Clinical Research Directory

A Study of Phenytoin Mucoadhesive Film for Oral Ulcers in Healthy Volunteers

The goal of this clinical trial is to learn if a new 1% Phenytoin mucoadhesive film is safe and works to treat oral ulcers in healthy adult volunteers and patients with oral ulcers. The main questions it aims to answer are the following: Is the 1% Phenytoin film safe and well-tolerated when placed on oral ulcers? Does the film reduce pain and improve ulcer healing compared to a blank film? Researchers will compare participants receiving the 1% Phenytoin mucoadhesive film to those receiving a blank (placebo) film to see if the active film improves healing and reduces pain. Participants will: Have the assigned film placed directly over their oral ulcer once daily for 7 consecutive days. Attend regular clinic visits for check-ups, including blood tests and monitoring of ulcer appearance, body weight, and food intake. Report any pain, discomfort, or changes in their condition to the research team.

A Clinical Study to Compare BupiZenge With Lidocaine for Pain Due to Oral Mucositis in Patients With Head and Neck Cancer.

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.

Prevention of Oral Mucositis in Adults in With Hematologic Malignancy

The goal of this quasiexperimental cohort controlled intervention study is to learn if aloe vera mouthwash works better than usual care in the prevention and treatment of oral mucositis. Researchers will compare aloe vera to usual care. Participants in the intervention group will rinse their mouths with aloe vera 4 x/day for 28 days of their treatment. They will also complete questionnaires about oral health and mucositis.

Copaíba-based Mouthwash in Oral Mucotitis Prevention and Treatment in Oral Cancer Patients During Radioteraphy

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.

Effect of Sodium Bicarbonate, Saline and Black Mulberry Syrup on Degree of Oral Mucositis in Children Receiving Chemotherapy

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.

Study of a New Medical Device for Oral Mucositis

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.

Lactobacillus Rhamnosus GG Alleviates Oral Mucositis in Patients Undergoing Radiotherapy

Radiation therapy is a common treatment modality in the management of head and neck malignancies. However, head and neck tumors often have some adverse reactions when receiving radiation therapy, such as dry mouth, change of taste, oral mucositis, etc. Among them, the incidence of oral mucositis is more than 90%, and the incidence of oral mucositis of degree 3 or more than degree 3 is more than 50%. Severe oral mucositis seriously affects the quality of survival of patients. Lactobacillus rhamnosus GG (LGG) is a type of lactic acid bacterium, which is an important component of the microbiota in many parts of the human body. Lactobacillus rhamnosus GG (LGG) is a lactic acid bacterium found in the human body, extensively researched for its probiotic properties. It has been tested in clinical trials for preventing and treating oral mucosal reactions during intensified radiotherapy for head and neck squamous cell carcinoma. LGG adheres well to epithelial layers, produces a protective biofilm, and modulates immune responses. It shows promise in reducing radiation-induced oral mucositis and can be safely used in infant formula. Additionally, a daily dosage of 3×10\^9 CFU of LGG has been effective in treating irritable bowel syndrome without adverse effects

Study of a Copaiba-Based Mouthwash Combined With Low-Level Laser Therapy in the Prevention of Oral Mucositis in Patients Undergoing Hematopoietic Stem Cell Transplantation

Oral mucositis (OM) one of the most significant acute toxicity of Hematopoietic Stem Cell Transplantation (HSCT). There is already scientific evidence suporting OM the use of: low-level laser therapy (LLLT), cryotherapy (in autologous HSCT when conditioning regimens include high-dose melphalan), and keratinocyte growth factor (in autologous HSCT with high-dose chemotherapy associated with RT). 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 HSCT was proposed. Patients will be randomized into 2 groups: A (copaíba) and B (placebo) and will use the mouthwash 4x/day. Each group will have 38 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 neutropenic recovery.

Effect of a Standardized Oral Care Program on Oral Mucositis in Children Undergoing Hematopoietic Stem Cell Transplantation: A Randomized Controlled Trial(SOC-HSCT)

Oral mucositis is one of the most common and debilitating complications in pediatric patients undergoing hematopoietic stem cell transplantation (HSCT). Severe oral mucositis can lead to pain, nutritional impairment, infection, prolonged hospitalization, and increased healthcare costs. This randomized controlled trial aims to evaluate whether a standardized oral care program consisting of caregiver education, supervised tooth brushing, sodium bicarbonate mouth rinsing, oral moisturizing, and compliance monitoring can reduce the incidence and severity of oral mucositis compared with routine oral care. A total of 126 pediatric HSCT recipients will be randomly assigned in a 1:1 ratio to the intervention or control group. Clinical outcomes, oral pain, inflammatory biomarkers, oral microbiota, and metabolomic profiles will be evaluated throughout the transplantation period.

Retrospective Observational Study of Oral Complications and Quality of Life in Head and Neck Cancer Patients Treated With Radiotherapy or Chemoradiotherapy.

Head and Neck cancer patients receiving radiation therapy (with or without chemotherapy) suffer several oral complications, such as oral mucositis, which impairs quality of life of patients during radiotherapy and in the post-treatment follow-up period. The use of topical agents to protect oral mucosa against radiation-induced toxicity is part of the routine clinical practice. Among these products, the use of mouthwashes and/or gels are extensively used in the Centro Oncológico Clara Campal - Hospital HM Sanchinarro. Once such product is a proprietary formulation based on natural ingredients such as olive oil, betaine, and xylitol (Mucosa Innovations S.L.).

Chlorophyllin for Reducing Oral Mucositis in Total Body Irradiation Prior to Transplant

The goal of this phase II, single-arm interventional clinical trial is to evaluate whether oral sodium copper chlorophyllin (CHL) can reduce the frequency and severity of oral mucositis in patients aged 12-65 years undergoing myeloablative total body irradiation (TBI) as part of conditioning before their first allogeneic Hematopoietic Stem Cell Transplantation (HSCT). The main questions it aims to answer are: Does oral chlorophyllin reduce the incidence of Grade III and IV oral mucositis by day +28 after HSCT? Does oral chlorophyllin reduce the duration of severe oral mucositis and the need for total parenteral nutrition (TPN), opioid analgesics, and other treatment-related toxicities, while maintaining acceptable safety? Participants will: Receive oral sodium copper chlorophyllin 750 mg once daily (tablet or oral suspension) starting 48 hours before TBI conditioning and continuing until day +28 after HSCT. Undergo standard myeloablative TBI-based conditioning and allogeneic Hematopoietic Stem Cell Transplantation (HSCT) as part of routine clinical care. Have regular clinical assessments for oral mucositis, treatment-related toxicities, engraftment, and graft-versus-host disease (GVHD). Provide blood and saliva samples at predefined time points for cytokine and pharmacokinetic analyses.

Laser Therapy Versus Ozone Therapy for Oral Mucositis in Patients With Cancer

This retrospective observational study will compare laser therapy and ozone therapy for the management of oral mucositis in adults with head and neck cancer. Oral mucositis is a painful inflammation of the mouth that may develop during radiotherapy, chemotherapy, or concurrent chemoradiotherapy and can cause redness, ulceration, difficulty eating or swallowing, and reduced quality of life. The study will review existing clinical records of patients who previously received either laser therapy or ozone therapy as part of routine clinical care. Patients were not assigned to treatment by the study protocol, and no additional treatment or study procedures will be performed. The main outcome will be the change in oral mucositis severity measured using the World Health Organization oral mucositis scale. Secondary outcomes will include changes in oral pain measured using a visual analogue scale and changes in oral mucositis-related quality of life, when questionnaire data are available. The aim is to determine whether the clinical course of oral mucositis differs between patients treated with laser therapy and those treated with ozone therapy.

Coconut Oil to Prevent Mouth Sores in Pediatric Patients Receiving High Dose Chemotherapy

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.

Laser Mucite ORL : Effectiveness of Laser Therapy for Mucositis Induced by a Radio-chemotherapy in Head and Neck Cancer

The purpose of the study is to assess in a randomized, double blind, controlled, multi-center, phase III study, the efficacy of low level diode laser (100 MW, 658 Nm), in the prevention and treatment of radiochemotherapy-induced mucositis for stage III and IV head and neck carcinomas.

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

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.

Ozone Therapy for Cancer Therapy-Related Oral Mucositis

This retrospective observational study will evaluate clinical data already available from adult cancer patients who developed cancer therapy-related oral mucositis during radiotherapy and/or chemotherapy and who were managed in routine clinical practice with combined chairside and domiciliary ozone therapy. The study will not assign participants to any treatment and will not involve any new intervention, visit, examination, or change in patient care. Data will be extracted from existing medical records and clinical documentation. The main purpose of the study is to describe the clinical course of oral mucositis and to evaluate the time needed to reach oral mucositis grade 1 or lower according to the World Health Organization Oral Toxicity Scale. The study will also assess changes in oral pain intensity, measured using a 0 to 10 Visual Analogue Scale, from baseline to follow-up visits up to 15 days. Exploratory analyses will compare clinical trends between patients with head and neck cancers and patients with cancers in other anatomical sites. The results will be interpreted as descriptive and exploratory because the study is retrospective, single-arm, and has no control group.

Traditional Chinese Medicine for the Prevention of Radiotherapy-Induced Oral Mucositis (RTOM)

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.

Effect of a Novel Topical Composition on the Incidence of Severe Oral Mucositis in Head & Neck Cancer Radiated Patients and Quality of Life Assessed by PROMs.

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.

Amimestrocel Injection for Preventing Severe Oral Mucositis in HSCT Patients

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.

Ozone Therapy With Biomimetic Oral Care for Cancer-Related Oral Mucositis

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.

Prevention of Oral Mucositis in Head and Neck Cancer.

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.

Efficacy of High-Level Laser Therapy in Managing Oral Mucositis Among Pediatric Patients Undergoing Hematopoietic Stem Cell Transplantation

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 .

A Study to Describe the Effect of Photobiomodulation (Low Level Laser Therapy) in Reducing the Severity and Incidence of Oral Mucositis (Oral Ulceration) in Oral Cancer Patients Undergoing Radiation Treatment

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.

Photobiomodulation in the Prevention and Management of Oral Mucositis in Children

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.