Active clinical trials for "Head and Neck Neoplasms"

The purpose of this feasibility study is to examine the effect of resistance training on muscle strength, lean body mass, physical functioning, fatigue, and quality of life in head and neck cancer patients receiving radiation therapy.

[F-18]HX4 is being developed as a diagnostic radiopharmaceutical for PET imaging. This trial is looking at the safety of [F-18]HX4. The Sponsor is seeking to determine if [F-18]HX4 may serve as a clinically useful hypoxia marker in diagnostic imaging, allowing the rational application of hypoxia related therapies to those patients most likely to benefit from them. Tumor hypoxia, a situation where tumor cells have been deprived of oxygen, caused cancer cells to become more resistant to the effects of radiotherapy and chemotherapy. A non-invasive study characterizing tumor hypoxia would facilitate the development of targeted therapies. The population to be studied consists of a total of ten (10) adult subjects, including, four normal volunteers and six cancer subjects, the latter with a confirmed diagnosis of head and neck cancer, as defined by the protocol eligibility criteria. The objectives of this exploratory study are to: Gain information on bio-distribution of [F-18]HX4, and to evaluate the PET images of [F-18]HX4 for resolution, signal to background ratio for both intermediate levels of oxygenation, and at extreme levels hypoxia Use this eIND in order to obtain the necessary information to file an IND application with the FDA. The information collected under this exploratory study will not be used for diagnostic purposes, to assess the subject's response to therapy, or for clinical management of the subject. Begin collection of baseline imaging data Collect [F-18]HX4 metabolism data Gain information to improve study design and the conduct of future trials This investigation will be conducted as an exploratory, open-label, non-randomized, uncontrolled, single center, safety study. The trial is expected to begin subject enrollment in early January 2008 and end subject participation in June 2008. The duration of an individual subject's participation includes a screening visit, followed by participation in the actual study starting with the day of dosing with imaging sessions lasting several hours, concluding with a next day safety follow-up visit. Individual doses of [F-18]HX4 shall not exceed 20 mCi. The IP will be administered through a previously placed suitably sized angiocatheter or a butterfly needle. Prior to injection, qualified site personnel will assay the dose. After IP administration several PET imaging series will be acquired. Also, in order to assess major organ function and electrolyte levels, a metabolites analysis will be performed for this study from predose to 90 minutes postdose. In order to determine the quantity of [F-18]HX4 and labeled metabolites excreted by the kidney,urine will be collected and pooled at the designated intervals after administration of the investigational product. This excretion data will provide supportive information for calculating human dosimetry estimates from PET imaging biodistribution data collected in human subjects. For cancer subjects, a tissue biopsy will have been taken or be scheduled to be performed. The biopsy sample will be examined for hypoxic biomarker(s) using immunohistochemistry methods.

The purpose of this study is to evaluate a new rubber material used to make prosthetic replacements of the face lost to cancer, trauma, or birth defects.

RATIONALE: Moving a salivary gland out of the area that will undergo radiation therapy may protect the gland from side effects of radiation therapy and may prevent xerostomia (dry mouth). PURPOSE: Phase II trial to study the effectiveness of salivary gland surgery in preventing xerostomia in patients who are undergoing radiation therapy for head and neck cancer.

RATIONALE: Sargramostim may lessen symptoms of mucositis in patients receiving radiation therapy for head and neck cancer. It is not yet known if sargramostim is more effective than no treatment in reducing mucositis caused by radiation therapy. PURPOSE: Randomized phase III trial to determine the effectiveness of sargramostim in decreasing mucositis in patients who are receiving radiation therapy for head and neck cancer.

The goal of this clinical trial is to learn about the clinical efficacy of San-Zhong-Kui-Jian-Tang (SZKJT), a formula of Chinese medicine in head and neck cancer patients receiving concurrent chemoradiotherapy (CCRT) treatments. The main questions it aims to answer are: Can SZKJT improve the completion rate of CCRT? Can SZKJT reduce the adverse effects of CCRT? How SZKJT affect the quality of life in the patients receiving CCRT How about the safety of using SZKJT in the patients receiving CCRT Participants will be asked to: take SZKJT for 9 weeks during the whole CCRT course take questionnaires of quality of life

Patient-reported information on outcomes such as symptom-burden and health-related quality of life (QoL) is regarded as a useful tool to improve quality of care in clinical cancer research. However, integrating patient-reported information in the routine clinical practice is often difficult due to excessive time use and practical barriers. Electronic data acquisitions, where the treating physician has immediately access to the patient-reported data in the subsequent consultation, have been shown to be beneficial in the everyday clinical decision making. The aim of this study is to develop and test a computer-based patient-reported assessment tool that will assist the clinicians in tracking long term and late effects in head and neck cancer patients and investigate if the tool leads to improved symptom assessment of a range of head and neck cancer specific symptoms, which again may lead to improved symptom control and enhanced quality of life in the patients. Patients with a diagnosis of head and neck cancer attending the oncology outpatient clinics at Herlev Hospital and physicians and nurses who work at the clinic will be invited to participate. The assessment tool will be developed with inspiration from prior international studies of symptom assessment in head and neck cancer patients and tailored so that it will fit into a Danish context. The tool will be tested in a controlled intervention study. In the intervention group, patients will complete the assessment tool in the patients waiting area prior to every scheduled consultation. The result will then be printed and provided to the treating physician. In the control group, the patients will complete the assessment tool prior to consultations. However, the data will not be provided to the physicians at any time. To assess the impact of the tool on number of symptoms addressed during consultations and patients' overall quality of life, medical records will be reviewed for before start of intervention and again at 6 and 12 months follow-up. The patients will also complete the EORTC QLQ-C30 and the EORTC QLQ-H&N35 at baseline and at 6 and 12 months follow-up. Furthermore, we will conduct a qualitative evaluation (semi structured interview and participant observations) of attitudes among clinicians and patients regarding the use of tool at the point of care.

Oral Mucositis (OM) is a painful and debilitating side effect of many of the drug/radiation regimens used to treat cancer. This study examines the investigational drug brilacidin and its possible application in prevention of oral mucositis in patients undergoing chemoradiation for treatment of head and neck cancer.

This pilot clinical trial studies a pain management smartphone application for monitoring pain in patients with locally advanced head and neck cancer who are undergoing radiation therapy. The study is also open to patients with esophageal or lung cancer. A smartphone application may allow patients to assess their symptoms in a manner that is closer to real-time than having to recall pain episodes during once weekly on-treatment visits with a health care provider. This real-time monitoring may improve the timing and efficacy of interventions leading to better pain-control and quality of life.

The purpose of this study is to explore whether early initiated physical exercise concurrent with a swallowing and mouth opening exercise program will have a positive effect on swallowing function and other quality of life aspects in patients treated with radiotherapy for head and neck cancer. The investigators hypothesize that patients who complete the program will have improved swallowing function and physical function one year after completing their treatment compared to patients who do not participate in the training program.