In addition, little is known about the photobiomodulation effects on salivary inflammatory mediators. Thus, this study aimed to assess the cost-effectiveness of the photobiomodulation therapy for the prevention and control of severe OM and its influence on the salivary inflammatory mediators.Methods/designThis randomized, double-blind clinical trial will include 50 HNC patients undergoing radiotherapy or chemoradiotherapy. The participants will be randomized into two groups: intervention group (photobiomodulation) and control group (preventive oral care protocol). OM (clinical assessment), saliva (assessment of collected samples) and quality of life (Oral Health Impact Profile-14 and Patient-Reported Oral Mucositis Symptoms questionnaires) will be assessed at the 1st, 7th, 14th, 21st and 30th radiotherapy sessions. Oxidative stress and inflammatory cytokine levels will be measured in the saliva samples of all participants. The costs are identified, measured and evaluated considering the radiotherapy time interval. The incremental cost-effectiveness ratio will be estimated. The study will be conducted according to the Brazilian public health system perspective.DiscussionPhotobiomodulation is an effective therapy that reduces the cost associated with OM treatment. However, little is known about its cost-effectiveness, mainly when quality of life is the effectiveness measure. Additionally, this therapy is not supported by the Brazilian public health system. Therefore, this study widens the knowledge about the safety of and strengthens evidence for the use of photobiomodulation therapy, providing information for public policy-makers and also for dental care professionals. This study is strongly encouraged due to its clinical relevance and the possibility of incorporating new technology into public health systems.Trial registrationBrazilian Registry of Clinical Trials—ReBEC, RBR-5h4y4n. Registered on 13 June 2017.

Measurement of oral health quality of life among patients who underwent haematopoietic stem-cell transplantation.

Oral mucositis is a painful condition that occurs in patients who have undergone haematopoietic stem-cell transplantation (HSCT) and has a huge impact on their quality of life. The objective of this study was to examine the extent to which interleukin-6 (IL-6) and tumour necrosis factor alpha (TNF-α) are associated with oral health quality of life among patients who underwent HSCT. A. C. Camargo Cancer Center patients were evaluated over 20 months at 4 different time-points: a) at patient admission (M1); b) on the day of infusion of HSC (M2); c) 12 and 20 days after the first day of the conditioning regimen for autologous and allogeneic transplantation, respectively (M3); and d) 30 days after the first day of the conditioning regimen (M4). Mucositis clinical evaluations were performed using World Health Organization (WHO) criteria. Oral health quality of life was measured using the Oral Health Impact Profile short form (OHIP-14), Oral Mucositis Quality of Life (OMQoL) and Patient-Reported Oral Mucositis Symptom (PROMS) scales. Correlations between clinical data and quality of life scores were examined. STATA 11.0 was used to perform the statistical analyses (5% level of significance). Eighty-two patients participated in the study; 62.2% were male, 28.05% had multiple myeloma, and the mean age was 48.49 years (SD 13.76). Higher scores (worse quality of life) were observed as mucositis scores increased, but the results were not significant. The OMQoL had a high correlation with OHIP-14 (0.8377), but the correlation between the PROMS scale and the OHIP-14 was lower (0.6643). Higher concentrations of IL-6 and TNF-α were associated with worse quality of life, according to all indices (p < 0.05). Oral mucositis was associated with quality of life scores (p < 0.01).

Actual duration of patient-reported mucositis: Far longer than 2 to 4 weeks and may be avoidable altogether

The impression that oral mucositis is a brief 14–28 day-consequence of chemoradiation is misguided. Clinically significant patient-reported oral mucositis may last 46 to 102 days depending on the treatment schedule and the modality used. The process of mucositis can occur in the epithelium throughout the entire GI tract and may possibly be avoided with the prescribed use of high potency polymerized cross-linked sucralfate (HPPCLS). Literature review of patient-reported mucositis occuring in the three common schedules of cancer treatment administration: daily radiation therapy, induction-based hematopoietic stem cell transplantation (HSCT), and multi-cycle chemo/immunotherapy (CT-IT). Review articles published in last 15 years focused on treatment-induced oral mucositis. The author reviewed 56 articles published in 15 years from 1999–2014 that focused primarily on treatment-induced oral mucositis. Only 6 were found to meet the criteria of providing patient-reported data from the beginning, throughout and following cancer treatment. For HSCT, radiation therapy, and CT-IT, despite active anti-mucositis treatment, patient-reported oral mucositis lasted 46–60 days, 70–84 days, and 68–102 days, respectively. Mucositis caused by cancer treatment, regardless of modality, lasts far longer than the oft quoted 2–4 weeks (range, 14–28 days). Patient reported mucositis persists from 46 to 102 days. This patient-based experience is the primary cause of treatment interruptions, delays or cancellations. It may be avoidable with HPPCLS that both prevents and rapidly reverses mucositis anywhere it occurs within the gastrointestinal tract.

Quality of life related to oral mucositis of patients undergoing haematopoietic stem cell transplantation and receiving specialised oral care with low-level laser therapy: a prospective observational study.

Oral mucositis is a painful condition that occurs in 80% of patients who undergo haematopoietic stem cell transplantation (HSCT). Our objective was to determine the impact of mucositis on quality of life (QoL) of patients subjected to HSCT treated with low-level laser therapy (LLLT). Patients were evaluated: (1) on the first day of treatment; (2) 5days after autologous or 8days after allogeneic transplantation; (3) once bone marrow had integrated; and (4) 30days after discharge. Clinical evaluation was performed using the World Health Organization criteria; oral health QoL was measured using the Oral Health Impact Profile (OHIP-14); and mucositis symptoms with the Patient-Reported Oral Mucositis Symptom (PROMS) scale. The higher the score, the lower the patient's QoL. The OHIP-14 responses showed that at D+5/D+8, all domains had the highest scores, while at times 1 and 4, the scores were lower. In the PROMS scale, all domains scored worst at time 2, and the differences between the scores at the four times were statistically significant. The study has shown that QoL improves over time in patients undergoing LLLT therapy for mucositis prevention.

Symptoms Reported by Head and Neck Cancer Patients during Radiotherapy and Association with Mucosal Ulceration Site and Size: An Observational Study.

BackgroundSelf-reported pain and impairment of oral functions varies markedly and often in spite of extensive oral mucositis (OM). The aim of the current study was to appraise how patient-reported debilitation caused by OM is influenced by the extent and possibly location of the OM lesions.MethodsPatients with head and neck cancer undergoing radiotherapy were examined before treatment, twice weekly during 6-7 weeks of therapy, and 3-4 weeks after therapy completion. OM signs of 33 participants were evaluated using the Oral Mucositis Assessment Scale (OMAS), while OM symptoms were recorded using Patient-Reported Oral Mucositis Symptom (PROMS)-questionnaires. Changes in OM experience as a function of OM signs was undertaken by comparing the aggregated and individual PROMS scale values at the point of transition of OMAS ulceration scores between 0 to 1, 1 to 2 and 2 to 3, respectively in the nine intra-oral locations designated in the OMAS. ANOVA with pairwise contrasts using the LSD procedure was applied for comparisons of mean changes of PROMS scale values for the participants who experienced an OMAS score of 2 or more during therapy (n=24).ResultsImpairment of eating hard foods was more when the OMAS score for ulceration anywhere in the mouth or in the soft palate changed from 1 to 2, compared to between score 0 and 1 (p=.002 and p=.05) or between score 2 and 3 (p=.001 and p=.02). Mouth pain increased more upon transition of OMAS score anywhere in the mouth from 1 to 2 compared to 0 to 1 (p=.05).ConclusionThe relationship between patient-reported impairment of oral function and pain caused by OM ulceration is not linear, but rather curvilinear. Our findings should prompt investigators of future interventional trials to consider using a less severe outcome than maximum OM scores as the primary study outcome.

Assessment of Cancer Therapy-Induced Oral Mucositis Using a Patient-Reported Oral Mucositis Experience Questionnaire

ObjectivesTreatment of oral mucositis (OM) is challenging. In order to develop and test useful treatment approaches, the development of reliable, reproducible and simpler methods than are currently available for assessment of OM is important. A Patient-Reported Oral Mucositis Symptom (PROMS) scale was assessed in patients with head and neck cancer to determine if the patient-reported OM experience, as determined by using the PROMS scale, correlate with OM assessed by clinician-based scoring tools.Materials and MethodsFifty patients with head and neck cancer and undergoing radiotherapy consented to participate. They were examined before cancer treatment and twice weekly during 6–7 weeks of therapy and once 4–6 weeks after therapy. Signs of OM were evaluated using the 3 clinician-based scoring tools; NCI-CTCAE v.3, the OMAS criteria and the Total VAS-OMAS. The participants' OM experiences were recorded using PROMS-questionnaires consisting of 10 questions on a visual analogue scale. Spearman rank correlation test were applied between the PROMS scale values and the clinician-determined scores. Repeated measures mixed linear models were applied to appraise the strengths of correlation at the different time points throughout the observation period.ResultsThirty-three participants completed all stages of the study. The participant experience of OM using the PROMS scale demonstrates good correlations (Spearman's Rho 0.65–0.78, p<0.001) with the clinician-determined scores on the group level over all time points and poor to good correlations (Spearman's Rho -0.12–0.70, p<0.001) on the group level at different time points during and after therapy. When mouth opening was problematic, i.e. during the 6th and 7th week after commencing cancer treatment, the Spearman's Rho varied between 0.19 and 0.70 (p<0.001).ConclusionPatient experience of OM, as reported by the PROMS scale may be a feasible substitute for clinical assessment in situations where patients cannot endure oral examinations.

Sodium Bicarbonate Solution versus Chlorhexidine Mouthwash in Oral Care of Acute Leukemia Patients Undergoing Induction Chemotherapy: A Randomized Controlled Trial

The objective of this study was to compare the effectiveness of sodium bicarbonate (SB) solution with chlorhexidine (CHX) mouthwash in oral care of acute leukemia patients under induction chemotherapy. Forty-eight patients were randomly selected and assigned to an SB solution group or CHX-based product group according to acute myelogenous leukemia or acute lymphoblastic leukemia. Patients were asked to rinse their mouth four times a day from the day before chemotherapy started until discharge. The World Health Organization mucositis grade, patient-reported Oral Mucositis Daily Questionnaire, and clinical signs associated with infection were assessed on a daily basis. The oral microbial count was assessed on a weekly basis from the 1st day of chemotherapy started to the 28th day or to the day of discharge from the hospital. Of all the patients in the SB group, 25.0% developed ulcerative oral mucositis, whereas 62.5% in the CHX group did. The onset of oral mucositis was later in the SB group than the CHX group. The oral bacterial colonization in the SB group was significantly higher than that in the CHX group, but clinical signs associated with infection did not differ in both groups. As a result of this study, it was found that oral care by SB solution for acute leukemia patients undergoing chemotherapy was an effective intervention to improve oral health.

Prospective evaluation of oral mucositis in solid tumor patients undergoing chemotherapy and its clinical implication

e20650 Background: Oral mucositis (OM) induced by chemotherapy is a troublesome and debilitating adverse effect in solid tumor patients. OM might influence the complicated aspects such as the poor oral intake and malnutrition over just oral symptom. Therefore we prospectively evaluated the actual incidence of OM and its clinical significance in solid tumor patients. Methods: From October 16, 2007 to September 3, 2008, we consecutively enrolled 344 patients with solid tumor who initiated new chemotherapy. Each patient was prospectively evaluated for two cycles. The data were collected from physician-to-patient interview. And patients’ diary for OM symptom was used as patient-reported measurement. The visual analog scale (VAS) was used to quantify the degree of adverse effects (VAS: 0 point = no symptoms, 4 point = the worst symptom) and FACT-G was used for assessment of the quality of life (QOL). Results: Finally, 322 patients were analyzed. The median age was 51. Breast cancer was the most common (51%). And, stage IV was 137 (43%). OM was 28% per each cycle and 45% per patient during two cycles. Patient-reported OM symptom had peak in one week and was recovered in 9.14±6.77 days. Oral dryness was the most prevalent symptom out of symptoms related with OM such as oral pain, poor oral intake, dysphagia, oral bleeding, scalloping of tongue and ulceration (VAS score 1≤; 47%, 27%, 39%, 15%, 7%, 14%, 13%, respectively). In QOL measured by FACT-G, physical well-being and emotional well-being were significantly dropped in OM-occurred group than in no-OM group (19.09±6.48 vs 22.47±5.95, p&lt;0.001; 16.74±4.10 vs 17.97±3.38, P&lt;0.001, respectively). In addition, higher VAS score for other adverse effects was showed in OM-occurred group than in no-OM group (activity, nausea, vomiting, fever, myalgia and nervous system; p=0.0038, p&lt;0.0001, p=0.0007, p=0.0062, p&lt;0.0001, p&lt;0.0001, respectively). Conclusions: Forty five percent of patients with solid tumor experience OM during 2 cycles of chemotherapy. In case of patients with OM, QOL is worse and the other adverse effects are more prevalent. OM could be an indicator of QOL and other adverse effects during chemotherapy. No significant financial relationships to disclose.