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Stomatitis clinical trials

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NCT ID: NCT00728585 Withdrawn - Malignant Neoplasm Clinical Trials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: NCT00701688 Completed - Clinical trials for Hematopoietic Stem Cell Transplantation

Dose Escalation Study Of Palifermin in Pediatric Research Participants Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Start date: September 2007
Phase: Phase 1
Study type: Interventional

Mucositis is a well-known complication of both autologous and allogeneic hematopoietic stem cell transplantation (HSCT). Many who suffer this disorder require total parental nutrition and intravenous narcotics for pain control. Palifermin (Kepivance[TM]) is a human keratinocyte growth factor that is produced by recombinant DNA technology in E. coli. Palifermin is a FDA-approved, commercially available pharmacologic agent that is manufactured by Amgen. As keratinocyte growth factor receptors have been found within the epithelium of gastric mucosa, the use of palifermin has been proven to decrease the frequency and duration of severe mucositis in adult studies. Whereas the appropriate dosing regimen has been determined for adults at 60mcg/kg/day, the dosing of palifermin has not been established in the pediatric setting. This initial pediatric study of palifermin will determine the maximum tolerated dose, evaluating the use of this agent at three dose levels, below, at, and above the recommended adult dose. Non-hematologic, life-threatening NCI grade IV or grade V toxicities definitely related to the administration of palifermin from the first infusion until day +6 after HSCT (post palifermin administration day +3) will comprise the safety endpoints of the study. The study is designed to evaluate palifermin at 3 dose levels. The study population will be recipients of either a matched family member donor or matched unrelated donor HSCT. The pharmacokinetics of palifermin at each dose level will be described to help determine the appropriate dose for future studies, which will evaluate efficacy

NCT ID: NCT00699569 Not yet recruiting - Clinical trials for Head and Neck Cancer

Hyperimmune Colostrum and Oral Mucositis

Mucositis
Start date: July 2008
Phase: N/A
Study type: Interventional

To study the effect of daily intake of hyperimmune colostrum on prevention and treatment of oral mucositis in patients with head and neck cancer undergoing high-dose radiation.

NCT ID: NCT00698204 Completed - Oral Mucositis Clinical Trials

Cox-2 Inhibition in Radiation-induced Oral Mucositis

Start date: July 2003
Phase: Phase 2
Study type: Interventional

Oral mucositis refers to ulcerative lesions of the oral mucosa that occur due to radiation therapy given for treatment of head and neck cancer. These lesions are painful, compromise nutrition and quality of life and may necessitate interruptions in radiation therapy, thus adversely affecting cancer therapy outcomes. This study examined the use of an anti-inflammatory medicine to reduce pain and severity of oral mucositis.

NCT ID: NCT00626639 Active, not recruiting - Clinical trials for Head and Neck Cancer

A Study of Palifermin for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer Receiving Postoperative Radiotherapy and Concurrent Chemotherapy

Start date: July 2005
Phase: Phase 1/Phase 2
Study type: Interventional

Oral Mucositis associated with adjuvant radiation and concurrent chemotherapy in postoperative Head and Neck setting

NCT ID: NCT00615420 Completed - Clinical trials for Head and Neck Cancer

A Randomized Placebo-Controlled Trial of Manuka Honey for Oral Mucositis Due to Radiation Therapy for Cancer

Start date: July 2008
Phase: Phase 3
Study type: Interventional

The primary hypothesis of this study is that regular topical oral application of Manuka Honey will reduce the severity and duration of oral mucositis in patients who are undergoing mucotoxic radiation therapy for cancer treatment.

NCT ID: NCT00575809 Completed - Clinical trials for Peripheral Blood Stem Cell Transplantation

Incidence and Factors Associated With the Development and Severity of Oral Mucositis

Start date: May 2005
Phase:
Study type: Observational

Our study intends to evaluate prospectively the incidence and severity of oral mucositis in patients undergoing high-dose chemotherapy and hematopoietic stem cell transplantation, as well as to evaluate the potential influence of nutritional-, physical-, and transplant-related factors associated with the development of this complication and its grade of involvement.

NCT ID: NCT00574860 Terminated - Clinical trials for Head and Neck Cancer

EN3285 for the Prevention or Delay of Oral Mucositis in Patients With Head and Neck Cancer

Start date: December 2007
Phase: Phase 3
Study type: Interventional

Randomized, double-blind, placebo-controlled study for the treatment of head and neck cancer(HNC), to assess the ability of EN3285 to prevent or delay the onset of severe oral mucositis(OM).

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.

NCT ID: NCT00549952 Recruiting - Oral Mucositis Clinical Trials

Observational Study of Anti-Cancer Therapy Induced Oral Mucositis in Korean Cancer Patients

Start date: October 2007
Phase: N/A
Study type: Observational

to survey oral mucositis after chemotherapy and Concurrent chemoradiotherapy in Korean cancer patients