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Stomatitis 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NCT ID: NCT05331131 Withdrawn - Clinical trials for Cancer of Head and Neck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: 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: NCT02535962 Withdrawn - Pharyngitis Clinical Trials

Probiotics and Corticosteroids for Treating Periodic Fever, Aphthous Stomatitis, Pharyngitis, Cervical Adenitis (PFAPA)

PFAPA
Start date: October 2016
Phase: Phase 2
Study type: Interventional

The purpose of study is to see if adding probiotics to corticosteroid treatment for children with PFAPA could improve the health and daily of patients through reduction in febrile period frequency and length, along with concomitant reduction of associated symptoms. Current standard of care incorporates the administration of corticosteroids; however, while limiting the symptoms associated with PFAPA, corticosteroid use has been shown to increase the frequency at which these symptoms occur. Investigators hypothesize that administration of probiotics along with corticosteroids will work to decrease the frequency at which the febrile episodes occur. Additionally, probiotics may decrease the maximal fever experienced during these episodes, amount of corticosteroid needed to control the symptoms, average length of the episodes, and the number of patients who ultimately undergo tonsillectomy due to unsuccessful treatment with medication.

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: NCT01545687 Withdrawn - Pain Clinical Trials

CD2 Lozenges in Preventing Acute Oral Mucositis in Patients With Head and Neck Cancer Receiving Radiotherapy and Chemotherapy

Start date: April 2012
Phase: Phase 3
Study type: Interventional

RATIONALE: Lactobacillus bevis CD2 lozenge may help prevent symptoms of mucositis, or mouth sores, in patients receiving radiation therapy and chemotherapy. This therapy may improve the quality of life of patients with head and neck cancer. PURPOSE: This phase III trial studies how well Lactobacillus bevis CD2 lozenge prevents oral mucositis in patients with head and neck cancer who are being treated with cisplatin and radiation therapy. These results will be compared to results in patients using placebo lozenges.

NCT ID: NCT01288625 Withdrawn - Oral Mucositis Clinical Trials

Prospective Study of Head and Neck Cancer Radiation Treatment With or Without Amifostine

Start date: n/a
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare the incidence of stomatitis when treating with amifostine before radiation treatment.

NCT ID: NCT00728585 Withdrawn - Malignant Neoplasm Clinical Trials

Palifermin in Preventing Oral Mucositis Caused by Chemotherapy and/or Radiation Therapy in Young Patients Undergoing Stem Cell Transplant

Start date: March 13, 2008
Phase: Phase 2
Study type: Interventional

This randomized phase II trial is studying palifermin to see how well it works compared with a placebo in preventing oral mucositis caused by chemotherapy and/or radiation therapy in young patients undergoing stem cell transplant. Palifermin may help relieve or prevent oral mucositis caused by chemotherapy and radiation therapy in young patients undergoing stem cell transplant.

NCT ID: NCT00556686 Withdrawn - Canker Sore Clinical Trials

Salivary Catecholamines in Aphthous Stomatitis (Canker Sores)

Start date: August 2006
Phase: N/A
Study type: Observational

The purpose of this study is to examine how compounds produced in patients with canker sores affect wound healing.