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Oral Mucositis clinical trials

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NCT ID: NCT05994638 Recruiting - Oral Mucositis Clinical Trials

Polyphenol Rich Aerosol as a Support for Cancer Patients in Minimizing Side Effects After a Radiation Therapy

Start date: August 21, 2023
Phase: N/A
Study type: Interventional

The aim of the study is to demonstrate in a clinical condition the effectiveness of a preparation that is a mixture of plant extracts rich in polyphenolic compounds in the aspect of supporting cancer patients in minimizing side effects after a radiation therapy cycle.

NCT ID: NCT05966194 Recruiting - Oral Mucositis Clinical Trials

RRx-001 for Reducing Oral Mucositis in Patients Receiving Chemotherapy and Radiation for Head and Neck Cancer

KEVLARx
Start date: April 2, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine if RRx-001, which is added on to the cisplatin and radiation treatment, reduces the incidence of severe oral mucositis in patients with head and neck cancers. All patients in this study will receive 7 weeks of standard of care radiation therapy given with the chemotherapy agent, cisplatin. Patients will receive RRx-001 or placebo before start of standard of care treatment.

NCT ID: NCT05913895 Active, not recruiting - Pain Clinical Trials

The Effect of Hydrogen Water in Oral Mucositis in Head and Neck Cancer Patients After Therapy

Start date: December 24, 2023
Phase: N/A
Study type: Interventional

Inpatients or outpatients diagnosed with head and neck cancer who met the inclusion and exclusion criteria were referred to the co-investigator(Dr. Chih-Jen Huang and Dr. Hui-Ching Wang), who then personally explained to each participant, the purpose and conduct of the study, so that they all understood their rights and interests before giving a written consent.

NCT ID: NCT05871333 Recruiting - Colorectal Cancer Clinical Trials

Effect of Losartan on the Incidence and Severity of Chemotherapy-Induced Mucositis in Gastrointestinal Cancer Patients

Start date: July 17, 2023
Phase: Phase 2
Study type: Interventional

Mucositis is a common and clinically significant side effect of both anticancer chemotherapy and radiation therapy that can affect any portion of the gastrointestinal tract. Not only associated with an adverse symptom profile, but also it may limit patients' ability to tolerate treatment if not adequately prevented and managed. Moreover, it may be associated with secondary local and systemic infection and poor health outcomes, and generates additional use of healthcare resources resulting in additional costs. Based on study of 38 patients of mean age sixty-one years old diagnosed with colorectal carcinoma were included to evaluate gastrointestinal adverse effect with different schedules of FOLFOX. Incidence of oral mucositis with FOLFOX-4 Is 76%, FOLFOX-6 is 62%, mFOLFOX-6 is 79% and FOLFOX-7 is 93% Chemotherapy-induced mucositis is commonly described as a five-phase sequence: initiation (0-2 days),upregulation and activation of messengers (2-3 days), signal amplification (2-5 days), ulceration with inflammation (5-14 days) and healing (14-21 days) According to the model introduced by some studies the primary inducer involved in unleashing mucosal injury upon chemotherapy is the production of reactive oxygen species (ROS), leading to tissue inflammation and mucositis induction. Inflammatory signaling pathways are upregulated during high reactive oxygen species states which further contribute to cytotoxicity. leading to the third step in the oral mucositis pathway. In this inflammatory phase, cytokines including Tissue Necrosis Factor alpha (TNF-α), prostaglandins, Nuclear factor Kappa β (NF-кβ), and interleukin (IL) 1β are released. The cytotoxic effects of chemotherapy, inflammation, and reactive oxygen species-mediated DNA damage result in gradual apoptosis of mucosal epithelial cells. Ulcerative sites become relatively neutropenic which predisposes them to bacterial and yeast infections. These bacterial toxins further simulate the underlying inflammatory state through release of additional cytokines. It is necessary to emphasize that oral mucositis is frequently documented only in its advanced phases owing to the requirements for clinical therapy and assistance. Therefore, the search for new active ingredients that could be used in the prevention (and even treatment) of oral and intestinal mucositis is of utmost importance.

NCT ID: NCT05853692 Recruiting - Oral Mucositis Clinical Trials

Prevention of Oral Mucositis in Head and Neck Cancer.

OMHNC-1
Start date: October 10, 2022
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05849571 Completed - Oral Mucositis Clinical Trials

Investigation of the Effect of Oral Care With Coconut Oil on the Degree of Oral Mucositis in Pediatric Oncology Patients

Start date: March 1, 2023
Phase: N/A
Study type: Interventional

Oral mucositis is characterized by ulcerative and inflammatory changes in the oral mucosa and is frequently seen in pediatric oncology patients receiving chemotherapy. Oral mucositis negatively affects the child's daily life functions, nutrition and quality of life. Pain is the most commonly reported side effect in mucositis. Pain impairs patients' ability to chew, swallow and speak, leading to inadequate fluid/nutrient intake, malnutrition and communication problems. Weight loss, dehydration, mucosal ulceration, fluid-electrolyte imbalance may develop in patients who cannot be fed adequately, and total parenteral nutrition (TPN) can be started. Other important complications of oral mucositis are oral bleeding and infection. The ulcerated oral mucosa creates an entrance gate for microorganisms, increasing the risk of bacterial/fungal/viral infections. Infections may be limited only to the oral mucosa, as well as systemic infection and septicemia. As a result, the length of hospital stay of the patients increases, the treatment costs increase and their quality of life deteriorates. Therefore, early diagnosis of oral mucositis, planning and implementation of oral care are important. Responsibility of nurses in the management of oral mucositis; monitoring the oral cavity for symptoms, diagnosing mucositis, providing appropriate oral care, and educating patients. In this context, it is extremely important to prevent oral mucositis, to evaluate the oral mucosa using a scale, and to reduce the degree of oral mucositis, that is, to perform appropriate oral care for its recovery, in terms of preventing other health problems and ensuring the well-being of the child. The aim of this thesis is to determine the effect of oral care with coconut oil on the degree of oral mucositis in pediatric oncology patients.

NCT ID: NCT05818007 Completed - Oral Mucositis Clinical Trials

Is Hyaluronic Acid Gel Effective on Oral Mucositis in Children Who Receiving Chemotherapy

Start date: April 1, 2022
Phase: Phase 4
Study type: Interventional

Oral mucositis (OM) is a common side effect of systemic chemotherapy (CT) in cancer patients. The aim of this study was to investigate the effect of hyaluronic acid (HA) gel on OM in children receiving CT.

NCT ID: NCT05811195 Recruiting - Oral Mucositis Clinical Trials

Comparison of Prophylactic Photobiomodulation Protocols in Chemoinduced Oral Mucositis in Oncology Patients

Start date: March 10, 2023
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05759975 Recruiting - Xerostomia Clinical Trials

Effectiveness of Extraoral Photobiomodulation in Management of Oral Adverse Effects in Patients Undergoing HSCT

Start date: January 13, 2023
Phase: N/A
Study type: Interventional

Patients undergoing hematopoietic cell transplantation (HSCT) receive high doses of chemotherapy with or without radiotherapy to eradicate the underlying disease, which induces a series of adverse effects, including in the oral cavity. Among the most common oral lesions is oral mucositis (OM), which has been associated with greater morbidity and important biological and economic impact.Currently, photobiomodulation (PBM) with intraoral application has been recommended for the prevention of OM, however, few studies have evaluated the impact of its extraoral use.

NCT ID: NCT05705622 Completed - Nurse's Role Clinical Trials

The Effect of Nursing Education on Oral Mucositis in Bone Marrow Transplant Patients

Start date: September 1, 2022
Phase: N/A
Study type: Interventional

In this study, it is aimed to examine the effect of oral care training for oral mucositis, which will be given by the researcher to patients who have undergone bone marrow transplantation, on the incidence and severity of oral mucositis in patients. The aim of the study is to be carried out in a public and private hospital in Antalya province, in two different hospitals with a public and private status, and with a total of 60 patients, 30 of which are in the experimental group and 30 in the control group. In the study, "oral care training for oral mucositis" and "oral mucositis follow-up procedure" will be developed by the researcher for bone marrow transplant patients. Bone marrow transplant patients will be educated and followed up according to the follow-up procedure before starting the chemotherapy regimen treatments planned before the transplant.