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Oral Mucositis clinical trials

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NCT ID: NCT01036633 Completed - Oral Mucositis Clinical Trials

Oral Mucositis in Patients Undergoing Antineoplastic Chemotherapy

Mucositis
Start date: August 2009
Phase: N/A
Study type: Observational

The purpose of this study was to: 1. To investigate the feasibility of using infrared (IR) thermometer to grade the severity of oral mucositis in patients with multiple myeloma undergoing chemotherapy. 2. To obtain preliminary data on the most optimal method of scoring the severity of oral mucositis by comparing the results obtained using the IR thermometer to the World Health Organization (WHO) mucositis grading system and the patient self-assessment questionnaire. 3. To Investigate the correlation between the quantitative readings obtained from oral mucosa with the IR thermometer.

NCT ID: NCT00965172 Completed - Sarcoma Clinical Trials

Caphosol in Sarcoma Patients With Mucositis

Start date: April 2010
Phase: Phase 2
Study type: Interventional

The goal of this clinical research study is to find out if Caphosol® (calcium phosphate) mouthwash is more effective than a baking soda solution at preventing and treating mucositis, in patients with sarcoma who are to be treated with chemotherapy. The safety of this drug will also be studied. Researchers also want to learn about the way calcium phosphate may affect mucous membranes. The goal of this clinical research study is to see if Caphosol® (calcium phosphate) mouthwash is better than baking soda solution in patients with sarcoma who are to be treated with chemotherapy . Caphosol will also be studied to see if it lessens the incidence and severity of oral mucositis (painful sores in the mouth).

NCT ID: NCT00938080 Completed - Oral Mucositis Clinical Trials

Study to Assess Safety and Tolerability of AG013 in Oral Mucositis in Subjects Receiving Induction Chemotherapy for the Treatment of Cancers of the Head and Neck

Start date: September 2009
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety and tolerability of AG013 (genetically modified L. lactis bacteria engineered to secrete human Trefoil Factor 1), and to explore the ability of AG013 to attenuate the course and severity of oral mucositis (OM) in subjects receiving induction chemotherapy for the treatment of head and neck cancer.

NCT ID: NCT00845819 Completed - Oral Mucositis Clinical Trials

Study of Epidermal Growth Factor on Oral Mucositis Induced by Intensive Chemotherapy for Hematologic Malignancies

EGFOM
Start date: February 2009
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine efficacy and toxicity of recombinant human epidermal growth factor (rhEGF) as a preventive drug of oral mucositis during intensive chemotherapy with stem cell transplantation in patients with hematologic malignancies.

NCT ID: NCT00804817 Completed - Malnutrition Clinical Trials

Somatic-psychosocial Care Concept for Oncologic Patients Undergoing Hematopoietic Stem Cell Transplantation (HSCT)

Start date: December 2007
Phase: N/A
Study type: Interventional

This study will test the SCION (Self care improvement through oncology nursing)-HSCT program a multi-modular, somatic-psycho-social care intervention to improve self management in oncologic patients undergoing HSCT. The study will determine if the self management skills of the patients to enhance: - physical activity, - prevention of oral mucositis and - mal nutrition during the period of hospitalization. It is hypothesized that patients who receive the multi-modular somatic-psycho-social care intervention will have better health related quality of life (HRQoL).

NCT ID: NCT00790322 Completed - Clinical trials for Head and Neck Cancer

Efficacy and Safety Study of SBG vs Placebo in Head and Neck Cancer Patients Undergoing Radiation Therapy

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

The purpose of this study is to evaluate the efficacy and safety of SBG vs placebo on oral mucositis in head and neck cancer patients undergoing radiation therapy.

NCT ID: NCT00756951 Completed - Clinical trials for Head and Neck Cancer

Dose Ranging Study to Assess the Safety and Efficacy of SCV-07 for the Delay to Onset of Severe Oral Mucositis in Patients Receiving Chemoradiation Therapy for Head and Neck Cancer

SCV-07 OM
Start date: September 2008
Phase: Phase 2
Study type: Interventional

Oral Mucositis (OM) is a painful and debilitating side effect of many of the drug or radiation regiments used to treat cancer. This study examines the investigational drug SCV-07 and it's possible application in treating Oral Mucositis. Studies have shown that SCV-07 can possibly increase a broad immune system response, thus lowering the painful side effects experienced when treated for head and neck cancer. The purpose of this study is to assess the safety and tolerability of SCV-07 and it's ability to delay the onset of Oral Mucositis for patients receiving chemoradiation for head and neck cancer.

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: 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: NCT00385515 Completed - Oral Mucositis Clinical Trials

Efficacy of SNX-1012 in the Treatment of Oral Mucositis

Start date: June 2006
Phase: Phase 2
Study type: Interventional

Oral mucositis (OM) is a common and debilitating toxicity induced by many chemotherapy (CT) regimens and by radiation to the head and neck. The purpose of this study is to determine the effectiveness of SNX-1012 in decreasing the duration of Grade 2, 3, or 4 oral mucositis (OM) according to World Health Organization (WHO) criteria.