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.
Feasibility Study of Dynasplint to Prevent Trismus in Head and Neck Cancer
TrismusHead and Neck CancerThe purpose of this study is to see if use of a device called the Jaw Dynasplint® System can be used during and immediately after cancer treatment. The Dynasplint® is a stretching device that is used to treat joint stiffness and limited range of motion in the jaw. The device is currently approved for treatment of trismus once it has developed. This study will investigate the use of the device during and immediately after cancer treatment to prevent trismus.
Characterization of Head and Neck Malignant Tumors Using an Electronic Nose
Head and Neck CancerHead and neck tumors are common in the general population especially in high risk groups of smokers and alcohol abusers, as well as after exposure to various environmental factors. Diagnosis is based on identification of patients gross disease after a physical examination and various imaging methods, and characterization of tissue mainly by fine-needle puncture (FNA) and biopsy. Determining the stage of disease is based on physical examination, imaging and tissue samples. Using the electronic nose technology we hope to identify microscopic disease when it is suspected or in populations in risk, thus diagnose patients in the initial stages of the disease. Obviously, early diagnosis and treatment decisions will hopefully improve the prognosis. Finding a positive correlation between the stages, levels and various tumor volume and respiratory specimens findings will classify patients more accurately and contribute to further characterization of the disease in a more accurate, rapid and non-invasive fashion.
Treatment and Prevention of Middle Ear Morbidity in Head and Neck Cancer Patients Following Radiotherapy...
Otitis Media With EffusionChronic Otitis Media1 moreTo investigate the incidence of tuba dysfunction (TD) and middle ear (ME) morbidity after radiotherapy (RT) to the Head & Neck and test the effect of auto-inflation of the Eustachian tube (ET) on middle ear effusion with a special designed balloon (Otovent®) and thereby better hearing and ear related quality of life after cancer treatment.
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)
Trial of BMX-001 or Placebo in Head and Neck Cancer Patients
Head and Neck CancerThere are an estimated 65,000 newly diagnosed cases of head and neck cancer each year in the United States. The most common treatment for head and neck cancers is radiotherapy in combination with cisplatin chemotherapy. This treatment regimen is effective in killing the tumor; however, the normal tissues that line the mouth and throat can sustain severe injury from the radiation. Side-effects incurred during irradiation include: mucositis, xerostomia, swelling, trouble swallowing, pain, infections, cavities, hair loss and reddening of the skin. Some of these side effects can be so severe that patients require feeding tubes and management of severe pain can lead to the premature halt of radiotherapy. There are currently no effective radio-protectors used to ameliorate these severe side-effects. BioMimetix has developed small molecular weight superoxide dismutase (SOD) mimetic, BMX-001, that is a very potent radio-protector of head and neck tissues. In our first clinical trial in a head and neck cancer patient cohort using this drug, we have early evidence that BMX-001 may protect against radiation-induced mucositis and xerostomia. This will be a randomized, placebo-controlled Phase 2 clinical trial to study the effects of BMX-001 (14 mg/subject biw) + radiation therapy + cisplatin against placebo + radiation therapy + cisplatin in prevention of acute and chronic mucositis and xerostomia.
Endodontic-Restorative Pre-Radiation Therapy of Head and Neck Cancer Patients
Pulpitis - IrreversibleCaries1 morePilot study involving 20 patients undergoing dental treatment prior to radiation therapy. Comparison of outcome parameters to existing data of age and gender matched patients.
AMD3100 Plus Pembrolizumab in Immune Checkpoint Blockade Refractory Head and Neck Squamous Cell...
Head and Neck CancerThis research is studying the safety and effectiveness of AMD3100 and pembrolizumab in participants with metastatic head and neck squamous cell carcinoma.
Everolimus, Erlotinib Hydrochloride, and Radiation Therapy in Treating Patients With Recurrent Head...
Recurrent Metastatic Squamous Neck Cancer With Occult PrimaryRecurrent Salivary Gland Cancer9 moreThis phase I trial studies the side effects and best dose of giving everolimus (RAD001) and erlotinib hydrochloride together with radiation therapy in treating patients with recurrent head and neck cancer previously treated with radiation therapy. RAD001 and erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x rays to kill tumor cells. Giving RAD001 and erlotinib hydrochloride together with radiation therapy may kill more tumor cells.
F-18 Fluorothymidine PET Imaging for Early Evaluation of Response to Therapy in Head & Neck Cancer...
Mouth NeoplasmsOropharyngeal Neoplasms2 moreThis is an imaging protocol only, not a therapeutic study. The primary goal of the proposed study is to examine the utility of a new imaging study, Positron Emission Tomography with F-18 Fluorothymidine (FLT PET), in the early treatment evaluation of head and neck cancer. FLT uptake in the tumor correlates with the rate of cell proliferation. It is therefore hoped that changes in tumor FLT uptake after therapy will reflect change in the number of actively dividing tumor cells and will provide early assessment of treatment response. Research subjects will undergo one PET scan with FLT. The scan is done prior to any therapeutic intervention (radiation or chemotherapy) can be obtained up to 30 days prior to the start of therapy. The uptake of FLT in the tumor will be analyzed to see if it can be used as a predictor of treatment efficacy and/or outcome. There is an optional biopsy component to this study. Should the attending physicians (primarily the otolaryngologists) believe that the subject can safely undergo an outpatient biopsy, and the subject agrees, a biopsy is performed. The biopsy will be done within 30 days prior to treatment, similar to FLT PET scans. Tissue from the biopsy will be analyzed for markers of cellular proliferation and these markers will be correlated with the findings of FLT PET scan. There will be a 2-year clinical follow-up to assess for treatment outcomes, local control, and overall survival.