A Study to Assess the Impact of a Non-SLS Toothpaste Upon Oral Mucosal Desquamation
Sloughing SkinMucosal InflammationThis study is to compare the effect on oral mucosal desquamation of a non-SLS toothpaste and an SLS-containing toothpaste..
Feasibility and Safety of CareMin650 in Patients at Risk of or Suffering From Oral Mucositis and/or...
Oral Mucositis Due to RadiationRadiation DermatitisThe main objective of the present study is to investigate the feasibility, safety and tolerability of CareMin650 in patients with 1) head & neck cancer at high risk of or suffering from oral mucositis and/or radiation dermatitis due to the administration of radiotherapy with or without chemotherapy with or without targeted therapy, 2) breast cancer at high risk of or suffering from radiation dermatitis due to the administration of radiotherapy.
Feasibility Study of a Nurse Intervention to Impact Mucositis Severity and Prevent Dehydration
Lung CancerMucositis Oral2 moreThis is a descriptive mixed method pilot study to determine the feasibility of a tailored nurse-delivered telephone intervention designed to impact mucositis symptom severity and prevent dehydration in lung and head/neck cancer patients undergoing chemoradiation, therefore reducing overall symptom severity and improving quality of life. Secondary purposes for this study are to investigate if the nursing intervention can decrease lung and head/neck cancer patients' unscheduled medical visits between chemoradiation treatments.
Ability of Curcumin to Decrease Cytokines Involved in Mucositis in the Autologous Transplant
Oral Mucositis (Ulcerative)Mucositis is a very common complication in bone marrow transplant setting. It is a result of injury to the gut caused by high dose chemotherapy. Currently there are no universal protocols that have been accepted as a standard to prevent and treat mucositis in the transplant setting. Post transplant upto 80% of patients suffer from a severe mucositis. Proinflammatory cytokines play a major role in the development of mucositis. Interventions that decrease the levels of these cytokines may be beneficial in preventing mucositis. This study is aimed at evaluating the role of curcumin in reducing cytokine levels and the incidence and duration of mucositis in patients undergoing autologous stem cell transplantation.
Impact of Contraceptives on Cervico-Vaginal Mucosa
Mucosal InflammationContraceptive; Complications1 moreUMPALA is a research study to look at the effect of four different, approved contraceptives on the cervical and vaginal tissues as well as on factors in the blood. Participants will have a baseline examination then receive one of four approved, marketed contraceptive products. Cervico-vaginal assessments will take place 4 weeks after contraceptive initiation and 3 months after to assess changes in mucosal safety after use of various contraceptive products in young, healthy, HIV uninfected women.
Analgesic Effects of Topical Ketamine Mouthwash in Patients Receiving Chemoradiation or Radiotherapy...
MucositisHead and Neck CancerThe primary objective is to determine the reduction in pain score by ketamine mouthwash compared to placebo in head and neck cancer patients with refractory mucositis. The secondary objectives are to describe the duration of analgesia and adverse effects associated with ketamine and placebo.
A Study of the Effects of GC4419 on Radiation Induced Oral Mucositis in Patients With Head/Neck...
Radiation Induced Oral MucositisThe purpose of the phase 2, GT-201 clinical study is to determine if GC4419 administered prior to intensity-modulated radiation therapy (IMRT) reduces the incidence, duration, and severity of radiation induced oral mucositis in patients who have been diagnosed with locally advanced, non-metastatic squamous cell carcinoma of the head and neck.
L-lysine in Treating Oral Mucositis in Patients Undergoing Radiation Therapy With or Without Chemotherapy...
MucositisOral Complications of Chemotherapy66 moreThis pilot clinical trial studies L-lysine in treating oral mucositis in patients undergoing radiation therapy with or without chemotherapy for head and neck cancer. L-lysine may lessen the severity of oral mucositis, or mouth sores in patients receiving radiation therapy with or without chemotherapy for head and neck cancer
Caphosol in Oral Mucositis Due to Targeted Therapy
Oral ComplaintsRenal Cell Carcinoma2 moreTargeted therapies such as multi-targeted tyrosine kinase inhibitors (TKI) and mammalian target of rapamycin inhibitors (mTORI) in renal cell carcinoma (RCC), demonstrate a high level of efficacy with acceptable tolerability. Currently, there are five approved targeted therapies available for RCC: sunitinib (Sutent®), sorafenib (Nexavar®), pazopanib (Votrient®), temsirolimus (Torisel®), and everolimus (Afinitor®). Hepatocellular carcinoma treated with sorafenib and gastro intestinal stromal tumors patients treated with sunitinib will be included, too. Since this agents have dermatological adverse events in common, with oral mucositis (OM), hand-foot skin reaction (HFSR) and papulopustular eruption (PPE) as an disabling side effect, we require evidence based management options to prevent and treat these adverse events. The incidence of OM of any grade is for sunitinib 38%, sorafenib 28%, pazopanib 4%, temsirolimus 41%, and everolimus 44%. Recent data suggest that TKI and mTORI associated OM is distinct from conventional mucositis and more closely resembles aphthous OM. Recently, supersaturated calcium-phosphate rinse (Caphosol®), a Ca2+/PO43- mouth rinse, became available to prevent or treat OM. The objective is to assess the relieving effect of Caphosol® oral rinse on clinical outcomes which include oral intake, swallowing function and pain associated with incidence of grade ≥ 1 oral side effects and the anticancer therapy cessation in patients treated with selected targeted anticancer therapy. Patients with OM > grade 0 on targeted therapy will be randomly allocated to receive either Caphosol® or NaCl 0.9% rinse for two weeks. After the first rinse period all patients will switch to the opposite treatment arm (NaCl 0.9% or Caphosol®) for another two weeks. Duration of oral side effects, severity, pain, dose of analgesics and tolerability will be assessed weekly with the Modified-VHNSS-version-2.0 oral-specific questionnaire. Patients will be stratified by targeted anticancer agent and per tumor type (pre-defined cohorts). Objective severity of oral side effects will be assessed using the NCI-CTCAE v4.0. Correlation of subjective Modified-VHNSS-version-2.0 scores with the objective NCI-CTCAE grade, sex, age, targeted therapy type, and cancer type will be conducted.
Melphalan and Palifermin in Treating Patients Undergoing An Autologous Peripheral Stem Cell Transplant...
MucositisMultiple MyelomaRATIONALE: Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Keratinocyte growth factors, such as palifermin, may help prevent symptoms of mucositis, or mouth sores, in patients receiving melphalan before a peripheral stem cell transplant for multiple myeloma. PURPOSE: This phase I trial is studying the side effects and best dose of melphalan when given together with palifermin in treating patients undergoing an autologous peripheral stem cell transplant for stage II or stage III multiple myeloma.