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Head and Neck Neoplasms clinical trials

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NCT ID: NCT02854358 Completed - Xerostomia Clinical Trials

Efficacy of Traditional Persian Medicine Preparation Versus Artificial Saliva for Radiation Induced Xerostomia

Start date: March 2015
Phase: Phase 2
Study type: Interventional

Head and neck cancers(HNC) is one of the most common cancers worldwide. Xerostomia is one of the most common side effect of radiation therapy among patients with HNC. Mouth dryness significantly impairs patients' quality of life (QOL). HNC.Regarding to traditional use of A. digitata and M. sylvestris in addition to known their beneficial effects in recent studies, we decided to design a randomized, controlled clinical trial to try to evaluate efficacy of the these herbs in QOL of HNC patients with radiation induced xerostomia

NCT ID: NCT02848664 Completed - Stroke Clinical Trials

Use of the Passy Muir Swallowing Self Trainer

Start date: August 2013
Phase:
Study type: Observational

The purpose of this study is to develop appropriate training methods and gather participant feedback on their use of the Passy Muir Swallowing Self-Training Device (PMSST). The PMSST is a small device that provides external vibratory stimulation to the larynx during swallowing and swallowing training. A secondary purpose of the study is to determine how 3 months of use of the PMSST affects swallowing physiology, brain activation, oral intake and quality of life. This was an uncontrolled pilot study aimed at gaining patient feedback on use of the vibratory device.

NCT ID: NCT02842125 Terminated - Clinical trials for Recurrent Head and Neck Cancer

Safety and Efficacy of Intra-Arterial and Intra-Tumoral Ad-p53 With Capecitabine (Xeloda) or Anti-PD-1 in Liver Metastases of Solid Tumors and Recurrent Head and Neck Squamous Cell Cancer

Start date: November 20, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1/2 study of the combination of Ad-p53 administered intra-arterially in combination with oral metronomic capecitabine or pembrolizumab in patients with unresectable, refractory liver metastases of colorectal carcinoma (CRC) and other solid tumors, including primary hepatocellular carcinoma (HCC). A third arm will study the intra-tumoral injection of Ad-p53 combined with nivolumab infusions in recurrent head and neck squamous cell cancer (HNSCC). This safety study has a standard 3+3 design for arms A and B; .HNSCC will be placed in a single dosing cohort. The Maximum Tolerated Dose (MTD) will be determined as well for intra-arterial infusions, and the entire study will determine the general efficacy using RECIST 1.1 and Immune-Related Response Criteria. Safety will be followed using the CTCAE listings for adverse events.

NCT ID: NCT02841748 Active, not recruiting - Clinical trials for Head and Neck Cancer

A Randomized, Double-Blind Phase II Study of Adjuvant Pembrolizumab Versus Placebo in Head and Neck Cancers at High Risk for Recurrence- the PATHWay Study

Start date: May 10, 2017
Phase: Phase 2
Study type: Interventional

A placebo-controlled, randomized study using adjuvant pembrolizumab treatment for one year in order to potentially improve progression free survival in a squamous cell carcinoma of the head and neck cohort at high-risk for recurrence.

NCT ID: NCT02840071 Not yet recruiting - Depression Clinical Trials

ACT for Distress in Head and Neck Cancer Patients

Start date: October 2016
Phase: N/A
Study type: Interventional

Title: Acceptance and Commitment therapy for Individuals with Head and Neck Cancer Experiencing Psychological Distress. Head and neck cancer (HNC) patients are particularly vulnerable to experiencing psychological distress . The current guidelines from the National Institute of Health and Care Excellence are that cognitive-behavioural therapy (CBT) is to be offered to adults with a long-term physical health condition experiencing anxiety and depression. CBT has been shown to have several inadequacies for individuals with physical health conditions such as cancer. Acceptance and commitment therapy (ACT) takes an alternative approach to CBT, aiming to change a person's interaction with their thoughts rather than suppress or alter thought content. Although studies indicate encouraging findings for the effectiveness of ACT for individuals with breast cancer; the HNC- transfer-ability of findings is yet untested, and there is a need to evaluate the replicability of ACT effects in people living with HNC, given the unique challenges inherent to the disease and its treatment. This study aims to inform clinical practise by using a hermeneutic single-case efficacy design (HSCED) to answer the following questions: 1. Is there evidence of psychological change after the introduction of the ACT intervention? 2. If present, are the changes attributable to (a) ACT components, (b) common factors, and/or (c) non-therapeutic factors? The study will involve recruiting three adults with HNC from specialist HNC psychology services. Each participant will have six individual sessions of ACT and complete various process and outcome questionnaires during sessions. Following the intervention, participants will have a semi-structured interview where their views of the therapy and any changes made will be explored. Two outcome measures will be posted to participants at 1-month and 3-month post intervention.

NCT ID: NCT02837679 Active, not recruiting - Quality of Life Clinical Trials

Oncogeriatric Intervention and Follow-up at Home

Start date: January 2016
Phase: N/A
Study type: Interventional

The study is a randomized study of patients living in four municipalities in Eastern Jutland. After geriatric assessment half of the patients will be offered a tailor-made intervention in their homes. The follow-up will last for at least 90 days and include treatment of the patients' multimorbidity, e.g. of dehydration, anaemia, infections, and malnutrition. The other half of the patients, the results of the assessment and recommendations will be given to the patients and their general practitioner. The primary efficacy variables are accomplishment of planned cancer treatment, reduction of complications and admissions to hospital and increased quality of life,. If geriatric assessment and a tailor-made follow-up result in a better quality of life with less complications and admissions the offer may be extended to a longer period, younger age groups and other cancer diagnoses.

NCT ID: NCT02836769 Completed - Clinical trials for Head and Neck Neoplasms

Development and Evaluation of Rehabilitation Consult for Survivors of Head and Neck Cancer

HNC-RC
Start date: January 2016
Phase: N/A
Study type: Interventional

Although evidence exists to support cancer rehabilitation, services are fragmented and rehabilitation professionals are consulted infrequently and often long after treatment ends, when chronicity of problems limits the impact of intervention. Therefore, the objective of this project is to develop, implement, and conduct a pilot evaluation of the Rehabilitation Consult (RC). The RC program goals are to increase knowledge about rehabilitation needs and resources to meet those needs; to establish individualized rehabilitation goals for HNC survivors and personalized action plans to meet those goals; and to provide support to HNC survivors for the implementation and evaluation of action plans. This project consisted of intervention development and pilot evaluation; this trial registration describes the pilot evaluation phase only.

NCT ID: NCT02832102 Recruiting - Clinical trials for Cancer of Head and Neck

Big Data and Models for Personalized Head and Neck Cancer Decision Support (BD2Decide)

BD2Decide
Start date: April 2016
Phase: N/A
Study type: Observational

The purpose of this study is to determine new multiscale signatures for the prediction of head and neck cancer (HNC) patients disease outcome, in particular for advanced stage (stage III, IV) human papillomavirus (HPV) negative patients and to validate prognostic models for overall survival.

NCT ID: NCT02817113 Terminated - Clinical trials for Head and Neck Neoplasms

Study of NC-6004 in Combination With 5-FU and Cetuximab in Patients With Head and Neck Cancer

Start date: June 2016
Phase: Phase 1
Study type: Interventional

NC-6004 is a polymeric micelle containing cisplatin as an active moiety. The nanoparticle provides sustained release of the active moiety and utilizes the enhanced permeability and retention (EPR) effect to target release of platinum to tumors. This Phase I study aims to establish a recommended dose (RD) for the triplet combination of NC-6004 plus 5-FU and cetuximab as first-line treatment in patient with recurrent and/or metastatic squamous cell carcinoma of the head and neck for further clinical study development.

NCT ID: NCT02812524 Active, not recruiting - Clinical trials for Squamous Cell Carcinoma of the Head and Neck

Ipilimumab for Head and Neck Cancer Patients

Start date: November 18, 2016
Phase: Phase 1
Study type: Interventional

This study is for patients with squamous cell carcinoma of the head and neck (SCCHN). This study will test the feasibility of the administration of intratumoral injections of ipilimumab prior to surgical resection, and the immune system response to treatment.