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Mucositis clinical trials

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NCT ID: NCT05331131 Withdrawn - Clinical trials for Cancer of Head and Neck

Efficacy of Ketamine Mouthwash in the Management of Oral and Pharyngeal Toxicity Associated With Head and Neck Chemoradiotherapy: A Phase 2, Simon 2-stage Trial

Start date: September 19, 2022
Phase: Phase 2
Study type: Interventional

Patients with head and neck cancer generally receive a standard of care of 7 weeks of daily radiation therapy given alongside an aggressive chemotherapy drug called cisplatin. While rates of cure are often strong for patients who are able to complete treatment without any unscheduled breaks, the rates of high grade toxicity associated with this treatment are high even with the use of the most modern techniques of treatment. Pain, swallowing dysfunction, loss of taste sensation, and ulceration of the mouth and throat are ubiquitous and often contribute to a nutritional breakdown requiring feeding tube placement. Unfortunately, even with aggressive use of opioids and other conventional palliation methods, breakthrough pain and other toxicities are very common. In addition to the quality of life burdens of these side effects, patients who are unable to complete treatment on schedule have worse control of their cancer and worse overall survival. Clearly, there is a clinical need for better management of these toxicities. The investigators hypothesize that ketamine mouthwash may effectively reduce both pain and the need for opioid drugs in this patient population. There is a large body of literature supporting the use of ketamine for pain control in diseases other than cancer, and a smaller but growing body of literature showing the effectiveness of ketamine for control of cancer-associated pain. Additionally, by providing ketamine in mouthwash form, the evidence shows that one can avoid the side effects associated with giving ketamine throughout the body, and in fact no significant side effects have been reported so far with this treatment. In this study, the investigators will provide ketamine mouthwash to patients undergoing the standard treatment for this disease over a two week period, and measure their response in terms of both pain and need for opioids, as well as other measurements of quality of life. The investigators will also measure unscheduled interruptions in treatment. In years to come, the data from this study may show an impact on cancer control and survival.

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 (Bocalinerâ„¢) 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 Bocalinerâ„¢ as reported by patients with chemotherapy and/or radiation therapy-induced oral mucositis.

NCT ID: NCT03955224 Withdrawn - Clinical trials for Upper Aerodigestive Tract Neoplasms

Evaluation of Low-Level Laser Therapy Efficacy in Pain Management of Grade 2 Oral Mucositis Induced by Radiotherapy or Chemoradiotherapy: a Study in Patients With Upper Aerodigestive Tract Cancer

ESMULLLAT
Start date: March 2021
Phase: Phase 2
Study type: Interventional

Prospective, monocentric, randomized phase II study evaluating Low-Level Laser Therapy (LLLT) as a treatment for the pain due to grade 2 oral mucositis in patients with upper aero-digestive tract cancer treated by radiotherapy or chemoradiotherapy. Patients with upper aero-digestive tract cancer receiving their first cervicofacial radiotherapy or chemoradiotherapy will be included in this study if they suffer from oral mucositis due to their treatment. The study procedure will consist in 5 applications of the LLLT that will be performed at three days intervals for a maximum duration of 15 days. Each patient will be followed until 3 days after the end of the study treatment, for a total duration of the study of 18 days.

NCT ID: NCT03575858 Withdrawn - Clinical trials for Dental Implants, Single-Tooth

The Effect of Different Shapes of Interdental Brushes in the Management of Peri-implant Mucositis and Gingivitis

Start date: December 15, 2018
Phase: N/A
Study type: Interventional

Rehabilitation of edentulous spaces with dental implants has become a routine treatment option as implants enjoy high survival rates over time. Accompanying this increase in implant use, epidemiological studies have also reported escalating incidences of peri-implant diseases. A recent meta-analysis reported that peri-implant mucositis and peri-implantitis had high estimated weighted mean prevalences of 43% and 22% respectively. It is common knowledge that gingivitis is the precursor of periodontitis. Similarly, peri-implant mucositis too precedes peri-implantitis, which is a very challenging condition to treat. Therefore, it is strongly recommended that peri-implant mucositis is managed effectively and in a timely manner. In order to reduce the inflammatory burden within the periodontium, mechanical plaque removal is of utmost importance. Mechanical debridement alone, without any adjunctive aids e.g. chlorhexidine, was found to be effective in preventing per-implant mucositis in short-term clinical trials but did not always result in complete resolution of inflammation (Heitz-Mayfield, et al. 2011, Schwarz, et al. 2015). Therefore, it can be speculated that patient administered home care may play a role in eliminating soft tissue inflammation over time. The study aims to investigate and compare the efficacy of the barrel shaped and tapered interdental brushes in reduction of soft tissue inflammation through removal of interproximal plaque at both tooth and implant sites in patients with moderately rough surface tissue level or bone level dental implants, which were restored with single screw or cement retained crowns and in function for the past 2- 5 years. The hypothesis of the study is that The barrel shaped interdental brush can remove more supra- and sub-gingival plaque and thus have more reduction in soft tissue inflammation, compared to the tapered interdental brush.

NCT ID: NCT03348111 Withdrawn - Peri-Implantitis Clinical Trials

Establishing a New Protocol for Early Mucositis and Peri-implantitis Treatment Using an Air-polishing Device

PERIFLOW
Start date: June 2019
Phase: N/A
Study type: Interventional

Considering the frequent occurence of peri-implantitis and mucositis, a multiple of treatment alternatives have been proposed including non-surgical and surgical procedures. However, it seems that the most effective treatment remains prevention of these diseases. The aim of this study is to emphasize on mucositis and peri-implantitis prevention using an air abrasion device the Air-Flow Master Piezon® with erythritol and chlorhexidine powder in order to eliminate and / or disorganize the biofilm responsible for peri-implant mucosa inflammation.

NCT ID: NCT02589860 Withdrawn - Multiple Myeloma Clinical Trials

Analysis of Oral Mucositis in Patient's Undergoing Melphalan Conditioning and Autologous Stem Cell Transplant

Start date: October 30, 2015
Phase:
Study type: Observational

This is a pilot study to explore and identify changes in molecular processes within the oral mucosa that are associated with the development of oral mucositis (OM) in patients treated with Melphalan who undergo autologous peripheral blood stem cell transplantation.

NCT ID: NCT01820091 Withdrawn - Clinical trials for Non-Small Cell Lung Cancer

Phase 1 Study of Fusilev® to Prevent or Reduce Mucositis in Patients With Non-Small Cell Lung Cancer Receiving Folotyn®

Start date: April 2013
Phase: Phase 1
Study type: Interventional

To determine the optimal dose and schedule of Fusilev to prevent or reduce Folotyn-related Grade 3 or higher oral mucositis in patients with Non-Small Cell Lung Cancer.

NCT ID: NCT01797952 Withdrawn - Clinical trials for Oral Mucositis in Patients Undergoing HSCT

A Phase III Study of Efficacy of Lactobacillus CD2 Lozenges in Preventing High-Dose Chemotherapy Induced Oral Mucositis in Patients Undergoing Myeloablative Hematopoietic Stem Cell Transplantation

mucositis
Start date: November 2015
Phase: Phase 3
Study type: Interventional

The study will be conducted at departments of Medical Oncology and Hematology, All India Institute of Medical Sciences (AIIMS). Patients with various malignancies who are taken up for high dose chemotherapy followed by stem cells transplant (blood and marrow transplant) have very high chances of developing severe oral mucositis (generally 60-80% in different studies and our own previous experiences). This not only causes significant morbidity but also hampers quality of life needing use of parenteral nutrition, analgesics, and antibiotics. No definite treatment exists for prevention or treatment of oral mucositis in this group of patients. Though one study has suggested that use of IV palifermin (a keratinocyte growth factor) will reduce duration and severity. Palifermin is very expensive and not available in country. Recently investigators have shown effectiveness of a probiotic Lactobacillus CD 2 in reducing incidence and severity of chemo-radiotherapy induced mucositis in head and neck squamous cell cancer patients. (Published online in European Journal of Cancer: http://dx.doi.org/10.1016/j.ejca.2011.06.010)European Journal of Cancer 2012;4:875-881.No significant toxicity has been reported with its use. A pilot study on similar aspect was completed recently at our center(Clinical trial.gov identifier:NCT 01480011) and in 31 patients who received this only 6 (20%) developed grade III or IV Mucositis. Now, investigators want to study the efficacy of this drug to reduce severity of mucositis in patients undergoing myeloablative hematopoietic stem cell transplantation. The study drug and placebo will be supplied by CD Pharma India Private Limited. Investigators further give undertaking that study will be carried as per GCP and declaration of Helsinki.

NCT ID: NCT01789723 Withdrawn - Clinical trials for Non Hodgkin's Lymphoma

Phase 1 Study of Fusilev to Prevent or Reduce Mucositis in Patients With Non-Hodgkin's Lymphoma Receiving Folotyn

Start date: March 2013
Phase: Phase 1
Study type: Interventional

The purpose of this study is determine the optimal dose and schedule of Fusilev to prevent or reduce Mucositis in patients with Non-Hodgkin's Lymphoma receiving Folotyn treatment.

NCT ID: NCT01728480 Withdrawn - Mucositis Clinical Trials

Entolimod in Treating Patients With Stage III-IV Squamous Cell Head and Neck Cancer Receiving Cisplatin and Radiation Therapy

Start date: January 2014
Phase: Phase 1
Study type: Interventional

This phase I trial studies the side effects and best dose of entolimod in treating patients with stage III-IV or recurrent head and neck cancer. Biological therapies, such as entolimod, may stimulate the immune system in different ways and stop tumor cells from growing. Entolimod may also prevent side effects caused by chemotherapy with cisplatin and radiation therapy. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving entolimod together with cisplatin and radiation therapy may kill more tumor cells