Active clinical trials for "Head and Neck Neoplasms"

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells, but may cause skin irritation and inflammation. Biafine cream may be effective in lessening side effects caused by radiation therapy. PURPOSE: Randomized phase III trial to determine the effectiveness of Biafine cream in reducing side effects of radiation therapy in patients receiving treatment for head and neck cancer.

Avmacol is an over-the-counter dietary supplement containing broccoli seed and sprout extracts in tablet form, hypothesized to activate protective cellular pathways including detoxication. In this study, participants who have been curatively treatment for head and neck cancer, will take Avmacol twice a day for 3 months.

This randomized control trial aims to investigate the efficacy of oral moisturizing jelly in head and neck cancer patients with xerostomia.

This study will aim to demonstrate that implementation of a rapid, multidisciplinary supportive care program for patients receiving chemoradiotherapy who are deemed to be at high risk for hospitalization based on real-time pedometer data will reduce the rate of hospitalization during chemoradiotherapy or within four weeks of radiotherapy completion.

This study aimed to investigate the effects of progressive muscle relaxation (PMR) on postoperative pain, fatigue, and vital signs in patients with head and neck cancers.

The purpose of this study is to determine whether a brief couple-based supportive intervention effectively assists patients and their partners coping with the challenges of head and neck cancer.

Research on physical activity and nutrition interventions aimed at positively impacting symptom management, treatment-related recovery and quality of life has largely excluded head and neck cancer populations. This translates into a lack of clinical programming available for these patient populations. Head and neck cancer patients deal with severe weight loss, with upwards of 70% attributed to lean muscle wasting, leading to extended recovery times, decreased quality of life (QoL), and impaired physical functioning. To date, interventions to address body composition issues have focused solely on diet, despite findings that nutritional therapy alone is insufficient to mitigate changes. A combined physical activity and nutrition intervention, that also incorporates important educational components known to positively impact behaviour change, is warranted for this population. Pilot work suggests that there is large patient demand and clinic support from the health care professionals for a comprehensive program. Therefore, the purpose of the present study is to examine the impact of timing of a 12-week PA and nutrition intervention (either during or following treatment) for HN cancer patients on body composition, recovery, serum inflammatory markers and quality of life. In addition, the investigators will examine the impact of a 12-week maintenance program, delivered immediately following the intervention, on adherence, patient-reported outcomes (i.e., management of both physical and psychosocial treatment-related symptoms and side-effects), as well as return to work. The investigators hypothesize that (1) patients who are randomized to the intervention at treatment start will experience improved symptom management and decreased lean body composition changes, directly improving recovery and QoL; (2) patients who receive a maintenance support program will have better long-term adherence and therefore superior treatment-related symptom management, physical and psychosocial functioning; and (3) return to work indices will improve and healthcare utilization costs will be lower in the participants who receive the immediate intervention (vs. delayed) as well as in those who receive the maintenance program (vs. no maintenance). This research will facilitate advancements in patient wellness, survivorship, and autonomy, and carve the path for a physical activity and wellness education model that can be implemented in other cancer centers.

This randomized pilot clinical trial studies body warming in improving blood flow and oxygen delivery to tumors in patients with cancer. Heating tumor cells to several degrees above normal body temperature may kill tumor cells.

The primary goal of this study is to evaluate the safety of a transcription factor decoy targeting Signal Transducer and Activator of Transcription 3(STAT3) in patients with head and neck cancer. The rationale for targeting STAT3 using this approach is to decrease STAT3-mediated gene regulation. The study has the following scientific objectives: To assess the safety of a single dose of intratumoral STAT3 decoy. To estimate the effect of STAT3 decoy therapy on STAT3 activation levels, STAT3-mediated gene expression, and apoptosis in treated tumors.

[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.