Randomized Controlled Trial

Authors: Minying Li, Jingjing Zhang, Yawen Zha...

BACKGROUND

This study was to evaluate the predictors of xerostomia and Grade 3 xerostomia in locoregionally advanced nasopharyngeal carcinoma (NPC) patients receiving radical radiotherapy and establish prediction models for xerostomia and Grade 3 xerostomia based on the predictors.

METHODS

Totally, 365 patients with locoregionally advanced NPC who underwent radical radiotherapy were randomly divided into the training set (n = 255) and the testing set (n = 110) at a ratio of 7:3. All variables were included in the least absolute shrinkage and selection operator regression to screen out the potential predictors for xerostomia as well as the Grade 3 xerostomia in locoregionally advanced NPC patients receiving radical radiotherapy. The random forest (RF), a decision tree classifier (DTC), and extreme-gradient boosting (XGB) models were constructed. The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), area under the curve (AUC) and accuracy were analyzed to evaluate the predictive performance of the models.

RESULTS

In the RF model for predicting xerostomia, the sensitivity was 1.000 (95%CI 1.000-1.000), the PPV was 0.990 (95%CI 0.975-1.000), the NPV was 1.000 (95%CI 1.000-1.000), the AUC was 0.999 (95%CI 0.997-1.000) and the accuracy was 0.992 (95%CI 0.981-1.000) in the training set. The sensitivity was 0.933 (95%CI 0.880-0.985), the PPV was 0.933 (95%CI 0.880-0.985), and the AUC was 0.915 (95%CI 0.860-0.970) in the testing set. Hypertension, age, total radiotherapy dose, dose at 50% of the left parotid volume, mean dose to right parotid gland, mean dose to oral cavity, and course of induction chemotherapy were important variables associated with the risk of xerostomia in locoregionally advanced NPC patients receiving radical radiotherapy. The AUC of DTC model for predicting xerostomia was 0.769 (95%CI 0.666-0.872) in the testing set. The AUC of the XGB model for predicting xerostomia was 0.834 (0.753-0.916) in the testing set. The RF model showed the good predictive ability with the AUC of 0.986 (95%CI 0.972-1.000) in the training set, and 0.766 (95%CI 0.626-0.905) in the testing set for identifying patients who at high risk of Grade 3 xerostomia in those with high risk of xerostomia.

CONCLUSIONS

An RF model for predicting xerostomia in locoregionally advanced NPC patients receiving radical radiotherapy and an RF model for predicting Grade 3 xerostomia in those with high risk of xerostomia showed good predictive ability.

Topics: Humans; Nasopharyngeal Carcinoma; Nasopharyngeal Neoplasms; Parotid Gland; Predictive Value of Tests; Radiotherapy, Intensity-Modulated; Xerostomia

PubMed: 35715856
DOI: 10.1186/s12903-022-02269-0

Randomized Controlled Trial

Effects of an integrated supportive program on xerostomia and saliva characteristics in patients with head and neck cancer radiated with a low dose to the major salivary glands: a randomized controlled trial.

Authors: Nan Jiang, Yue Zhao, Malin Stensson...

BACKGROUND

Xerostomia and changes in saliva characteristics are common side-effects in patients with head and neck cancer (HNC) undergoing radiotherapy, which negatively impact their oral health. However, there are no consensus standards for intervention to manage these problems. The aim of this study was to determine the effect of an integrated supportive program on xerostomia and saliva characteristics at a 1-year follow-up of patients with HNC radiated with a low dose to the major salivary glands.

METHODS

The CONSORT guidelines for a randomized controlled trial were used. Participants with a low overall dose to major salivary glands were randomly allocated to an intervention group (n = 47) or a control group (n = 45). The intervention group received usual care and an integrated supportive program, which included three steps: face-to-face education; face-to-face coaching at 1 month post-radiotherapy; and four telephone coaching sessions at 2, 3, 6, and 9 months post-radiotherapy. The face-to-face education consisted of oral hygiene instruction, oral self-care strategies, facial and tongue muscle exercises, and salivary gland massage. Adherence to the intervention was evaluated using a questionnaire completed during the 9 months follow-up. The control group received usual care. The unstimulated saliva flow rate and xerostomia were assessed in both groups.

RESULTS

A total of 79 participants (40 in the intervention group and 39 in the control group) completed the 12 months follow-up. The intervention group achieved significantly greater relief from xerostomia than the control group after 3 months (intervention group: 35.1 ± 5.9 versus control group: 38.0 ± 5.9, P = 0.027) and 12 months follow-up (intervention group: 18.5 ± 4.1 versus control group: 22.8 ± 4.3, P < 0.001). A higher unstimulated saliva flow rate was observed in the intervention group than the control group at 12 months follow-up (intervention group: 0.16 ± 0.08 versus control group: 0.12 ± 0.07, P = 0.035). Adherence to the intervention was generally good.

CONCLUSION

This integrated supportive program with good adherence relieved xerostomia and had a positive effect on unstimulated saliva flow rate among patients with HNC radiated with a low dose to the major salivary glands during the 12 months of follow-up.

TRIAL REGISTRATION

Chinese Clinical Trial Registry ChiCTR2100051876 (08/10/2021), retrospectively registered.

Topics: Head and Neck Neoplasms; Humans; Saliva; Salivary Glands; Surveys and Questionnaires; Xerostomia

PubMed: 35606811
DOI: 10.1186/s12903-022-02225-y

Authors: Ann-Katrin Johansson, Ridwaan Omar, Berit Mastrovito...

OBJECTIVES

To follow the same individuals from age 50 up to 75 years to report on prevalence, persistence, progression, remission, incidence and predictors for xerostomia.

METHODS

A questionnaire was distributed to all 50-years-olds (1992) in two Swedish counties (N = 8888) and repeated at the age of 65 (2007) and 75 years (2017). 3060 individuals responded on all three occasions (response rate 42.5%). Xerostomia was assessed with two questions. Additional questions addressed inter alia general/oral health and oral function.

RESULTS

Reported prevalence of daytime xerostomia were 23.3% and 14.7%, and 39.5% and 27.5% in women and men, age 50 and 75, respectively. Night-time prevalence was higher. At age 50, 27.4% women and 24.0% men reported having dry mouth, and at age 75, 61.0% and 53.8%, respectively. At all time points, women reported significantly more xerostomia than men. Progression (deterioration) was common, and persistence (continuing presence) was high, while 25-year incidence for daytime xerostomia was 16.2% and 12.8%, and 33.6% and 29.8% at night-time, for women and men, respectively. Based on reports at age 50, regression analyses showed that prediction for developing xerostomia during the observation period, and reporting xerostomia at age 75 years, were female gender, impaired general health, chewing, jaw opening and intraoral problems, dissatisfaction with dental appearance, low education and having white/plastic filling.

CONCLUSIONS

Xerostomia is common in older people, especially at night and in women. It can be predicted by diverse factors reported earlier in life.

CLINICAL SIGNIFICANCE

Clinicians need to be made aware of that elderly often suffers from dry mouth so that they can recommend effective measures to eliminate or ease the patients accompanying symptoms and also exclude or lessen possible negative impact on oral health related to xerostomia.

Topics: Age Factors; Aged; Female; Humans; Longitudinal Studies; Male; Middle Aged; Prevalence; Surveys and Questionnaires; Xerostomia

PubMed: 35121136
DOI: 10.1016/j.jdent.2022.104056

Authors: Hitomi Ono Minagi, Yoshie Yamanaka, Kanji Nohara...

OBJECTIVES

To determine the general condition of elderly xerostomia patients, we collected their background and medication data in order to potentially treat their xerostomia. It is critical to identify the drugs causing xerostomia in elderly patients. A total of 521 patients who were examined at the Xerostomia Clinic of Osaka University Dental Hospital were included in the study. We obtained patients' data on age, sex, number of primary illnesses, Saxon test scores, oral moisture test, subjective symptoms, and drug types from their clinical records.

RESULTS

The mean age of the patients was 65.2 ± 13.3 years. Although all patients exhibited xerostomia symptoms, there were a lot of patients without hyposalivation. With respect to medication, each elderly xerostomia patient took an average of 6.8 ± 4.4 medicines. A total of 26.1% of patients in their 70 s took more than ten number of drugs. In addition, the number of frequently used medication medicine was different between elderly and young patients. Most of the medicines had xerostomia as a side effect in medical package inserts. Moreover, the quantity of salivation significantly decreased in patients who took more than seven drugs in comparison with the patients who did not take medicine.

CONCLUSIONS

As patients age, the number of medications they take tends to increase, subsequently increasing their risk of xerostomia. For the health of the patients, it is critical that an accurate diagnosis is made.

CLINICAL RELEVANCE

To establish therapeutic strategies for treatment of xerostomia, this study provides new and important information that will help in the development of xerostomia medical treatment.

Topics: Aged; Humans; Japan; Middle Aged; Salivation; Xerostomia

PubMed: 34581885
DOI: 10.1007/s00784-021-04182-2

Authors: Indre Stankeviciene, Jolanta Aleksejuniene, Alina Puriene...

OBJECTIVE

Xerostomia is a subjective feeling of dry mouth and is commonly observed in patients with autoimmune diseases. Our study examines the association between xerostomia and diet.

MATERIALS AND METHODS

The cross-sectional study includes 1405 adults from 15 Lithuanian geographical areas (52% response rate). A self-reported questionnaire inquired about xerostomia, sex, age, education, residence, and consumption of selected 23 diet items. For the multivariable analysis, 23 diet items were categorized into eight major diet groups. The data were analyzed by bivariate and multivariable analyses.

RESULTS

When comparing participants with and without xerostomia, there were significant differences in consumption frequencies concerning cold-pressed oil ( = 0.013), bread ( = 0.029), processed meat products ( = 0.016), fat and lean fish ( = 0.009), and probiotic supplements ( = 0.002). In the multivariable binary logistic regression model, when controlled for other determinants, the higher consumption of carbohydrates (OR 0.39, 95% CI 0.23-0.65), proteins (OR 0.56, 95% CI 0.32-0.99), and oils (OR 0.58, 95% CI 0.34-1.00) was associated with a lower likelihood of xerostomia.

CONCLUSIONS

The association between xerostomia and the consumption of the six diet items-cold-pressed oils, lean and fat fish, bread, processed meat, and probiotic supplements- and the three major diet groups-carbohydrates, proteins, and oils-was observed. Longitudinal studies are needed to validate the observed associations.

Topics: Aged; Animals; Bread; Cross-Sectional Studies; Diet; Diet Surveys; Diet, Healthy; Dietary Carbohydrates; Dietary Fats, Unsaturated; Dietary Proteins; Female; Fishes; Humans; Lithuania; Logistic Models; Male; Meat Products; Middle Aged; Multivariate Analysis; Odds Ratio; Probiotics; Seafood; Self Report; Xerostomia

PubMed: 34959787
DOI: 10.3390/nu13124235

Authors: Bilge Başakci Çalik, Elif Gür Kabul, Aylin Keskin...

Background/aim

The aim of this study was to assess the reliability and validity of Turkish version of the Xerostomia Inventory XI in patients with primary Sjögren’s syndrome (pSS).

Materials and methods

A cross-sectional survey study design and analysis were used to assess the reliability and validity of the Xerostomia Inventory XI. A total of 69 patients with pSS (5 males, 64 females; mean age = 54.81 ± 8.77 years) were included. The Xerostomia Inventory XI (TR) was applied twice at an interval of 15 days. The test-retest reliability was assessed with the intraclass correlation coefficient (ICC), and the internal consistency of multiitem subscales by calculating Cronbach’s alpha values. The correlations between ESSPRI, basal and stimulated salivary flow (BSF-SSF), Oral Health Impact Profile-14 (OHIP-14) and Oral Health-Related Quality of Life-UK (OHRQoL-UK) Questionnaire were evaluated to determine the construct validity.

Results

The ICC value for test/retest reliability of the Xerostomia Inventory XI (TR) was 0.993. The internal consistency was 0.869. There were low to high correlations between Xerostomia Inventory XI (TR) and ESSPRI, BSF, SSF, OHIR-14 total and OHRQoL-UK total.

Conclusion

The Turkish version of the Xerostomia Inventory XI was found to be clinically valid and reliable to be used in clinical evaluations and rehabilitation interventions in patients with pSS.

Topics: Cross-Sectional Studies; Female; Humans; Male; Middle Aged; Oral Health; Quality of Life; Reproducibility of Results; Sjogren's Syndrome; Surveys and Questionnaires; Translating; Turkey; Xerostomia

PubMed: 34165270
DOI: 10.3906/sag-2005-157

Authors: Indre Stankeviciene, Alina Puriene, Diana Mieliauskaite...

OBJECTIVES

To assess the prevalence and determinants of xerostomia among adults and identify how many of the ones experiencing xerostomia have Sicca and Sjogren's syndromes.

MATERIALS AND METHODS

This cross-sectional study included 1405 35-74-year-old Lithuanians (51.7% response rate) from the five largest Lithuanian cities and 10 peri-urban and rural areas that were randomly selected from each of the 10 Lithuanian counties. Xerostomia was determined by the self-reported experience of dry mouth as "often" or "always". A dentist diagnosed Sicca syndrome by unstimulated whole sialometry and the Schirmer's test, and all cases were referred to a rheumatologist to confirm Sjogren's syndrome. Self-reported questionnaires collected data about the determinants.

RESULTS

The prevalence of xerostomia was 8.0% (n = 112), Sicca syndrome was diagnosed for 8 participants (0.60%), and Sjogren's syndrome for 2 participants (0.14%), with this being the first time it was diagnosed. Experiencing xerostomia was associated with older age (OR 1.7, 95% CI 1.1-2.6), urban residence (OR 3.3, 95% CI 1.6-5.0), presence of systemic diseases (OR 2.5, 95% CI 1.4-3.3), and the use of alcohol (OR 0.6, 95% CI 0.4-0.9). The higher proportion of participants with Sicca syndrome involved females, of older age, having systemic diseases, and using medications.

CONCLUSIONS

The prevalence of xerostomia was 8.0% and the determinants of xerostomia were older age, urban residence, systemic diseases, and absence of using alcohol. In total, 0.6% of participants had Sicca syndrome, which was more prevalent among females, older subjects, those with systematic diseases, and those using medications. Sjogren's syndrome was diagnosed in 0.14% of participants. Clinical relevance Dental clinicians need to be trained to identify potential Sjogren's syndrome cases.

Topics: Adult; Aged; Cross-Sectional Studies; Female; Humans; Self Report; Sjogren's Syndrome; Surveys and Questionnaires; Xerostomia

PubMed: 34706704
DOI: 10.1186/s12903-021-01917-1

Authors: Puja Aggarwal, Katherine A Hutcheson, Robert Yu...

Genetic susceptibility for xerostomia, a common sequela of radiotherapy and chemoradiotherapy for head and neck cancer, is unknown. Therefore, to identify genetic variants associated with moderate to severe xerostomia, we conducted a GWAS of 359 long-term oropharyngeal cancer (OPC) survivors using 579,956 autosomal SNPs. Patient-reported cancer treatment-related xerostomia was assessed using the MD Anderson Symptom Inventory. Patient response was dichotomized as moderate to severe or none to mild symptoms. In our study, 39.2% of OPC survivors reported moderate to severe xerostomia. Our GWAS identified eight SNPs suggestively associated with higher risk of moderate to severe xerostomia in six genomic regions (2p13.3, rs6546481, Minor Allele (MA) = A, ANTXR1, P = 4.3 × 10; 5p13.2-p13.1, rs16903936, MA = G, EGFLAM, P = 5.1 × 10; 4q21.1, rs10518156, MA = G, SHROOM3, P = 7.1 × 10; 19q13.42, rs11882068, MA = G, NLRP9, P = 1.7 × 10; 12q24.33, rs4760542, MA = G, GLT1D1, P = 1.8 × 10; and 3q27.3, rs11714564, MA = G, RTP1, P = 2.9 × 10. Seven SNPs were associated with lower risk of moderate to severe xerostomia, of which only one mapped to specific genomic region (15q21.3, rs4776140, MA = G, LOC105370826, a ncRNA class RNA gene, P = 1.5 × 10). Although our small exploratory study did not reach genome-wide statistical significance, our study provides, for the first time, preliminary evidence of genetic susceptibility to xerostomia. Further studies are needed to elucidate the role of genetic susceptibility to xerostomia.

Topics: Cancer Survivors; Genetic Predisposition to Disease; Head and Neck Neoplasms; Humans; Microfilament Proteins; Oropharyngeal Neoplasms; Patient Reported Outcome Measures; Receptors, Cell Surface; Xerostomia

PubMed: 35459784
DOI: 10.1038/s41598-022-10538-9

Older age, smoking, tooth loss and denture-wearing but neither xerostomia nor salivary gland hypofunction are associated with low intakes of fruit and vegetables in older Danish adults.

Authors: Anne Marie Lynge Pedersen, Anja Weirsøe Dynesen, Berit Lilienthal Heitmann...

Xerostomia and salivary gland hypofunction are prevalent conditions in older people and may adversely influence the intake of certain foods, notably fruit and vegetables. Here, we aimed to investigate whether xerostomia and salivary gland hypofunction were associated with a lower intake of fruit and vegetables. The study included 621 community-dwelling adults, mean age 75⋅2 ± 6⋅4 years, 58⋅9 % female, who had participated in the Copenhagen City Heart Study follow-up, and undergone interviews regarding food intake (preceding month), oral and general health (xerostomia, taste alterations, diseases, medication, alcohol consumption and smoking), clinical oral examination and measurements of unstimulated and chewing-stimulated whole saliva flow rates. The average total energy intake (8⋅4 ± 2⋅7 MJ) and protein energy percentage (14⋅8 ± 3⋅1 %) were slightly below recommendations. The average fruit (234⋅7 ± 201⋅2 g/d) and vegetables (317⋅3 ± 157⋅4 g/d) intakes were within recommendations. Xerostomia and hyposalivation were more prevalent in women than in men (16⋅4 . 7⋅1 %, < 0⋅001 and 40⋅7 27⋅5 %, < 0⋅001). Multiple linear regression analyses revealed that older age ( -0⋅009, se 0⋅003, = 0⋅005), smoking ( -0⋅212, se 0⋅060, = 0⋅0005) and wearing complete dentures/being partially or fully edentulous ( -0⋅141, se 0⋅048, = 0⋅003), but neither xerostomia nor salivary flow rates were associated with an inadequate fruit and vegetable intake, after adjustment for covariates. Older age, smoking, tooth loss and denture-wearing were stronger determinants of low fruit and vegetable intakes than xerostomia and salivary hypofunction supporting the importance of dietary counselling and maintenance of oral health and an adequate masticatory performance.

Topics: Age Factors; Aged; Aged, 80 and over; Denmark; Dentures; Diet; Female; Fruit; Humans; Male; Saliva; Salivary Glands; Smoking; Tooth Loss; Vegetables; Xerostomia

PubMed: 34267893
DOI: 10.1017/jns.2021.38

Randomized Controlled Trial

Authors: Dayaabaran Marimuthu, Kong Min Han, Mohd Shawal Firdaus Mohamad...

OBJECTIVES

Xerostomia is a prevalent sequelae among nasopharyngeal cancer (NPC) survivors; yet, effective treatment protocols have been elusive. This study was a prospective randomized clinical trial to compare the effects of saliva substitute mouthwash in nasopharyngeal cancer survivors with xerostomia, between two treatment arms, conducted in a tertiary center.

MATERIALS AND METHODS

This study measured the effects within 4 weeks in relation to summated xerostomia inventory (SXI) and unstimulated whole saliva (UWS). Patients randomized into the interventional arm were prescribed an immunologically active saliva substitute (IASS), while patients in the control arm were prescribed a non-immunologically active mouthwash as placebo.

RESULTS

The study population consisted of 94 patients. There was a significant difference in SXI difference (p < 0.0001) and UWS difference (p < 0.0001) between control and interventional arms. No harmful side effects associated with the use of either mouthwash encountered throughout the study duration.

CONCLUSION

IASS mouthwash significantly reduces subjective xerostomia scores measured using SXI and improves objective measurement of salivary flow using UWS among nasopharyngeal cancer survivors with xerostomia.

CLINICAL RELEVANCE

IASS is significantly more effective in improving subjective and objective xerostomia measurements compared to non-immunologically active mouthwash. Additionally, this treatment is very safe, with superior side effect profiles.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT04491435.

Topics: Humans; Mouthwashes; Nasopharyngeal Neoplasms; Prospective Studies; Saliva; Survivors; Xerostomia

PubMed: 33175253
DOI: 10.1007/s00784-020-03634-5