Comparison of Two Prophylactic Photobiomodulation Protocols in Chemoinduced Oral Mucositis in Pediatric and Adolescent Oncology Patients: a Randomized, Controlled, Blinded Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Oral mucositis evalution according National Cancer Institute (NCI) scale
研究概览
简要总结
Childhood cancers represent less than 1% of the malignant diseases diagnosed worldwide. Treatment modalities for childhood malignancies will differ depending on the diagnosis. The main treatments may include chemotherapy (QT), radiation therapy (RT), and surgery. The toxicity caused by QT and RT generates adverse effects in the mouth, among them oral mucositis (MO). MO is damage that occurs to the oral mucosa and these lesions are extremely painful, uncomfortable, and cause great morbidity for patients. The main treatment of MO is intraoral photobiomodulation therapy (TBMI), this therapy has been widely used, reducing the severity and pain of MO in patients. The use of extraoral photobiomodulation therapy (TFBME) has been employed in some recent studies and has shown efficacy for reducing and improving the severity of OM. The present study aims to compare the effect of two protocols of photobiomodulation therapy (TFBM) using intraoral and extraoral low power laser in the prevention and treatment of OM in pediatric oncology patients receiving treatment with high dose metrotexate (MTX-HD) and its chemotherapy combinations. Initially, 34 pediatric and adolescent oncology patients receiving intravenous (IV) QT from risk protocols will be selected. Participants will be allocated into 2 groups: Group I: TFBMI (n=17) and Group II: TFBME (n=17). The study will be conducted by a dental surgeon who will perform the initial assessment and reassessments (blinded to the groups) and another who will apply the TFBM. Patients will be evaluated daily from day 1 (D1 - beginning of the chemotherapy cycle) until D10 or until healing of the lesions. The evaluation will consist of oral mucosa examination for grading of OM, pain assessment, quality of life, oral health, depressionand saliva evaluation of patients to assess. The analyses will be performed in the PASW 18.0 program, initially the evaluation of the data distribution will be performed by applying the Shapiro-Wilk and Kolmogorov-Smirnov tests. If, after applying these tests, the data show a normal distribution (p>0.05), the t-test will be used. If the distribution is non-normal after the application of the tests (p<0.05), the Wilcoxon test will be used. The p value will be set at 5%. Logistic regression will be used in adjusted models to estimate the probability of occurrence of OM.
详细描述
The main to compare two TFBM protocols using low-power laser and extraoral high-power laser in preventing OM in pediatric and adolescent oncology patients receiving treatment with antineoplastic chemotherapeutic agents. To evaluate the effectiveness of TFBM using extraoral low-power laser and high-power laser in the prevention and treatment of OM in pediatric patients receiving treatment with MTX-HD chemotherapy and its combinations.
Evaluate the impact of OM on the quality of life, anxiety, depression and pain of these patients. Evaluate the concentration of inflammatory and pro-inflammatory cytokines in saliva using the enzyme-linked immunosorbent assay (ELISA) in individuals undergoing chemotherapy who develop OM. Evaluate the role of NET and TSE in the saliva of patients undergoing chemotherapy who develop OM.
This is a controlled, randomized and blind clinical trial to evaluate the efficacy of the protocol using low-power and extraoral high-power TFBM in the prevention and treatment of OM in pediatric and adolescent oncology patients undergoing different chemotherapy protocols. The study will be conducted at the Hospital de Clínicas de Porto Alegre (HCPA) and AC. Camargo Center in the Pediatric Oncology Sector. After clarification and authorization of the responsible persons, they will have to sign the Informed Consent Form and the able research participants will sign the Informed Consent Form. The project will be registered in the Clinical Trials platform (https://clinicaltrials.gov/) and conducted according to the Consort checklist (Consolidated Standards of Reporting Trials). For data collection and management, the software REDcap® (Research Electronic Data Capture - Vanderbilt University, Nashville - Tennessee) and Google Drive will be used, where all forms regarding the evaluation of patients will be inserted.
A minimum of 34 pediatric and adolescent oncology patients diagnosed with malignancies, receiving intravenous (IV) QT of the following risk protocols for OM or some protocol that these chemotherapy drugs are included, will be included in this study, being: MTX-HD, combination chemotherapy of MTX-HD, doxorubicin and cyclophosphamide; and MTX-HD and cyclophosphamide. Patients who will be invited to participate in this study will be hospitalized for oncologic treatment and the informed consent form (ICF) and the informed consent form (ICF) will be applied at the Pediatric Oncology Department (3rd east) of the Hospital de Clínicas de Porto Alegre (HCPA). All patients included in this study will be submitted to a pre-treatment bedside dental evaluation and, if necessary, oral adaptation procedures (restorative, periodontal or tooth extraction needs) will be performed by the Hospital Dentistry of HCPA, and guidance will be given regarding the use of alcohol-based mouthwash, brushing with soft toothbrush and fluoride toothpaste, as well as guidance on the TFBM protocol and possible oral complications resulting from the QT treatment. All patients will be followed throughout the antineoplastic treatment, receiving reinforcement in oral hygiene orientation and guidance regarding side effects such as OM.
Information on gender (male/female), race, age (in years), medical history, underlying pathology and treatment modality (chemotherapy protocols used), pain medication used (medication category, dose and time of use), nutritional data (whether they are eating orally or using an esophageal tube) will be collected from the electronic medical records. One chemotherapy cycle from each patient included in the study will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcomes assesor will not know the laser protocol of each patient (single blind)
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of malignant neoplasia (hematological or solid tumors);
- •Responsible and participants agree to the study participation after reading and signing the Informed Consent Form (ICF) and Informed Term of Consent (TALE) for participation in Clinical Research;
- •They performed the chemotherapy infusions hospitalized in the pediatric oncology department of the 3rd east of HCPA;
- •Received the following chemotherapy protocols: MTX-HD, combination chemotherapy of MTX-HD, doxorubicin and cyclophosphamide; and MTX-HD and cyclophosphamide.
排除标准
- •Participants will be excluded who:
- •Patients over the age of 18 years
- •Patients who will undergo HSCT
研究组 & 干预措施
Intraoral photobiomodulation (PBMI)
Intraoral application: A low-power laser (Diode Semiconductor, Duo, MMOptics Ltda, São Carlos, SP, Brazil) with a wavelength of 660 nm (red). Four anatomical areas will be irradiated perpendicularly in oral mucosa through several anatomical points with a distance of 1 cm approximately between them in order to cover the largest area per cm² in each region.
Application points:
- Jugal mucosa: 4 points for each side: upper and lower internal buccal vestibule, (8 points).
- Jugal mucosa for younger children 2 points internal buccal vestibule in the center - each side (4 points)
- Tongue: 2 points on right and left lateral border and 1 point on right and left belly (6 points)
- Oral floor: (2 points).
- Upper and lower lips: 2 points on upper inner labial mucosa, 2 points on lower inner labial mucosa (4 points).
- Soft palate: right and left sides (2 points)
干预措施: Diode Semiconductor, Duo (Device)
Extraoral photobiomodulation (PBME)
A gallium-aluminum arsenide diode laser (Gemini® manufactured by Azena Medical, LLC, distributed by Ultradent Products, Inc.) with double wavelength 810 + 980 nm. The equipment will be programmed with 1 W of power.
- 4 points - on each side of the face (2 on the right 2 on the left);
- 2 points - on each side of the face: for younger children 1 point will be performed on each side of the face (1 on the right, 1 on the left)
- 1 point on the lip; patients with sealed lips being able to cover both the upper and lower lip;
- 5 points in the neck region (2 in right submandibular space and 2 in left submandibular space and submental space in the midline).
- 3 points in the neck region for younger children (1 in right submandibular space and 1 in left submandibular space and submental space in the midline)
干预措施: Gemini laser (Device)
结局指标
主要结局
Oral mucositis evalution according National Cancer Institute (NCI) scale
时间窗: 16 months
According to the classification criteria to NCI 1999: Grade 0 None Grade 1 Painless ulcers, erythema or mild pain in the absence of lesions Grade 2 Painful erythema, edema or ulcers but can eat/swallow Grade 3 Painful erythema, edema or ulcers requiring IV hydration Grade 4 Severe ulcerations or requires parenteral/enteral nutrition support or prophylactic intubation
Oral mucositis evalution according World Health Organization (WHO) scale
时间窗: 16 months
According to the classification criteria to World Health Organization (WHO, 1979): Grade 0 None Grade 1 Erythema, oral mucosal tenderness, pain Grade 2 Erythema, ulcerated lesion, can swallow solid food Grade 3 Ulcerated lesions require only liquid diet Grade 4 Impossible to eat, solid or liquid
Oral mucositis Children's International Mucositis Evaluation Scale (CHIMES)
时间窗: 16 months
Childhood Mucositis Evaluation (CHIMES). For the CHIMES- BR version items 1-4 are scored from 0 (best score) to 5 (worst score), the remaining items are answered with yes or no response and are assigned scores of 0 and 1, respectively. The maximum total score is 23.
次要结局
- Quality of Life Assessment(16 months)
- Caregivers' Quality of Life Assessment(16 months)
- Anxiety and depression assessment(16 months)
- Pain evalution The Visual Analogic Scale (VAS)(16 months)
- Analysis NET and TSE(16 months)
- Pain evolution - Wong Baker Faces(16 months)
- Analysis cytokines(16 months)
研究者
Manoela Domingues Martins
Associate Professor
Federal University of Rio Grande do Sul