Oral Mucositis

Most patients who receive radiation therapy for head and neck cancer develop painful sores in the mouth called oral mucositis. For many of them, these sores are severe and result in debilitating pain. The sores usually start in the third week of radiation and last aboutfive weeks, often continuing for two weeks after treatment ends. Current pain treatments, for instance lidocaine solution, only give short-lasting pain relief. BupiZenge is a lozenge that dissolves slowly in the mouth and contains bupivacaine. Bupivacaine is a long-acting pain-relieving medicine and has been safely used for many years for both children and adults, and its safety profile is well understood. The BupiZenge lozenge is designed to give longer and more reliable pain relief for patients with mucositis in their mouth. This study will check if BupiZenge works better to reduce pain than lidocaine, and if better pain control improves quality of life and reduces the need for strong pain medicines like opioids. The main goal is to see how much mouth pain decreases after taking BupiZenge compared to lidocaine. This is measured by asking the patients to rate their pain score on a scale from 0 (no pain) to 10 (worst possible pain). This is done at different time-points, from before the dose until three hours after dose on the last day of radiotherapy. The study will include 150 adults, both women and men, aged 18 to 80 years, who have head and neck cancer and are scheduled to receive radiotherapy, with or without chemotherapy. These patients will be randomly assigned to one of the treatment groups. The first is BupiZenge, which is a lozenge containing bupivacaine, which dissolves slowly in the mouth. The second is lidocaine, which is a liquid solution for use in the mouth that you gurgle or swish around in the mouth. The study begins with a combined screening and run-in period that can last up to five weeks. During radiotherapy, patients record their mouth pain each day using a number scale from 0 (no pain) to 10 (worst possible pain). If the pain score is at least 4 (moderate pain) and they have developed mucositis in the mouth within 5 weeks, patients are randomly assigned to receive either BupiZenge or Lidocaine. Treatment continues at least until radiotherapy is completed. If the patient has pain and mouth sores, and the treatment is working well, it may continue after radiotherapy ends, but only until the sores heal or for a maximum of six weeks in total, whichever occurs first. After treatment ends, there is a 30-day follow-up period.

Most patients who receive radiation therapy for head and neck cancer develop painful sores in the mouth called oral mucositis. For many of them, these sores are severe and result in debilitating pain. The sores usually start in the third week of radiation and last aboutfive weeks, often continuing for two weeks after treatment ends. Current pain treatments, for instance lidocaine solution, only give short-lasting pain relief. BupiZenge is a lozenge that dissolves slowly in the mouth and contains bupivacaine. Bupivacaine is a long-acting pain-relieving medicine and has been safely used for many years for both children and adults, and its safety profile is well understood. The BupiZenge lozenge is designed to give longer and more reliable pain relief for patients with mucositis in their mouth. This study will check if BupiZenge works better to reduce pain than lidocaine, and if better pain control improves quality of life and reduces the need for strong pain medicines like opioids. The main goal is to see how much mouth pain decreases after taking BupiZenge compared to lidocaine. This is measured by asking the patients to rate their pain score on a scale from 0 (no pain) to 10 (worst possible pain). This is done at different time-points, from before the dose until three hours after dose on the last day of radiotherapy. The study will include 150 adults, both women and men, aged 18 to 80 years, who have head and neck cancer and are scheduled to receive radiotherapy, with or without chemotherapy. These patients will be randomly assigned to one of the treatment groups. The first is BupiZenge, which is a lozenge containing bupivacaine, which dissolves slowly in the mouth. The second is lidocaine, which is a liquid solution for use in the mouth that you gurgle or swish around in the mouth. The study begins with a combined screening and run-in period that can last up to five weeks. During radiotherapy, patients record their mouth pain each day using a number scale from 0 (no pain) to 10 (worst possible pain). If the pain score is at least 4 (moderate pain) and they have developed mucositis in the mouth within 5 weeks, patients are randomly assigned to receive either BupiZenge or Lidocaine. Treatment continues at least until radiotherapy is completed. If the patient has pain and mouth sores, and the treatment is working well, it may continue after radiotherapy ends, but only until the sores heal or for a maximum of six weeks in total, whichever occurs first. After treatment ends, there is a 30-day follow-up period.

This is a multicenter, randomized, controlled, prospective clinical trial designed to observe and evaluate the safety and efficacy of Modified Dahuang Huanglian Xiexin Mouthwash for the prevention of radiotherapy-induced oral mucositis (RTOM). Participants will be randomly assigned to receive either the Modified Dahuang Huanglian Xiexin Mouthwash or Placebo Mouthwash. The study aims to assess the preventative effect on RTOM in patients undergoing radiotherapy.

This study aims to see if a single intravenous infusion of a cell therapy called Amimestrocel injection can help prevent severe mouth sores (oral mucositis) in patients receiving a stem cell transplant. Patients getting a stem cell transplant often receive strong chemotherapy (with radiation and/or a drug called melphalan) that can cause painful mouth and gut sores, making eating difficult and increasing infection risk. Amimestrocel injection is made from human umbilical cord cells that may help reduce inflammation and promote healing. About 22 adult patients scheduled for this type of transplant at one hospital in China will receive the infusion 1-2 days before their stem cell transplant. Researchers will closely check for mouth sores, pain, and side effects for the first 28 days, and continue safety monitoring for 100 days. The main goal is to see if the treatment lowers the rate of severe (Grade 3-4) mouth sores. The study will also track pain levels, need for pain medication, diarrhea, time for blood counts to recover, and overall safety.

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.

Oral mucositis is a frequent and often debilitating complication of radiotherapy and chemotherapy, particularly in patients treated for head and neck cancers. It is characterized by inflammation and ulceration of the oral mucosa, leading to pain, difficulty swallowing, taste disturbances, dry mouth, and impairment of daily activities. In more severe cases, oral mucositis may require modification or temporary interruption of cancer treatment. This randomized controlled clinical trial is designed to assess the clinical effectiveness of gas ozone therapy in patients with radio- and chemotherapy-induced oral mucositis. In addition, the study will evaluate whether combining ozone therapy with a structured biomimetic oral care regimen, including toothpaste and mouthwash, provides additional clinical benefit compared with ozone therapy alone. Eligible participants will be randomly assigned to one of two parallel groups. The control group will receive gas ozone therapy administered in an outpatient setting according to a standardized protocol. The experimental group will receive the same ozone therapy combined with a defined home oral care regimen. Each participant will be followed for 30 days. The primary outcome is the change in oral mucositis severity, assessed using the World Health Organization Oral Toxicity Scale. Secondary outcomes include oral pain intensity, salivary flow rates, perceived dry mouth, taste alterations, swallowing function, oral pH, overall oral health-related quality of life, and treatment tolerability. The findings of this study are expected to clarify the role of ozone-based supportive care strategies in the management of cancer therapy-related oral mucositis and to contribute to the development of standardized non-pharmacological treatment protocols.

The goal of this clinical trial is to learn if high-level laser therapy can manage oral mucositis in pediatric patients undergoing hematopoietic bone marrow transplantation. The main question it aims to answer is : Is high-level laser therapy effective as a treatment for oral mucositis in pediatric hemopoietic stem cell transplant patients? Researchers will compare patients receiving basic oral care to see the effect on the WHO oral mucositis scale. Participants will be subjected to high level laser on lesion sites .

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.

The goal of this study is to describe the effect of photobiomodulation (PBM) on the incidence and severity of oral mucositis in post-operative oral cancer patients receiving radiotherapy +/- chemotherapy. Participants will receive PBM treatment five times a week throughout the course of their radiotherapy. The main question it aims to answer is whether photobiomodulation reduces the incidence and severity of oral mucositis.

The investigators will conduct a 2-arm 6-month randomized clinical controlled trial to evaluate the effectiveness of an oral Telehealth Intervention (THI) in preventing cancer-related oral complications, improving oral health maintenance and oral health related quality of life, and reducing systemic inflammation compared to Usual Care (UC) among unselected cancer survivors.

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.

The purpose of this study is to learn if virgin coconut oil (VCO) mouth rinse can help prevent oral mucositis. The Study Investigator will compare standard of care mucositis prevention rinses with the VCO mouth rinse added to the standard of care mucositis prevention rinses. The severity of oral mucositis between the 2 groups will be evaluated. Some of the standard of care rinses that can be used to prevent mucositis are normal saline, Benadryl (diphenhydramine), Mylanta, lidocaine, or other combinations.

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.

This is a single center pilot study evaluating intraoral photobiomodulation for the prevention of oral mucositis in patients undergoing myeloablative allogeneic hematopoietic cell transplantation (alloHCT). Patients who are planned for alloHCT will receive daily intraoral photobiomodulation therapy (PBMT) using a novel LED device. The name of the study device involved in this study is: \- THOR LX2.3 with LED Lollipop

This study is a Phase 2, double-blind, randomized controlled trial evaluating the safety and efficacy of TV5M01 (a 5% green tea and 0.1% morphine gel) compared to triple mixture (0.19% lidocaine, 0.29% nystatin, and 5.50% hydroxides) for treating radiation-induced oral mucositis in patients with head and neck squamous cell carcinoma. The trial will enroll 40 patients (20 per group) with stage III-IV head and neck cancer receiving radiotherapy who develop grade 1 or higher mucositis. Participants will apply the assigned mouthwash three times daily from mucositis diagnosis until resolution. Primary outcomes include safety (incidence of infections and adverse events) and efficacy (duration of grade 3-4 mucositis, days with severe pain). Secondary outcomes include quality of life and analgesic use. Randomization will use minimization methodology to balance important prognostic factors. The study design incorporates two interim analyses after 10 and 19 participants, with clear safety monitoring and stopping rules. If successful, this trial could provide an evidence-based treatment option for radiotherapy-induced mucositis, potentially improving treatment completion rates and quality of life for head and neck cancer patients.

This study was planned as a randomized controlled experimental study in order to compare the effects of oral care with saline and black mulberry syrup in addition to sodium bicarbonate on oral mucositis level in children aged 6-18 years receiving chemotherapy.

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.

The aim of this feasibility trial is to determine if it is safe and feasible to treat oral health diseases in people with haematological cancers before they start their chemotherapy to reduce complications and disruption to planned chemotherapy dose or schedule.