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Showing 1-20 of 66 trials
NCT07538934
This is a prospective, open-label, randomized, controlled, multicenter phase II study evaluating the efficacy and safety of Kangfu Spray for the prevention of radiation-induced oral mucositis in patients with histologically confirmed oral malignancies receiving intensity-modulated radiotherapy (IMRT), with or without concurrent platinum-based chemotherapy. Eligible participants will undergo definitive or postoperative adjuvant IMRT according to multidisciplinary team recommendations. Participants in the experimental group will receive Kangfu Spray prophylactically from the first day of radiotherapy until completion of radiotherapy, in addition to standard oral care. The primary endpoint is the incidence of severe radiation-induced oral mucositis, defined as World Health Organization (WHO) grade 3 or higher. Secondary endpoints include time to onset and duration of severe oral mucositis, incidence and duration of any oral mucositis, oral ulcer and pain scores, radiotherapy interruption, opioid analgesic use, nutritional indicators, quality of life, and safety. Exploratory analyses will evaluate lymphocytes, inflammatory factors, and microbiota in blood and saliva.
NCT06708702
Oral mucositis is the most significant acute toxicity of oral cavity radiotherapy. The available scientific evidence supports its preventive and therapeutic approach with low-level laser; however, this is unsuitable for tumor regions due to the risk of stimulating cellular metabolism. In this sense, an alternative treatment becomes necessary. Based on the preliminary results of the phase I study, a double-blind, randomized phase II study is suggested to evaluate the effectiveness of copaiba-based mouthwash in the prevention of oral mucositis in patients undergoing radiotherapy for oral cavity tumors. Patients will be randomized into 2 groups: A (copaíba) and B (placebo) and will use the mouthwash 4x/day. Each group will have 20 patients and be blind to the group in which they are included. They will be evaluated daily by a dental surgeon about oral mucositis, pain in the oral cavity and oropharynx, and dysphagia and will undergo daily laser therapy sessions, until the end of radiotherapy.
NCT07282483
Evaluate the efficacy and safety of traditional Chinese medicine oral liquid and mouthwash in the treatment of radiotherapy induced oral mucositis in patients with head and neck malignancies
NCT07339774
Evaluate the effectiveness and safety of traditional Chinese medicine compound in improving radiotherapy-induced oral mucositis in patients with head and neck malignant tumors.
NCT05853692
Oral Mucositis (OM) consists in the painful inflammation and ulceration of the mucous membranes lining the digestive tract, lasting between 7 and 98 days; and starts as an acute inflammation of oral mucosa, tongue, and pharynx after RT exposure. Gel X spray is a product based on zinc gluconate. It could be helpful to achieve the prevention of Oral Mucositis and, in case of OM manifestation, the reduction of oral pain symptoms and to accelerate the healing process of oral mucositis ulcerations. The aim of this study is to demonstrate the efficacy of the treatment with Gel X to reduce the incidence of oral mucositis, in comparison with Sodium Bicarbonate.
NCT07467759
This single-center, open-label, randomized clinical trial evaluates the effect of 0.15% benzydamine hydrochloride (Difflam) oral spray on the severity of radiation-induced oral mucositis in patients with head and neck cancer receiving high-dose radiotherapy (≥50 Gy) without concurrent chemotherapy. Oral mucositis is a common and clinically significant complication of radiotherapy that can cause pain, difficulty swallowing, nutritional impairment, and treatment interruption. Participants are randomly assigned to receive either standard oral care alone or standard oral care plus benzydamine oral spray for 6 weeks. Oral mucositis severity is assessed weekly using the World Health Organization (WHO) oral mucositis grading scale. The study aims to determine whether benzydamine reduces the progression and severity of oral mucositis in this patient population.
NCT07287826
The goal of this clinical trial is to learn if a steroid mouthwash (dexamethasone) can prevent mouth sores caused by chemotherapy in adults with cancer. The main questions it aims to answer are: Does using dexamethasone mouthwash before and during chemotherapy lower the chance of getting moderate to severe mouth sores? Can this approach reduce pain and improve comfort during chemotherapy? Researchers will compare patients using the mouthwash to a historical group of patients who received similar chemotherapy but did not use the mouthwash, to see if the mouthwash helps prevent mouth sores. Participants will: Use a steroid mouthwash (4 times daily) for up to 8 weeks during chemotherapy Complete a short weekly survey about mouth discomfort during infusion visits
NCT07372443
Oral mucositis (OM) is a frequent, debilitating complication in pediatric oncology that impairs quality of life, nutrition, hydration, and treatment adherence. This randomized, prospective, single blind trial in Mexico will evaluate photobiomodulation (PBM) versus a conventional bioadhesive gel for prevention and treatment of antineoplastic therapy-induced OM in children aged 4-17 with leukemia, lymphoma, or head and neck tumors. A total of 49 participants will be enrolled. The study has two components: (1) Treatment - parallel comparison of PBM versus bioadhesive gel for established OM; (2) Prevention - crossover design in which patients receive both interventions across successive chemotherapy cycles. PBM will be delivered with a 660 nm device, 40 mW, 10 J/cm². The primary outcome is OM grade by the WHO scale assessed on days 7, 11, 14, and 21. Expected results include reduced OM incidence, severity, duration, and pain with favorable safety and tolerability, supporting standardized PBM protocols in pediatric oncology in Mexico.
NCT07247799
The present study aims to evaluate the effectiveness of a combined protocol of professional and at-home ozone therapy in the treatment of oral mucositis in patients undergoing radio- and/or chemotherapy. In-office treatment was performed using a medical ozone generator, while at-home therapy involved the daily application of high-concentration ozonated oil products. The study assessed the reduction in mucositis severity (WHO scale), decrease in pain (VAS scale), and improvement in patient-reported quality of life, with specific attention to nutrition, oral hygiene, and treatment adherence.
NCT07327476
The goal of this randomized controlled clinical trial is to determine whether oral cryotherapy using ice chips can prevent and reduce the incidence and severity of chemotherapy-induced oral mucositis in adult cancer patients receiving 5-fluorouracil and methotrexate chemotherapy regimens. The main questions it aims to answer are: Does the application of oral ice chips reduce the severity of oral mucositis compared to routine mouth care alone? Is there a significant difference in oral mucositis grades between patients receiving oral cryotherapy and those receiving standard mouthwash care? Researchers will compare the experimental group receiving oral ice chips during chemotherapy plus routine mouthwash care with the control group receiving routine mouthwash care only to evaluate the effectiveness of oral cryotherapy in reducing oral mucositis severity. Participants will: Be randomly assigned to either the experimental group (n = 51) or control group (n = 51) Receive chemotherapy with 5-fluorouracil or methotrexate Use routine mouthwash (normal saline/sodium bicarbonate/chlorhexidine) at home Receive oral ice chips during chemotherapy infusion (experimental group only) Be assessed for oral mucositis severity using the WHO Oral Mucositis Grading Scale before and after the intervention
NCT05635929
The use of a novel topical mucosa composition (XCM-OM118) comprising 2-(trimethylazaniumyl) acetate; (2R,3R,4S)-pentane-1,2,3,4,5-pentol; Hexadecanoic acid; (9Z, 12Z)-octadeca-9,12-dienoic acid; octadecanoic acid; (Z)-hexadec-9-enoic acid; (Z)-octadec-9-enoic acid) delivered as a gel and a mouthwash is to be studied in regard to its effect on the incidence of severe oral mucositis in Head \& Neck cancer radiated patients. Patient reported outcome measures seem to be an effective tool to obtain a greater knowledge of the physical and emotional state of patients, being used in this study to assess quality of life of Head \& Neck cancer radiated patients.
NCT07312656
Radiation-induced oral mucositis (RIOM) is an inevitable acute complication in radiotherapy for head and neck malignancies, characterized by a complex pathogenesis involving multiple biological processes. According to the latest data from the International Agency for Research on Cancer (IARC), approximately 650,000 new cases of head and neck cancers are diagnosed globally each year, with about 70% of patients undergoing radiotherapy. RIOM develops through a multistep pathophysiological cascade, including initiation of mucosal injury, signaling amplification, inflammatory response, ulceration, and eventual healing. Ionizing radiation induces DNA damage in oral mucosal epithelial cells, triggering increased apoptosis. This cellular injury promotes the activation and release of pro-inflammatory mediators such as tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β), and interleukin-6 (IL-6), compromising the integrity of the mucosal barrier and ultimately leading to ulcer formation. Current clinical management of RIOM remains largely supportive, relying on oral hygiene, nutritional supplementation, and pain control, with no effective prophylactic agents available. Despite extensive research into potential interventions internationally, no drugs specifically approved by the FDA or NMPA for the prevention of RIOM have reached the market. This significant unmet clinical need calls for urgent scientific and therapeutic advancement. This study aims to evaluate the therapeutic efficacy and safety profile of aerosolized exosomes derived from mesenchymal stem cells in the prevention and treatment of radiation-induced oral mucositis in patients receiving radiotherapy for head and neck cancers. The ultimate objective is to establish a novel and effective therapeutic strategy for clinical application.
NCT07040969
To evaluate the efficacy and safety of Spirulina-Derived Product for prevention and treatment of oral mucositis in patients undergoing radiotherapy for malignant head and neck tumors.
NCT07297472
the Objectives of this clinical trial is : 1. To determine the effect of Cold Application for preventing of chemotherapy-Induced oral mucositis in cancer patients. 2. To examine the effect of artificial saliva for preventing of chemotherapy-Induced oral mucositis in cancer patients. 3. To compare between the effect of artificial saliva and cold application for preventing of chemotherapy-Induced oral mucositis in cancer patients. 4. To find out the differences between the effect of artificial saliva and cold application based on patient demographics and clinical data.
NCT07293013
Backgroud: Radiation therapy and concurrent chemoradiotherapy are the main treatment methods for patients with head and neck cancer, which often lead to many severe oral mucositis (OM). It is easy to cause dry mouth and infection, which seriously affects the comfort and quality of life of patients. There are many pharmacological and non-pharmacological mouthwash solutions in clinical practice, the purpose of which is to reduce bacterial accumulation in order to prevent and improve OM. Olive oil has powerful moisturizing, antioxidant and anti-inflammatory properties. There is no research on the use of olive oil in the prevention or treatment of OM. Objective: The purpose of this study was to evaluate the preventive and therapeutic effects of olive oil as a mouthwash solution on OM caused by radiation therapy or concurrent chemoradiotherapy. Methods: The research design of this study is a randomized controlled trial. Patients from a radiation oncology clinic of a regional teaching hospital in southern China were invited to participate in the study by intentional sampling. The study will be followed for 12 weeks and will collect data before and after treatment with olive oil mouthwash or standard care. Assessment tools include demographic characteristics, severity of OM (RTOG and OMAS), degree of dry mouth (XQ and Saxon test), pain severity(VAS), Shortened General Comfort Questionnaire (SGCQ) and head and neck cancer patients quality of life scale (FACT-H\&N). The research data will be statistically analyzed by SPSS 22.0 statistical software, and the statistical significance is defined as the P value less than 0.05 as the significant level. Statistical methods include 1) Descriptive statistics include times, percentages, averages, standard deviations, etc. 2) Inferential statistics: Chi-square test, independent t-test, paired t-test and Logistic regression were used to compare the post-test data between the experimental group and the control group, and to detect the effectiveness of intervention measures and 3) Using generalized estimating equations (GEE) to predict the effect of interventions (repeated measures) on OM severity, dry mouth, body weight, quality of life and comfort scores. Expected outcomes: This study aimed to investigate the efficacy of gargling with olive oil in reducing the incidence of OM, severity of OM, severity of dry mouth, severity of pain, and improved patient comfort and quality of life.
NCT07252557
This single-center randomized controlled trial evaluates the effects of cold (15-20°C) versus room-temperature (30-35°C) water gargling on oral mucositis severity, pain, and comfort in patients with head and neck cancer undergoing radiotherapy. Participants will rinse their mouth four times daily for 30-60 seconds over a 6-week radiotherapy course, with follow-up for two additional weeks. The study hypothesizes that cold-water rinsing can reduce the severity of radiation-induced oral mucositis (RTOM) and pain, improve oral comfort, and minimize treatment interruptions.
NCT07186114
This study aimed to assess the efficacy of MEBO® in the treatment of already established oral mucositis. This is a randomized controlled clinical trial. The study included 36 patients with established oral mucositis, divided into two groups. Patients were randomly allocated to either receive topically applied MEBO® ointment or Benzydamine Hydrochloride (Tantum Verde) mouthwash three times a day for two weeks. We assessed the World Health Organization mucositis score (WHO), the Oral Mucositis Assessment Scale (OMAS), and the Patient-Reported Oral Mucositis Symptom (PROMS) score at baseline, and after one and two weeks.
NCT06968520
Radiotherapy is the main treatment method for head and neck tumors. However, almost all patients with head and neck tumors will develop acute inflammatory reactions such as Radiotherapy-Induced Oral Mucositis (RIOM) after receiving Radiotherapy, resulting in a decline in the quality of life of patients, hindering the smooth implementation of the treatment plan, reducing the therapeutic effect, and increasing the economic burden of patients. However, the current treatment strategies for RIOM focus on symptomatic treatment and have little impact on the course, severity and related complications of mucositis. Therefore, exploring effective strategies, predicting the incidence and severity of RIOM in patients, and providing prevention and treatment are the clinical bottlenecks and cutting-edge issues that urgently need to be solved in the current clinical practice of radiotherapy for head and neck tumors. Previous studies have shown that the steady-state of metallic elements may be closely related to the occurrence and development of RIOM. Therefore, we plan to conduct a prospective, single-center, observational study to further explore the correlation between metal elements and severe RIOM, analyze its predictive efficacy, and observe the dynamic changes of metal elements in radiotherapy.
NCT06862817
Oral mucositis, a painful inflammation and ulceration of the mucous membranes in the mouth, is commonly seen in patients undergoing chemotherapy or radiation therapy. Effective management of this condition is crucial to reduce pain, promote healing, and maintain oral function. Benzydamine mouth gel is a non-steroidal anti-inflammatory drug (NSAID) with analgesic and anti-inflammatory properties, making it useful in treating oral mucositis. It works by blocking pain and reducing inflammation, helping to relieve symptoms like soreness and swelling. Studies suggest that benzydamine gel can decrease the severity of mucositis, ease discomfort, and improve patients' quality of life. Aloe vera gel is well-known for its soothing, anti-inflammatory, and wound-healing properties. When applied to oral mucositis lesions, it promotes healing by providing hydration and forming a protective barrier over the affected tissue. Aloe vera's natural compounds, such as glycoproteins and polysaccharides, help in pain relief and accelerate tissue repair, making it a complementary option to reduce mucositis severity. Together, benzydamine and aloe vera gels can be effective in managing oral mucositis. Benzydamine offers immediate pain relief and reduces inflammation, while aloe vera aids in longer-term healing and tissue regeneration. This combination approach has shown promise in enhancing comfort and accelerating recovery for patients with mucositis.
NCT04110977
The goal of this randomized trial is to investigate whether the addition of a reminder app to standard care leads to a reduction of dermatitis and oral mucositis during radio(chemo)therapy for locally advanced squamous cell carcinoma of the head-and-neck (SCCHN). The primary endpoint is the rate of patients experiencing grade ≥2 radiation dermatitis at 60 Gy of radiotherapy. 80 patients are required per arm within the full analysis set. Taking into account that 5% of patients will not qualify for full analysis set, 168 patients should be randomized. If the addition of a reminder app to standard care will result in a significant reduction of radiation toxicity, it could become a helpful tool for these patients.