Active clinical trials for "Head and Neck Neoplasms"

Patients with human papillomavirus (HPV)-related oropharyngeal cancer generally have favorable outcomes and how well they do depends on the specific details about the patient and their cancer. How well they do isn't as related to the kinds of treatment they get. However, there are significant side effects for the various types of treatments they may get. Because these patients generally have favorable outcomes no matter the kind of treatment, reducing side effects should be a priority when choosing their treatment. The goal of this clinical research study is to evaluate whether a new blood test called a Circulating Tumor DNA test (ctDNA test) can decrease the number of people that require radiation after surgery. This blood test is often elevated in people when they are diagnosed with head and neck cancer. There are studies that show that cancer most often returns when this blood test is positive after treatment. This study will test patients' blood before and after surgery. In cases where the test is negative after surgery, people on the study will not receive radiation unless they are considered high risk based on surgery findings. The hope is that radiation and its potential side effects can be limited to only people that need the treatment.

Patients with cancer have increased risk of malnutrition due to the disease itself and the treatment regimen they undergo. This is particularly relevant for patients with head and neck cancer (HNC), where 74%-95% are malnourished. HNC is a heterogenous group of cancers, including oral cavity, larynx, pharynx and salivary glands. The present project will study the effectiveness and implementation of remote patient monitoring of nutrition and tailored nutrition support throughout the treatment course in patients with head and neck cancer. The implementation will be evaluated in a randomized controlled trial (RCT), and the aim of the project is to reduce the prevalence of malnutrition and increase the quality of life among patients with HNC.

Approximately 60% and 90% of patients with head and neck (H&N) cancers receiving standard radiotherapy (RT) and chemoradiotherapy (chemo-RT) will develop oral mucositis respectively. Oral mucositis (OM) is one of the dose-limiting adverse events which can also lead to emotional and nutritional problems. Clinically, it is usually observed by the end of first week of RT (after 10 Gy) and reaches peak damage in 14-21 days or by the end of treatment. Healing then takes approximately 2 to 3 weeks after completion of RT. For the Chinese Medicine (CM) interventions, many studies have been reviewed on the efficacy of mouthwash or internal herbal decoction to OM. Although some positive results were observed, most of them were performed by applying different assessment tools and lack of quality of life (QOL) or self-reported symptoms assessment. In addition, the intervention time and follow-up period were usually insufficient (stopped at the end of RT), therefore they could not review the long-term efficacy of CM according to normal progression of OM and the safety of using CM. Therefore, we hope this pilot study can evaluate the efficacy and safety of CM in a strict protocol.

The overarching goal of the NAVIGATORR trial is the improvement of local tumor control in head-and-neck cancer (HNC) by increasing the precision of surgical resection and individualization of radiotherapy. Squamous cell carcinomas (SCC) together with salivary gland carcinomas (adenoid cysytic Carcinoma (ACC), mucoepidermoid Carcinoma (MEC), adenocarcinoma (AC)) represent the most common entities in German head and neck oncology. In localized tumors, primary tumor resection with possible adjuvant (chemo)radiotherapy is still the treatment of choice. Advances in targeted therapy and immunotherapy have greatly expanded the repertoire of medical oncology in recent years. In particular, prognosis of patients with end-stage non-small cell lung cancer (NSCLC) has been improved and even patients with advanced head and neck disease can be offered new second line regimes. Importantly, all of these advances are based on personalized and targeted therapies. Unfortunately, surgical oncology in the head-and-neck region has not yet shown such developments towards individualized treatment, so that the rates of safe oncological resections (clear resection margins) haven been stagnating. Despite advances in reconstructive surgery that allow the resection of head-and-neck tumors that would not have been operable 10 - 15 years ago, the basic principles of the resection margin and especially margin evaluation have remained unchanged. The technique of navigation-based tumor resection and the annotation of biopsies by titanium clip-markings or special annotation have been described, but only in small case series and without proving the benefit of the method concerning clinically relevant parameters. Therefore, the NAVIGATORR trial will enroll 60 patients with HNC of the midface that will undergo navigation-based surgery. Importantly, interdisciplinary data exchange of the intraoperative navigation data between surgeons, pathologists and radiation oncologists will be established. Clear surgical margins (distance between tumor cells and resection border > 5 mm) have been defined as primary endpoint. Secondary endpoints such as dosimetric assessment of individualized radiotherapy plans, local tumor control or overall survival should then be compared to data from the literature to further assess this multidisciplinary approach.

This is a phase 1b study in adult patients diagnosed with resistant or recurrent head and neck squamous cell carcinoma (HNSCC) designed to assess the safety and tolerability of IK-175 in combination with nivolumab. Disease response, pharmacokinetics (PK), pharmacodynamics, and response biomarkers will also be assessed.

Head and Neck invasive cancer usually requires surgery that is associated with modifications of the body structure of patient regarding breathing, eating and communication. These modifications are correlated with an important loss of autonomy in patients. During the study, while the patient is hospitalised after the surgery, the paramedical team will train the caregiver of the patient from experimental group a new dimension of autonomy in order to assure a safe return home. The level of learning depends on each caregiver and patient; therefore, an adapted training is provided. This study evaluates the impact of paramedical care in accompanying caregivers of patients that had surgery for an ENT invasive cancer, by comparing the experimental group (paramedical care) to the standard group (standard care). The hypothesis of the study is that a benefit will be seen in the experimental group, by reducing the caregiver burden, improving the quality of life of patients and lowering the rate of hospitalisations and prolonged hospitalisations in these patients.

The purpose of this study is to explore the efficiency and safety of anti-Programmed death-1 (PD-1) immunotherapy, tislelizumab, combined with EGFR-tyrosine kinase inhibitor (TKI), afatinib as a new neoadjuvant treatment regimen for patients with resectable head and neck squamous cell carcinoma (HNSCC).

In this multi-center randomized clinical trial, head and neck cancer (HNC) survivors with clinically significant body image distress (BID) (N=180) will be randomized to BRIGHT (a brief video tele-cognitive behavioral therapy intervention) or Attention Control (AC, a manualized tele-supportive care intervention that controls for professional attention, dose, delivery method, and common factors). HNC survivors will complete IMAGE-HN (a validated patient-reported outcome measure [PROM] of HNC-related body image distress [BID]; primary endpoint), measures of psychological and social well-being and quality of life (QOL), and measures of theory-derived mechanisms of change underlying BRIGHT (mediators).

The purpose of the study is to design a physical activity and dietary intervention for head and neck cancer patients.

The primary and general objective of the clinical introduction of the SFP as the current standard of care is to improve the quality of radiotherapy for head and neck cancer patients by reducing radiation-induced side effects without hampering treatment efficacy in terms of locoregional tumour control and overall survival and to systematically evaluate the beneficial effect of newly introduced radiation technology for this particular group of patients. The clinical introduction of the SFP will allow for a systematic and broad scale quality improvement cycle for head and neck cancer patients treated with radiotherapy. In fact, this methodology can be considered a kind of quality circle for the clinical introduction of new radiation techniques, aiming at continuous efforts for further improvement.