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Mucositis clinical trials

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NCT ID: NCT04151355 Recruiting - Colorectal Cancer Clinical Trials

Effect of Atorvastatin on 5-Fluorouracil Induced Mucositis

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

5-Fuorouracil (5-Fu) remains one of the most effective and most commonly used drugs to treat colorectal cancer. Mucositis is a major complication that occurs in approximately 80% of patients receiving 5-FU and results in abdominal bloating as well as vomiting and diarrhea. oral mucositis (OM) are often very painful and compromise nutrition and oral hygiene as well as increase risk for local and systemic infection. OM is characterized by an intense inflammatory reaction on the mucosa lamina propria cells, which results in activation of the transcription factor NF-kB. The activation of NF-kB leads to transcription of genes involved in the synthesis of pro-inflammatory cytokines, such as IL-1β, IL-6 and TNF-α. Agents known to attenuate the expression of cytokines have demonstrated efficacy in the prevention of experimental mucositis. The use of atorvastatin were associated with reduced production of TNF-α and IL-1β and decreased neutrophil infiltration evidenced by histopathological analysis and Myeloperoxidase (MPO) activity. In addition, atorvastatin also reduced oxidative stress and induced an increase in non-protein sulfhydryl groups showing anti-inflammatory and immunomodulatory action.

NCT ID: NCT04118335 Completed - Oral Mucositis Clinical Trials

Mulberry Syrup on Oral Mucositis Healing

Start date: March 9, 2017
Phase: N/A
Study type: Interventional

Objective: This study was carried out to investigate the effectiveness of oral care with black mulberry syrup on oral mucositis healing in individuals with COPD. Study Design: The quantitative part of the study was conducted as a randomized controlled experimental study, the qualitative section was conducted by in-depth interview method. The study was performed with 40 patients who were hospitalized in the Chest Diseases Clinic. In addition to the standard practice of the clinic, the individuals in the intervention group gargled with 5 ml black mulberry syrup and waited average one minute and then swallow it. They did this application 3 times a day after meals. 10 individuals in the intervention group were interviewed by using a semi-structured interview form.

NCT ID: NCT04110977 Recruiting - Clinical trials for Radiation Dermatitis

A Reminder App to Reduce Radiation Dermatitis Rates in Patients With Head-and-Neck Cancer

RAREST-02
Start date: October 10, 2020
Phase: N/A
Study type: Interventional

The goal of this randomized trial is to investigate whether the addition of a reminder app to standard care leads to a reduction of dermatitis and oral mucositis during radio(chemo)therapy for locally advanced squamous cell carcinoma of the head-and-neck (SCCHN). The primary endpoint is the rate of patients experiencing grade ≥2 radiation dermatitis at 60 Gy of radiotherapy. 80 patients are required per arm within the full analysis set. Taking into account that 5% of patients will not qualify for full analysis set, 168 patients should be randomized. If the addition of a reminder app to standard care will result in a significant reduction of radiation toxicity, it could become a helpful tool for these patients.

NCT ID: NCT04099901 Active, not recruiting - Multiple Myeloma Clinical Trials

Anakinra: Efficacy in the Management of Fever During Neutropenia and Mucositis in ASCT - A Randomized Controlled Trial

AFFECT-2
Start date: November 4, 2019
Phase: Phase 2
Study type: Interventional

Oral and intestinal mucositis are major risk factors for the occurrence of fever during neutropenia and bloodstream infections after intensive chemo- and radiotherapy. These complications often require dose reductions or cause delay of treatment, and thereby interfere with optimal anticancer treatment. Currently, there are no effective strategies to prevent or treat mucositis and the related complications. The pro-inflammatory cytokine interleukin-1β (IL-1β) has shown to be pivotal in the pathogenesis of mucositis and recently, it has been established in murine models that IL-1 inhibition significantly ameliorates chemotherapy-induced intestinal mucositis. The investigators recently conducted a phase IIa study (AFFECT-1, NCT03233776) studying the safety and maximum tolerated dose of anakinra, a recombinant human IL-1 receptor antagonist in adult patients with multiple myeloma receiving high-dose melphalan (HDM) in the preparation for an autologous hematopoietic stem cell transplantation (ASCT) who are at high risk for experiencing mucositis and fever during neutropenia (FN). Since treatment with anakinra has shown to be safe in this study population, the investigators will continue with a double-blind randomized placebo-controlled multicenter phase IIb trial to establish efficacy in the management of fever during neutropenia and mucositis.

NCT ID: NCT04080622 Not yet recruiting - Clinical trials for Stem Cell Transplant Complications

Evaluate the Efficacy of Selenium for the Prevention of Chemotherapy-induced Mucositis During Autologous Stem Cell Transplantation.

AutoSelenium
Start date: October 2019
Phase: Phase 3
Study type: Interventional

Chemotherapy-induced mucositis is an important complication after autologous stem cell transplantation. It is mainly responsible for pain and dysphagia requiring opioids and artificial nutrition. It can also induce infectious complications. A few medication has demonstrated efficacy in this setting. It has been suggested that selenium can reduce the intensity of mucositis due to its antioxydant activity. The investigators therefore perform a randomized study to confirm this preliminary data.

NCT ID: NCT04052373 Recruiting - Peri-Implantitis Clinical Trials

Peri-implantitis Implantoplasty Treatment

Start date: October 15, 2019
Phase: N/A
Study type: Interventional

This double arm, split-mouth, single centre, controlled, randomised clinical study is designed to examine the effect of implantoplasty in treatment of peri-implantitis. Peri-implantitis will be treated with open flap debridement, with or without implantoplasty.

NCT ID: NCT04046250 Completed - Mucositis Clinical Trials

Phase 2a Study to Evaluate Suppression of Methotrexate-induced Mucositis by TK112690

TK112690
Start date: May 15, 2019
Phase: Phase 2
Study type: Interventional

Patients will receive methotrexate at a dose of 45 mg/m2 administered weekly for 4 consecutive weeks as an iv infusion along with a nutritional supplement administered two hours before the methotrexate. One hour before the methotrexate treatment the patients will be administered the first infusion of the day of either TK112690 or placebo depending on randomization. Five hours after the methotrexate treatment the patients will be administered the second treatment of either TK112690 or placebo depending on randomization. The TK112690 dose will be 45 mg/kg.

NCT ID: NCT04042194 Completed - Peri-Implantitis Clinical Trials

Comparison of CTG and T-PRF on Peri-Implant Soft Tissue

Start date: July 1, 2018
Phase: N/A
Study type: Interventional

The present study aimed to increase the thickness of the gingiva and prevent possible crestal bone resorption by placing the CTG or T-PRF membrane under the mucosa immediately after the implant treatment in individuals with thin gingival phenotype. The null hypothesis was that T-PRF used simultaneously with implant placement can be considered an alternative to CTG.

NCT ID: NCT04003493 Completed - Oral Mucositis Clinical Trials

LifE Style, Nutrition and Oral Health in Care Givers (LENTO)

Start date: May 15, 2019
Phase: N/A
Study type: Interventional

The LENTO study sample includes the caregivers and their clients living in eastern Finland. The aims of this study are 1. to study the nutritional status, oral health, coping, functional capacity and quality of life 2. to find out how individual nutrition and oral health counseling received for caregivers affect on the nutritional status and oral health of caregivers and their clients 3. develop an operating model to maintain good nutrition and oral health.

NCT ID: NCT03998865 Completed - Clinical trials for Peri-implant Mucositis

Bacterial Microbiota Characterization on Implant-supported PEEK and Titanium Provisional Abutments

Start date: May 8, 2019
Phase: N/A
Study type: Interventional

The aim of this study is to determine the relative abundances of the different bacterial phyla and families in the microbiota present on the surface of PEEK implant-supported provisional abutments compared to titanium implant-supported provisional abutments, as well as the effect of both materials on the presence of antibiotics resistance genes.