View clinical trials related to Head and Neck Neoplasms.
Filter by:Head and neck cancers that occurred during pregnancy
This phase I trial studies the side effects of interstitial photodynamic therapy (I-PDT) in treating patients with head and neck cancer that has spread to other parts of the body or that has come back. Interstitial photodynamic therapy uses a light-sensitive drug called porfimer sodium. This drug is activated by laser light delivered through special fibers into the tumor. In this study the doctors will evaluate the safety of I-PDT and determine the potentially effective light setting in this treatment.
Objectives: This is a feasibility study in preparation for the main multicentre randomised trial, which is anticipated to have two arms: - Arm A: the current best standard of care [rehabilitation exercises] - Arm B: the current best standard of care [rehabilitation exercises] + the experimental intervention In this feasibility trial the following aspects will be evaluated: - Recruitment rates [that is also willingness to be randomised] - Feasibility of providing the experimental intervention at the NHS study sites - Retention rate/drop out rate - Feasibility and acceptability of (i) proposed primary outcome [patient-centred], (ii) a range of additional patient-centred and clinician-centred outcomes - Standard deviation of the proposed primary outcome so to inform sample size calculation of the main trial. - Safety/toxicity of the study medication. Type of trial: Multicentre, parallel group, randomised controlled trial in 50 patients with radiotherapy-induced fibrosis of the head and neck. Trial design and methods: Participants over the age of 18, with radiotherapy-induced fibrosis of the head and neck will be given information about the trial and invited to participate. 50 participants who consent will be recruited and randomised to either: - Treatment with pentoxifylline 400 mg tablets twice a day [total 800mg/day] + 500IU tocopherol acetate solution twice a day [total 1000 IU/day] in addition to best standard care [a structured programme of rehabilitation exercises] for 6 months or - Best standard of care [a structured programme of rehabilitation exercises] for 6 months. Randomisation will be carried out online Trial duration per subject: 6 months Estimated total trial duration: 56 months Planned trial sites: Multi-site Total number of subjects planned: 50 participants Main inclusion/exclusion criteria: Inclusion Criteria: - Subjects aged ≥18 years - Previous history of Head & Neck Cancer - Previous radiotherapy to the Head & Neck - minimum 50 Gy completed at least 12 months before screening visit - Cancer-free for a minimum of 12 months after completion of radiotherapy. - Diagnosis of radiotherapy-induced fibrosis of the head and neck: trismus and/or dysphagia Exclusion Criteria: - History of primary cancer resection and/or reconstructive surgery to anatomical areas involved in swallowing and/or chewing. - Concomitant presence of other disorders that may cause pharyngeal/oral fibrosis - Known hypersensitivity to pentoxifylline or tocopherol (vitamin E). - History of acute porphyrias or haemorrhagic disorders - Active/ongoing hypotension - Diabetes - Pregnancy - Subjects with osteoradionecrosis - Breastfeeding mothers - Subjects with a MIO <12mm Statistical methodology and analysis: Analysis of this feasibility trial will be mainly descriptive, measuring recruitment rate, acceptance of randomisation, attrition from treatment and trial, and completion rates for the outcome measures (to gauge acceptability and appropriateness).
Background Post-radiotherapy head and neck cancer (HANC) patients are at increased risk of dental caries and periodontal disease due to radiation-related damage to the teeth and salivary glands. Currently the exact aetiology of post-radiotherapy dental disease, and variation in its incidence and severity based on tumour location and radiotherapy dose, is poorly understood. Consequently there is a lack of clear guidance on how HANC patients should be dentally managed both before and after their radiotherapy. Aim The aim of this study is to quantify the relationship between dental radiation dose, 'spared' parotid gland radiation dose, tumour location, and post-radiotherapy dental disease. Methods A prospective cohort study will be undertaken in HANC patients treated with radiotherapy. A total of 215 patients will be recruited over a period of 2.5 years. Participants will be assessed and rendered dentally fit prior to radiotherapy in the School of Dentistry, Belfast. All patients will be followed-up at 6, 12, and 24-months post-radiotherapy. Data to be collected at each visit will include: total number of carious teeth, periodontal disease indices, salivary flow rates, diet, oral hygiene, mouth opening, xerostomia and oral health-related quality of life. Radiotherapy, including individual tissue-dose exposures, will be prescribed by the Clinical Oncology team as per current practice. Doses to the teeth and 'spared' parotid gland will be determined using radiotherapy research software (Non-Clinical Eclipse System sold by Varian Medical Systems UK Ltd). Using appropriate statistical tests, data analysis will determine the relationship between dental disease, radiation dose, and tumour location. Anticipated variation in the incidence and severity of post-radiotherapy dental disease based on the radiotherapy dose and tumour location, will inform the development of a clinical risk-assessment tool that will allow dentists to categorise patients as 'high' or 'low' risk of future disease. Guidelines regarding pre-radiotherapy dental extractions and post-radiotherapy preventative strategies will also be developed and will advise clinicians based on this risk assessment. A micro-costings study will be undertaken to evaluate patient and healthcare costs associated with the diagnosis and management of pre- and post-radiotherapy dental disease.
This phase I trial studies how well anti-semaphorin 4D (SEMA4D) monoclonal antibody VX15/2503 (VX15/2503) with or without ipilimumab and/or nivolumab work in treating patients with stage I-IVA head and neck squamous cell cancer. Monoclonal antibodies, such as VX15/2503, ipilimumab, and nivolumab, may interfere with the ability of tumor cells to grow and spread.
This prospective randomized controlled clinical Trial will be performed in patients with locally advanced squamous cell carcinoma of the head and neck. The objectives of the trial are to compare the efficacy and safety of Capecitabine treatment with placebo as adjuvant therapy to patients who have received radiotherapy.
This open, single-arm, exploratory study looked at the efficacy and safety of apatinib in combination with S-1 as second-line treatment of advanced head and neck malignancies.
Nivolumab is FDA-approved for the treatment of patients with recurrent/metastatic Head and Neck Squamous Cell Carcinoma (HNSCC). HNSCC whose disease has progressed within 6 months after platinum-based chemotherapy. The development of predictive biomarkers is needed to optimize patient benefit, minimize risk of toxicities and guide combination strategies.
Whatever are the strategies of coverage, the consideration of the state of bad nutrition is not often the priority. According to the last recommendations (2012) of the French Society Clinical Nutrition and Metabolism (SFNEP), the surgeries of the cancers of the VADS are not listed among surgeries with high morbidity. So the specific recommendations for the patients undernourished with surgery with low morbidity, only a personalized dietary advice and oral nutritional supplements are recommended in preoperative. There is no specific recommendation in post-operative. Two groups of cancer patients of the VADS will be compared: a control group benefiting from a nutritional coverage based on the current recommendations of the SFNEP, an experimental group benefiting from an improved nutritional coverage. In preoperative, all the patients of experimental group will benefit from dietary advice during a multidisciplinary specific consultation. In post-operative, a dietetic consultation will be set up in 7 days at the exit of hospitalization and call phone at M1, M2, M4 and M5. And for the undernourished patient will benefit a multidisciplinary consultation at the rate of a consultation a month during 6 months. In the Group control, the patients will be followed according to the current recommendations of the SFNEP.
The purpose of this study is to test the safety of a study drug called PARPi-FL. This drug has been tested in animals but not yet in people. The purpose of this study is to test if a PARPi-FL scan can be used to take pictures of head and neck cancer. The usual approach to imaging this cancer includes several different imaging scans, including x-rays, CT (computed tomography), MRI (magnetic resonance imaging), and PET (positron emission tomography). These tests take pictures of the cancer.