Evaluation of oral mucositis, candidiasis, and quality of life in patients with head and neck cancer treated with a hypofractionated or conventional radiotherapy protocol: a longitudinal, prospective, observational study

Study design and participants

This longitudinal, prospective, observational study was conducted in the outpatient support clinic for patients undergoing cancer treatment at the Mario Penna Institute (Belo Horizonte, Minas Gerais, Brazil). All patients assisted between March to December 2021 were invited to participate in the study. This period covers the whole use of hypofractionated RT protocol in the institution.

Participants of both sexes, aged > 18 years with histopathological confirmation of squamous cell carcinoma in the oral cavity, larynx, pharynx, maxillary sinus, and salivary glands with an indication of conventional or hypofractionated RT were included in the study. Exclusion criteria were as follows: patients who continued to consume alcohol and tobacco during RT treatment, patients with an RT regimen different from the study protocols, patients who used a nasogastric tube before RT treatment, and patients who were clinically unable to open their mouths for intraoral evaluation.

A total of 109 patients were included in the study and stratified into two groups:

Conventional protocol group (GConv): Initially composed of 73 participants who underwent a conventional RT protocol consisting of the administration of 5 weekly fractions of 1.8 − 2.0 Gy, with a total of 66 − 70 Gy for 6 − 7 weeks.

Hypofractionated protocol group (GHipo): Initially composed of 36 patients who underwent an RT protocol consisting of the administration of 5 weekly fractions of 2.75 Gy, with a total of 55 Gy for 4 weeks.

For a short period of time, at the most critical moment of the COVID-19 pandemic in Brazil, the Institution implemented the Hypofractionated RT protocol following the recommendations of international guidelines or recent works[16, 17]. Patients belonging to the GHIpo group were selected during this period. After the suspension of the indication of the hypofractionation radiotherapy protocol, a convenient sample was selected from patients submitted to the conventional RT protocol to create a control group (GConv).

Of the total number of participants included, 66 completed all stages of the study, totaling 23 participants for GHipo and 43 for GConv. The remaining participants were excluded due to death, interruption of treatment, refusal to continue in the study, or noncompliance with all stages proposed in the study. The sample calculation considered a prevalence of mucosistis of 61%[18, 19], with 95% confidence. Therefore, the sample would have 92 subjects and considering the loss of up to 30%, the final sample of 66 patients is acceptable.

Oral evaluation of mucositis and candidiasis

The presence and severity of oral mucositis and candidiasis were assessed in all participants at three-time points of the study: i) on the day of the first RT session (initial assessment); ii) halfway through RT treatment (intermediate assessment); and iii) on the day of the last RT session (final assessment). The intermediate evaluation occurred between the 14th and 20th RT sessions for the participants assigned to the GConv and between the 8th and 12th sessions for the GHipo.

Oral mucositis was evaluated according to the methodology proposed by the World Health Organization (WHO), which established the classification criteria to assess this oral mucosa condition [20]. It is a visual and noninvasive evaluation of the oral cavity, where the categorization follows the following parameters: grade 0, no changes; grade 1, pain/erythema; grade 2, erythema and ulcers; grade 3, ulcers (liquid diet only); grade 4, it is not possible to ingest food.

The presence of pseudomembranous candidiasis was clinically evaluated [21]. This evaluation was based on the observation of anatomic localization, features, and removal of the pseudomembrane by rubbing the lesion with gauze, with the adjacent mucosa appearing normal or erythematous, usually painless [21].

Both evaluations were performed on all participants by a single operator with extensive academic training in dentistry and clinical experience, properly trained in all stages proposed to minimize biases related to different perceptions of the oral condition of the participants. In addition to visual evaluation, the participant was also asked about the intensity of pain and difficulty swallowing food.

QoL assessment

QoL was assessed using the questionnaires recommended by the European Organization for Research and Treatment of Cancer, the QLQ-C30 (version 3.0), and QLQ-H&N35 validated for Portuguese [22, 23]. The first assesses the symptoms and QoL of cancer patients in general. It comprises 30 items distributed on scales that measure symptoms and functional aspects commonly related to cancer. Higher scores on the symptom scale represent more/worse symptoms. Conversely, higher scores on the functional scales represent a higher ("better") QoL or a higher level of functioning [24]. The QLQ-H&N35 is a specific module for patients with HNC that must be applied together with the QLQ-C30 questionnaire [23]. This module allows the evaluation of seven specific domains of HNC, namely, pain, swallowing, senses (taste and smell), speech, social eating, social contact, and sexuality. In addition to these, there are 11 specific items on problems, such as dental, trismus, xerostomia, thick saliva, cough, malaise, use of analgesics, nutritional supplements, feeding tubes, and weight loss or gain. Both have items on a 4-point Likert scale (i.e., not at all, 1 point; little, 2 points; moderate, 3 points; and very much, 4 points). The QLQ-C30 questionnaire also has two items on the perception of QoL and health on a 7-point scale (1, very poor; 7, excellent). All scales in both questionnaires are represented by scores ranging from 0 to 100.

The patients answered the two questionnaires in the clinic at two different moments, before the first and after the last RT sessions.

Clinical data and lifestyle research

The patients responded to a structured questionnaire prepared by the researchers to evaluate clinical and sociodemographic conditions and habits such as smoking, alcoholism, and oral hygiene. This questionnaire was applied by the researchers. In addition, patients' medical records were analyzed to collect information related to general health, pre-existing pathologies, medications used, tumor staging and location, and RT and chemotherapy protocols used.

Statistical analysis

Exploratory statistical techniques were used to analyze the data, which allowed for better visualization of the general characteristics of the data. Data were presented in frequency tables with absolute frequencies and their respective percentages and descriptive measures (mean, median, standard deviation, minimum and maximum) for quantitative data. Quantitative variables were tested for normality by the Kolmogorov − Smirnov test. As the continuous variables referring to the QoL questionnaires did not present a normal distribution, non-parametric tests were used (Mann − Whitney test and Wilcoxon test). The categorical variables were compared using the chi-square test, and when they presented expected frequencies below 5, the Fisher's test and the mesh-based Monte Carlo simulation were used for more than two response categories. The significance level adopted in all tests was 5%, therefore, the comparisons with a p-value lower than or equal to 5% were considered significant. The software used for the analyses was SPSS version 25.0.

留言 (0)

沒有登入
gif