MIT-001 for Prevention of CCRT-Induced OM in HNSCC Patients
Head and Neck Squamous Cell CarcinomaOral MucositisThe proposed study in patients with previously untreated locally advanced head and neck squamous cell carcinoma (HNSCC) is designed to evaluate the efficacy and safety of three different doses of MIT-001 compared to the placebo in prevention of oral mucositis (OM) in patients with HNSCC who are undergoing concurrent chemoradiotherapy (CCRT).
The Effectiveness of a Thyme and Honey Spray for Oral Toxicities
Cancer of the Head and NeckXerostomia2 moreAim: To evaluate the effectiveness of thymus honey on radiation induced-oral mucositis and xerostomia. Background: Oral mucositis and xerostomia are two of the most severe side effects that head and neck cancer patients confront during and after the completion of radiotherapy. Although several medications are used for their treatment, these fail to provide a fully effective and comprehensive management. Honey and thyme have been studied for the management of various treatment-related side effects. Design: Α double blinded randomised controlled trial will be used for this study. Methods: 200 head and neck cancer patients who receive radiotherapy will be included in this study. Patients will be randomised and divided into two equal groups of 100 participants; the intervention group (oral spray with thyme and honey + standard care) and the control group ( placebo spray + standard care). Assessments with xerostomia and oral mucositis scales additionally to 4 self-administered questionnaires will occur in both groups at baseline and then weekly and 6 months following completion of treatment. The duration of the study will be 3 years from the day of approval of this research protocol.
Efficacy of Glutamine in Management of Radiation Mucositis
Radiation-Induced MucositisThe goal of this [ type of study: Clinical trial] is to test effectiveness of glutamine in management of Radiation Induced Mucositis in head and neck cancer patients. The main question [s] ] is to [ learn about, test, compare etc.] it aims to answer are: Is glutamine effective in management of Radiation Induced Mucositis? Does Glutamine oral suspension affect the level of TGFβ1 in saliva of patients with radiation induced mucositis? participants will be asked to dissolve oral glutamine and maltodextrin in distalled water and swish and swallow three times daily during radiotherapy.
Use of Questionnaires and a Mucosa Topical Composition on Oncological Patients.
Quality of LifeMucositis3 morePROMs questionnaires seem to be an effective tool to obtain a greater knowledge of the physical and emotional state of patients. Despite the disparity between physicians and patient's perception, few studies have been performed with PROMs in H&N cancer patients during and after treatment. The use of a novel topical oral mucosa natural composition (Saliactive®) is studied along the use of PROMs.
Intraoral Photobiomodulation Therapy to Prevent Oral Mucositis in Patients Undergoing Hematopoietic...
Myeloablative Allogeneic Hematopoietic Cell TransplantationIntraoral Photobiomodulation Therapy2 moreThis is a single center pilot study evaluating intraoral photobiomodulation for the prevention of oral mucositis in patients undergoing myeloablative allogeneic hematopoietic cell transplantation (alloHCT). Patients who are planned for alloHCT will receive daily intraoral photobiomodulation therapy (PBMT) using a novel LED device. The name of the study device involved in this study is: - THOR LX2.3 with LED Lollipop
Protective Effect of Pentoxifylline Against Chemotherapy Induced Toxicities in Patients With Colorectal...
Colo-rectal CancerNeuropathy;Peripheral1 moreThis study aims to: - Evaluate the possible protective effect of pentoxifylline against oxaliplatin induced peripheral neuropathy and chemotherapy induced mucositis in patients with stage II and stage III colorectal cancer. This study will be a randomized placebo controlled parallel study.48 patients with colorectal cancer will be randomized to 2 groups: Group I (control group; n=24) which will receive 12 cycles of FOLFOX-6 regimen plus placebo tablets twice daily. Group II (Pentoxiphylline group; n=24) which will receive FOLFOX-6 regimen in addition to pentoxifylline 400 mg twice daily. Blood sample collection and biochemical assessment: Malondialdehyde (MDA) as oxidative stress marker (colorimetry). Tumor necrosis factor alfa (TNF-α) as pro inflammatory marker (ELISA). Neurotensin (NT) as a potential marker for neuropathic pain (ELISA). Citrulline as a biomarker for mucositis (ELISA). Clinical assessment of oxaliplatin induced neuropathy will be done through: The assessment of the severity of neuropathic pain through "Brief Pain Inventory-Short Form" at baseline and by the end of every two chemotherapy cycles. The implication of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, Version 5, 2017) for grading of neuropathy every 2 cycles. The use of Neurotoxicity- 12 item questionnaire score (Ntx-12) from the validated Functional Assessment of Cancer Therapy/Gynecologic Oncology Group at baseline and by the end of every two chemotherapy cycles). Mucositis will be assessed at baseline and by the end of every two chemotherapy cycles through the use of common terminology criteria for adverse events "CTCAE, version 5.00, 2017
Study for the Prevention of Oral Mucositis (SPOM)
Oral MucositisStudy Design Prospective, Randomized, Questionnaire-Based Study Study Type: Phase 1/Phase 2 Interventional Clinical Trial Intervention Model: Parallel Assignment Masking: None (Open-label) Actual Enrollment: 100 participants Allocation: Randomized Primary Purpose: Supportive Care/Treatment Study groups Control Group (Group 1): Saline mouthwash (±Bocaliner™) Intervention Group (Group 2): Benzydamine mouthwash (±Bocaliner™) Settings Single-center (a specialized hematology center) Location: Hematology Center after Prof. R. Yeolyan, 7 Nersisyan St, Yerevan 0014, Armenia Subjects will initially be enrolled, consented, examined, and complete initial questionnaires in the healthcare provider's office Subjects will undergo initial evaluation and follow-up examinations to determine WHO Oral Mucositis Scores Subjects will complete questionnaires at the medical center with the Research Coordinator 7 and 14 days after study enrollment. Subjects using Bocaliner™ will additionally complete a follow-up questionnaire. Application of Bocaliner™ will be carried out first at the hospital followed by self-administration at home.
Efficacy of Ulinastatin for Reducing Radiation-Induced Oral Mucositis in Nasopharyngeal Carcinoma...
Oral Mucositis (Ulcerative) Due to RadiationThis is a phase 3, open-label, multicenter, randomized controlled phase III clinical trial. The purpose of this study is to evaluate the efficacy of ulinastatin, a kind of protease inhibitor, in the treatment of radiation-induced acute oral mucositis in localregionally advanced nasopharyngeal carcinoma(NPC) patients treated with concurrent chemoradiotherapy(CCRT). To Explore a new and efficient way to reduce the incidence and severity of radiation-induced acute oral mucositis.
The Effects of Ankaferd Blood Stopper
Colon CancerOral Mucositis2 moreThe purpose of oral care is to reduce the effect of oral pathological microbial flora and to prevent infection, pain, and bleeding associated with cancer treatment. New agents are introduced each day to be used in the prevention and treatment of mucositis in cancer treatment. One of those agents is the Ankaferd Hemostat. Ankaferd Hemostat has pleiotropic effects and anti-infective characteristics in tissue healing. The aim of this study is to evaluate the effectiveness of the Ankaferd Hemostat in the prevention of oral mucositis due to chemotherapy in adult patients diagnosed with colorectal cancer. The study was designed as a randomized controlled experimental study to be conducted with patients who are recently diagnosed with colorectal cancer and will receive the first course of chemotherapyd. The data were collected using the Performance Score and the Oral Mucositis Evaluation Scale.
Ozoral Pro and Ozoral Gel vs Chlorhexidine Gel 1% for the Management of Peri-implant Mucositis Sites....
Peri-implant MucositisThis is a randomized controlled clinical trial (RCT) with a split-mouth design. After signing the informed consent, patients satisfying the inclusion criteria will undergo supragingival and subgingival professional oral hygiene of both arches performed with ultrasonic instrumentation with PEEK inserts, manual instrumentation with titanium curettes and air polishing with glycine powder. After that, the following treatment will be randomly assigned: Ozoral Pro and Ozoral gel administration and home application for 2 peri-implant mucositis sites. Curasept chlorhexidine gel 1% administration and domiciliary application for 14 days for 2 peri-implant contralateral sites. The study will last 2 years. Patients will be visited at: T0, after 1 month from T0 (T1), after 3 months (T2), after 6 months (T3), after 9 months (T4), after 12 months (T5), after 15 months (T6), after 18 months (T7), after 21 months (T8) and after 24 months (T9). For each time point, (except for T1), professional hygiene will be performed again. At each recall session, the following periodontal clinical indices were collected using a probe on each peri-implant site: BOP, GBI, conditions of the marginal mucosa (swelling and erythema), suppuration, migration of the marginal mucosa, PD, PI ,BS.