Comparison of the Effectiveness of Three Different Gargates in Radiotherapy-Associated Oral Mucositis...
Head and Neck CancersOral MucositisThis study was conducted to compare the effectiveness of thyme honey, saline and sodium bicarbonate solution in the management of oral mucositis in patients with head and neck cancer receiving radiotherapy.
A Trial of a Botanical Drug Containing East Indian Sandalwood Oil (EISO) for the Treatment of Oral...
Oral MucositisThe initial proposed clinical study will be conducted in adult head and neck cancer subjects. This will be an open-labeled, proof of concept trial to evaluate the efficacy, safety and tolerability of EISO in a form of oral rinse as adjunctive therapy to standard of care. Santalis believes that the proposed study is a prudent and appropriate approach to investigate the potential of their product to prevent or improve oral mucositis symptoms commonly seen in subjects undergoing radiotherapy with or without chemotherapy.
Clinical Trial on the Efficacy and Safety of Chining Decoction in the Treatment of Radiation Stomatitis...
Head and Neck CancerThis study evaluates the efficiency and safety of ChiNing decoction to head and neck cancer patients with radioactive stomatitis. Half of participants will receive ChiNing decoction, while others will receive recombinant human epidermal growth factor (rhEGF) spray.
Cryoprotection of Chemotherapy-induced Oral Mucositis After Autologous Stem Cell Transplantation,...
Cryotherapy EffectThis study evaluates, among study patients with lymphoma or myeloma undergoing autologous SCT, whether cooling oral mucosa with a cooling device compared with ice cubes/crushed ice or ice pop succeeds in reducing the degree of oral mucositis (OM) according to the Oral Mucositis Assessment Scale (OMAS) total,degree of OM according to World Health Organisation (WHO), tolerability of either cooling method. The study is also aiming to , patients subjective experience of OM, rating of general quality of life and oral pain, number of days with total parenteral nutrition (TPN), number of hospital days, total dose of opioids, and C reactive protein during time in care. Finally, the study aims to evaluate weight loss, Leukocyte particle concentration, number of days until bone marrow response, S-albumin, and body temperature.
Ph 2 Open Label Study of GC4419 to Reduce SOM Associated With Chemoradiotherapy for Head and Neck...
Head and Neck CancerOral MucositisGTI-4419-202 is a Phase 2 open-label study of the effects of GC4419 (IV) when administered in combination with IMRT and cisplatin to up to subjects with head and neck cancer, who are at high risk for Severe Oral Mucositis (SOM)
Phototherapy for the Management of Oral Ulcers in Bone Marrow Recipients
Oral Mucosal UlcerationOral Mucositis1 moreStudy hypothesis: light therapy may prevent oral ulcers in bone marrow recipients. Methods: patients will be treated with either active light-emitting device or inactive light-emitting device. Daily treatment with light therapy will start at the beginning of the conditioning regimen and will last until day 21 post-transplant. Each daily treatment last about 5 minutes. Patients will be evaluated for oral mucositis and oral pain level on a weekly basis.
Comparative Trial of Cryotherapy Versus Caphosol Versus Saline Solution Mouth Washes for the Prevention...
MucositisMultiple MyelomaChemotherapy-induced oral mucositis is the inflammation of the oral mucous membranes, which are tissues that line the mouth. Oral mucositis is caused when chemotherapy attacks and kills the rapidly-dividing cells in the oral mucous membranes. This condition feels like sunburn (or heartburn) on the mucous tissues, and often leads to sores in the mouth or on the tongue. This can cause discomfort, pain, difficulties in eating, and a longer hospital stay. Several therapies appear to either prevent or reduce the severity of mouth ulcers caused by chemotherapy for multiple myeloma. Different strategies are used to try and prevent this condition; a small number of trials found that some of these strategies may be effective. None of the trials had compared head to head the use of saline solution (our standard of care), cryotherapy (ice chips) and Caphosol in patients receiving high-dose melphalan. The goal of this research study to evaluate the effectiveness of saline solution, cryotherapy, Caphosol for the prevention of oral mucositis in patients with multiple myeloma receiving high-dose chemotherapy followed by autologous hematopoietic stem cell transplantation. The researchers hope to learn if there are any differences among saline solution, cryotherapy and Caphosol mouth rinse for the prevention of oral mucositis.
Evaluate PKs and Efficacy Assessment of Palifermin in Patients With Sarcoma
SarcomaOral MucositisPrimary: To evaluate the preliminary efficacy of palifermin in reducing the incidence and severity of oral mucositis (OM) in patients with sarcoma receiving multicycle chemotherapy. To evaluate the pharmacokinetics (PK) of palifermin when given pre chemotherapy. To evaluate the safety profile of palifermin when combined with multicycle chemotherapy. Exploratory: To evaluate the biologic effect of palifermin on oral mucosa. To investigate potential biomarker development by biochemical analysis in blood cells, serum, and plasma. To investigate the effects of genetic variation in mucositis genes, drug metabolism genes, and drug target genes on patient response to the treatment regimen.
Tocopherol is a Novel Treatment for Cancer Related Mucositis
Oral MucositisThe present protocol is an attempt to prevent/treat mucositis in highly susceptible patients subjected to maximally tolerated doses of subsequently-myeloablative or myeloablative doses of chemoradiotherapy supported by autologous or allogeneic stem cell transplantation at the Department of Bone Marrow Transplantation. Mucositis is a major problem in the management of transplant recipients which subjects the patients to the risk of sepsis, need for parenteral nutrition and need of narcotics. We are planning a 2 arm study, comparing 2 safe vitamin E based formulations with placebo.
Prevention of Oral Mucositis Using Photobiomodulation Therapy
Oral MucositisOral mucositis is a significant and common toxicity experienced by patients who receive high-dose chemotherapy as a preparatory regimen for a hematopoietic cell transplant (HCT). Furthermore, oral mucositis has been reported as the single most debilitating side effect reported by patients undergoing HCT. The incidence of HCT mucositis among adults is estimated to range between 76% and 89%; however, comparisons are difficult due to variability in patient ages, treatments and criteria for scoring oral mucositis. The use of intra-oral photobiomodulation (PBM) therapy in adult patients after the development of oral mucositis is well documented and now included in the international mucositis guidelines, with limited evidence in pediatrics. This study will build evidence for the incorporation of extra-oral PBM therapy into daily nursing care of children and adolescents undergoing HCT. This intervention has potential in providing evidence for efficacy in the prevention and treatment of oral mucositis, the single most debilitating side effect reported by patients undergoing HCT. Primary Objective: To evaluate feasibility and efficacy of photobiomodulation therapy (PBM) in reducing oral mucositis in children and adolescents at risk for grade 3 oral mucositis undergoing an allogeneic hematopoietic cell transplant (HCT). Secondary Objective: To compare clinical manifestations associated with the development of oral mucositis between those treated with daily PBM and a matched control. Clinical factors to include: grade and duration or oral mucositis. Exploratory Objective: To evaluate efficacy of photobiomodulation therapy in autologous patients at risk for grade 3 oral mucositis compared to matched control. To evaluate utilization of play-based procedural preparation and treatment feasibility and parental satisfaction.