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Head and Neck CancerStudy TitleA Phase II/III Study Comparing Acupuncture-like Transcutaneous Electrical Nerve Stimulation (ALTENS) Versus Pilocarpine in Treating Early Radiation-Induced Xerostomia. Prinicipal Investigators
Study NumberRTOG 0537 Status of TrialOpen Why is this study being done?The purpose of this study is to find out the effects ALTENS therapy (Acupuncture-Like Transcutaneous Electrical Nerve Stimulation) has on dry mouth (xerostomia) in patients who have been treated with radiation therapy for head and neck cancer. Dry mouth (xerostomia) is a common side effect of radiation therapy for head and neck cancer. ALTENS therapy is like acupuncture treatment, but the acupuncture points are stimulated with mild electrical stimulation without the use of needles. Currently, ALTENS therapy is not a standard treatment for radiation-induced dry mouth and is considered investigational. The ALTENS therapy will be given with a machine called a Codetron®. Although this machine has not been approved by the FDA for the treatment of dry mouth (xerostomia), it has been approved by the FDA for managing certain types of pain. There are two parts to this study. The part of the study you participate in depends on when you join the study. You will participate in Part A ContactMarilyn Robinson, CCRP Study TitleA Randomized Phase II Trial of Chemoradiotherapy versus Chemoradiotherapy and Vandetanib for High-Risk Postoperative Advanced Squamous Cell Carcinoma of the Head And Neck. Prinicipal Investigators
Study NumberRTOG 0619 Status of TrialOpen Why is this study being done?The purpose of this study is to determine whether adding vandetanib (ZactimaTMt) to the standard treatment of chemotherapy and radiation therapy is safe and tolerable. The study will compare the effects, good and/or bad, of chemoradiotherapy with chemoradiotherapy and vandetanib on you and your cancer. In this study, you will get either chemoradiotherapy or chemoradiotherapy and vandetanib. Vandetanib is an investigational agent that interferes with cell communication and growth and reduces the growth of new blood vessels. Vandetanib may delay the growth of tumor cells. This study is being done because we do not know if a combination of chemoradiotherapy with vandetanib will better control your cancer or have more or fewer side effects than chemoradiotherapy alone. This study is sponsored by the Radiation Therapy Oncology Group (RTOG). ContactMarilyn Robinson, CCRP |
