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Oral Mucositis clinical trials

View clinical trials related to Oral Mucositis.

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NCT ID: NCT05175222 Completed - Oral Mucositis Clinical Trials

Assessment of Efficacy of LightWalker (Nd:Yag, Er:Yag) Laser Therapy on Incidence, Severity and Duration of Oral Mucositis in Patients Undergoing Hematopoietic Stem Cell Transplantation (HSCT). Prospective Randomized Open-label Study

Start date: January 1, 2019
Phase: N/A
Study type: Interventional

Oral mucositis (OM) is a common and debilitating adverse effect of conditioning regimens in patients undergoing hematopoietic cell transplantation (HCT). It is treated symptomatically with pain relief medications. The use of low-level laser therapy (LLLT) to prevent tissue damage has been postulated for almost forty years, however, there are only a few reports concerning old generation lasers in mucositis prophylaxis in HCT recipients. Here we hypothesized, that a new generation LLLT (Nd: YAG Fotona LightWalker®) laser may be an effective prophylaxis in shortening and reducing the severity of this complication.

NCT ID: NCT05161091 Recruiting - Oral Mucositis Clinical Trials

Efficacy of Orosol® in the Treatment of Chemo- and Radiation-induced Mucositis.

OROSOL
Start date: November 22, 2022
Phase: N/A
Study type: Interventional

Oral mucositis is one of the most debilitating side effects of radiation therapy and various forms of chemotherapy, especially for head and neck cancers and hematopoietic stem cell transplants. It is a consequence of the cytostatic effects of anticancer treatments on rapidly renewing cells of the oral mucosa; An ulcer appears which will increase in size due to subsequent bacterial, fungal and / or viral growth, while the leakage of toxins through damaged capillaries causes irritation and a burning sensation. Proteolytic enzymes, known to destroy the extracellular matrix, inhibit cell regeneration and healing. Depending on the severity of the ulceration, infection and feeding possibilities, mucositis is scored between grade 0 (absent) and grade 4 (maximum) (according to the WHO (World Health Organization) classification or the NCI-CTCAE (National Cancer Institute-Common Terminology Criteria for Adverse Events), the latter degree most often requiring a modification of the anticancer treatment which may have an impact on the prognosis of the disease. Although, theoretically, mucositis is easy to treat because it only requires simple cleaning of the ulcers and stimulation of the growth of the underlying healthy cells to make up for the loss of substance, there are currently only limited symptomatic treatments available.

NCT ID: NCT05104268 Withdrawn - Oral Mucositis Clinical Trials

Study of a New Medical Device for Oral Mucositis

MDOM
Start date: November 30, 2024
Phase: Early Phase 1
Study type: Interventional

This is a single-center randomized controlled trial of a new medical device (Bocaliner™) that has been designed to improve the treatment of chemotherapy-induced oral mucositis in patients undergoing cancer treatment. The goal of this study is to determine tolerance and response to the use of Bocaliner™ as reported by patients with chemotherapy and/or radiation therapy-induced oral mucositis.

NCT ID: NCT05101889 Completed - Oral Mucositis Clinical Trials

Benefits of Immunonutrition in Patients With Head and Neck Cancer Receiving Chemoradiation

Start date: January 11, 2013
Phase: Phase 2
Study type: Interventional

This study evaluated the benefits of immunonutrition regarding the prevention of severe mucositis. Patients with head and neck cancer (HNC) undergoing definitive concurrent chemoradiation including 3-week cycles of cisplatin were enrolled in this double-blind phase II study. Patients were randomly assigned to receive an immunonutrition containing omega-3-fatty acids, arginine, dietary nucleotides, and soluble fiber or an isocaloric isonitrogenous control. All patients received the assigned product 5 days before each chemotherapy session. The proportion of patients with severe mucositis was compared between the immunonutrition and control groups.

NCT ID: NCT05059613 Not yet recruiting - Quality of Life Clinical Trials

Thalidomide With or Without Probiotics in Radioactive Oral Mucositis

Start date: September 20, 2021
Phase: N/A
Study type: Interventional

Study on the application of thalidomide with or without probiotics in radioactive oral mucositis

NCT ID: NCT05040425 Not yet recruiting - Clinical trials for Head and Neck Cancer

Radioprotective Effect of Chinese Herbal Medicine on Oral Mucositis

Start date: August 30, 2021
Phase: Phase 2
Study type: Interventional

This protocol describes a randomized, double-arm, parallel-group, open-label controlled study that aims to evaluate the efficacy of Chinese herbal medicine on head and neck cancer patients with oral mucositis toxicities and quality of life during radiotherapy.

NCT ID: NCT04995354 Not yet recruiting - Oral Mucositis Clinical Trials

Efficacy of EGF-loaded Self Healing Gel in Treatment of Oral Mucositis

Start date: June 1, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

Cancer treatment, including radiation along with aggressive chemotherapy, increases the patient's survival rate. However, they possess toxic side effects. Oral mucositis is one of the most serious complications of cancer treatment, which occurs in most of patients receiving cancer therapy. Mucositis can dramatically affect the patient's quality of life .Epidermal growth factor (EGF) is a dominant factor in early keratinocyte differentiation, proliferation and migration. However, a major obstacle in most studies is that there isn't prolonged contact between the applied treatment and the oral mucosa to achieve the optimum therapeutic effect. Thus, a new vehicle for EGF is needed to achieve sufficient prolonged contact with oral mucosa. The present project aims at employing EGF as therapeutic agent for mucositis dealing with the challenges of delivery of such macromolecule to the oral mucosa by using self-healing gels to maximize the drug effect.

NCT ID: NCT04915599 Completed - Oral Mucositis Clinical Trials

Feasibility and Patient Reported Tolerance of Cryotherapy With the Cooral ® Mouth Cooling Device [MCD) in Patients Undergoing Radiation Therapy

CooRay
Start date: June 22, 2021
Phase: N/A
Study type: Interventional

This study is to investigate the use of the Cooral ® standardized CyT device to achieve a constant and reproducible cooling of the oral mucosa to prevent OM in patients undergoing RT in the head and neck region.

NCT ID: NCT04911335 Completed - Oral Mucositis Clinical Trials

Propolis-based Product (FARINGEL PLUS) for Oral Mucositis in Palliative Care

FARINGEL-CP
Start date: July 13, 2021
Phase: Phase 2
Study type: Interventional

Oral health is crucial for palliative patients' quality of life. The evidence on effective interventions and measures of oral mucositis in palliative care is sparse. This is a single-center, prospective, uncontrolled open label Phase 2 non-profit study, aimed at evaluating a propolis-based product (FARINGEL PLUS) added to basic oral hygiene safety, acceptability and activity in preventing and treating oral mucositis in patients in palliative care. A two-step design was adopted according to Simon's Optimum approach, with an overall sample of 77 evaluable cases (step1_26 cases; step2_51 cases).

NCT ID: NCT04880148 Recruiting - Xerostomia Clinical Trials

The Effectiveness of a Thyme and Honey Spray for Oral Toxicities

HONEY
Start date: November 3, 2021
Phase: N/A
Study type: Interventional

Aim: To evaluate the effectiveness of thymus honey on radiation induced-oral mucositis and xerostomia. Background: Oral mucositis and xerostomia are two of the most severe side effects that head and neck cancer patients confront during and after the completion of radiotherapy. Although several medications are used for their treatment, these fail to provide a fully effective and comprehensive management. Honey and thyme have been studied for the management of various treatment-related side effects. Design: Α double blinded randomised controlled trial will be used for this study. Methods: 200 head and neck cancer patients who receive radiotherapy will be included in this study. Patients will be randomised and divided into two equal groups of 100 participants; the intervention group (oral spray with thyme and honey + standard care) and the control group ( placebo spray + standard care). Assessments with xerostomia and oral mucositis scales additionally to 4 self-administered questionnaires will occur in both groups at baseline and then weekly and 6 months following completion of treatment. The duration of the study will be 3 years from the day of approval of this research protocol.