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Head and Neck Neoplasms clinical trials

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NCT ID: NCT01194466 Completed - Pain Clinical Trials

Transcutaneous Electrical Nerve Stimulation (TENS) and Head and Neck Cancer Pain (HNC) (TENS & HNC)

Start date: May 15, 2011
Phase: N/A
Study type: Interventional

The overall goal of this study is to examine the effect of a single dose of TENS on mucositis pain and function secondary to head and neck radiation therapies. Oral mucositis is an extremely debilitating, unpreventable condition (inflammation, ulcers, bleeding in the mouth, nose, and throat) that causes significant pain, functional impairment, and diminished quality of life. Head and neck cancers pose specific challenges to effective pain management and past studies suggest the use of effective non-pharmacologic strategies such as TENS may be particularly beneficial for avoiding sources of acute and chronic pain, thereby improving quality of life. The investigators hypothesize that a single dose of TENS will decrease pain and improve function and quality of life in head and neck cancer patients. This project is particularly innovative because it is the first known study to examine the efficacy of TENS, an established safe, inexpensive and easy-to-use non-pharmacologic pain management intervention, for treating acute oral mucositis pain. The investigators research translates bench (animal model) science to human subjects using an interdisciplinary approach to pain management. Establishing whether TENS is effective for reducing mucositis pain is a critical first step toward establishing an effective, non-pharmacologic pain relief intervention for mucositis.

NCT ID: NCT01192815 Terminated - Clinical trials for Stage IV Squamous Cell Carcinoma of the Hypopharynx

Erlotinib Hydrochloride and Radiation Therapy in Stage III-IV Squamous Cell Cancer of the Head and Neck

Start date: January 2011
Phase: Phase 2
Study type: Interventional

RATIONALE: Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Erlotinib hydrochloride may also make tumor cells more sensitive to radiation therapy. Radiation therapy uses high-energy x- rays and other types of radiation to kill tumor cells. Giving erlotinib hydrochloride together with radiation therapy may be an effective treatment for patients with head and neck cancer.PURPOSE: This phase II trial is studying how well giving erlotinib hydrochloride together with radiation therapy works in treating patients with stage III-IV squamous cell cancer of the head and neck.

NCT ID: NCT01192750 Completed - Clinical trials for Head and Neck Cancer

Biomakers in Tissue Samples From Patients With Recurrent and/or Metastatic Squamous Cell Cancer of the Head and Neck Previously Treated With Cisplatin With or Without Cetuximab

Start date: August 5, 2010
Phase: N/A
Study type: Observational

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research study is studying biomarkers in tissue samples from patients with recurrent and/or metastatic squamous cell cancer of the head and neck previously treated with cisplatin with or without cetuximab.

NCT ID: NCT01187472 Completed - Clinical trials for Head and Neck Cancer

Organ Preservation in the Multispeciality Therapy of Stage II-IV Locally Advanced Head and Neck Cancer

Start date: March 2003
Phase:
Study type: Observational

This protocol was opened to collect long term survival information on subjects enrolled in a previous study which evaluated the impact of neoadjuvant chemotherapy and concomitant chemoradiotherapy with organ preserving optional surgery on overall survival, time to progression, pattern of disease recurrence in patient with locally advanced head and neck cancer. The last surviving subject was last treated in 1989, and was lost to follow up in 2010.

NCT ID: NCT01187173 Completed - Depression Clinical Trials

The Fibrosis-Lymphedema Continuum in Head and Neck Cancer

Start date: July 2010
Phase: N/A
Study type: Observational

Goal: The primary goal of this study is to longitudinally investigate, in head and neck cancer (HNC) patients, the potential fibrosis-lymphedema continuum. Specifically, we will examine the development, patterns, progression, and prevalence of late-effect fibrosis and/or lymphedema, explore potential biological correlatives including pro-inflammatory cytokines and genetic polymorphisms, and evaluate the relationship among late-effect fibrosis and/or lymphedema and select psychosocial stressors that potentially interact with cytokine pathways. H: A minimum of 20 percent of HNC patients will experience late-effect fibrosis and/or lymphedema. H: We will be able to differentiate characteristics patterns of the development of late-effect fibrosis and/or lymphedema. H: We will be able to differentiate patterns of symptoms associated with late-effect fibrosis and/or lymphedema. H: We will be able to differentiate patterns of inflammatory response and the development of late-effect fibrosis and/or lymphedema. H: Select polymorphisms will increase the likelihood of development of late-effect fibrosis and/or lymphedema. H: Incidence and severity of late-effect fibrosis and/or lymphedema will correlate with total dose of radiation to involved anatomical site. H: HNC patients with fibrosis and/or lymphedema experience greater levels of depression and social withdrawal than those without these conditions.

NCT ID: NCT01185171 Completed - Clinical trials for Head and Neck Cancer

Trial of Induction Chemotherapy With Carboplatin and Paclitaxel, Followed by Concurrent Chemotherapy/Radiation Therapy With ZD1839 (IRESSA), 5-FU, Hydroxyurea, and Twice-Daily Radiation, Followed by Adjuvant ZD1839 Monotherapy in Patients With Locally Advanced Head & Neck Cancer

Start date: January 27, 2003
Phase: Phase 2
Study type: Interventional

The purpose of this study is to explore the activity of ZD1839 added to concurrent chemoradiotherapy and as adjuvant monotherapy in patients with locally advanced head and neck cancer. Activity is described in terms of response rate (complete responses only).

NCT ID: NCT01184482 Completed - Colorectal Cancer Clinical Trials

Lapatinib and Cetuximab in Patients With Solid Tumors

TYKERB-ITUX 1
Start date: June 2010
Phase: Phase 1
Study type: Interventional

This trial is for patients with colon cancer, head and neck cancer and lung cancer that has not responded to standard therapy. Cetuximab targets a receptor on cancer cells called the Epidermal Growth Factor Receptor or EGFR. It is thought that this receptor is turned "on" in some cancers, enabling cancer cells to divide and grow. Blocking this receptor can turn this signal off. Cetuximab blocks this receptor from the outside of cancer cells. It is thought that cancer cells can turn this signal back on by the EGFR joining with a related receptor called ErbB2. Lapatinib blocks both EGFR and ErbB2 from the inside of cancer cells. In laboratory experiments it has been found that combining drugs that target both EGFR and ErbB2 might work better in turning this signal back off. The purpose of this study is to determine the maximum dosages that patients can tolerate when these two medicines are given at the same time. In addition, in order to be on this trial, patients must agree to have a tumor biopsy before starting treatment on this study and 21 days after starting treatment. These biopsies are a required part of the study. Patients must also agree to have blood drawn for research testing to see whether genetic differences between patients explain different reactions to and side effects from, these medicines.

NCT ID: NCT01184027 Withdrawn - Surgery Clinical Trials

Impact of Nutrition and Swallowing Function of Head and Neck Cancer Patients During the Course of Treatment

Start date: October 2010
Phase: N/A
Study type: Observational

Weight loss resulting from poor food intake is common in head and neck cancer patients. Currently, feeding tubes are placed before starting treatment to provide nutrition and prevent weight loss. However, studies have not always shown that feeding tubes prevent weight loss. Also, limiting food intake by mouth may lead to swallowing problems. The aim of this study is to compare the effect of diet and swallowing therapy with feeding tube placement. In this study, your weight, food intake, swallowing ability, and side-effects of treatment will be monitored before, during, and 3 and 6 months after treatment to see if there is any difference between the therapy groups. The investigators hope that with the addition of diet and swallowing therapy during treatment that we can improve food intake and swallowing ability while still maintaining weight.

NCT ID: NCT01183065 Completed - Clinical trials for Head and Neck Cancer

Study of Pralatrexate With Vitamin B12 and Folic Acid Supplementation for Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Cancer (HNSCC)

Start date: August 2010
Phase: Phase 2
Study type: Interventional

The purpose of this study is to find out if the experimental drug pralatrexate with the vitamins folic acid and vitamin B12 might be an effective treatment for head and neck cancer. The reason we are doing this study is because another drug called methotrexate has been used for a long time to treat head and neck cancer patients. Pralatrexate was designed by scientists to be a new drug that works better than methotrexate. Laboratory studies have shown that pralatrexate works better than methotrexate at killing cancer cells. Pralatrexate has already been studied in patients with other types of cancers, such as lymphoma and lung cancer. The results from those studies were promising. Pralatrexate was recently approved by the Food and Drug Administration (FDA) as a new treatment for a cancer called peripheral T cell lymphoma.

NCT ID: NCT01179360 Completed - Clinical trials for Locally Advanced Squamous Cell Carcinoma of the Head and Neck Region

Combined FDG PET/CT Imaging in Response Evaluation After Radiochemotherapy in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)

ECLYPS
Start date: February 2011
Phase: N/A
Study type: Observational

To determine if combined [18F]fluoro-2-deoxy-D-glucose (FDG) positron emission tomography/computed tomography (PET/CT) is performant enough with respect to detecting residual lymph node involvement after chemoradiation in order to omit planned neck dissections in patients with locally advanced potentially operable, N2 and N3 head and neck squamous cell carcinoma (HNSCC). Primary study hypothesis: The lower bound of the 95% confidence interval (CI) of the negative predictive value (NPV) of FDG PET/CT to detect residual malignant lymph node involvement at 12 weeks after completing chemoradiation will exceed 85%.