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Head and Neck Neoplasms clinical trials

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NCT ID: NCT06398899 Not yet recruiting - Clinical trials for Head and Neck Neoplasms

Sugammadex v.s. Neostigmine/Glycopyrrolate

Start date: May 1, 2024
Phase: N/A
Study type: Interventional

The aim of study is to clarify the role of sugammadex in head and neck surgery patients with a prior history of urinary retention, benign prostatic hypertrophy, or a history of prostate cancer, to prevent postoperative urinary retention. The main question it aims to answer are: - Anticholinergic agent interferes the postoperative urination - Sugammadex does not interfere postoperative urination Sugammadex can be recommended for these patients with high risk in postoperative urinary retention in the future.

NCT ID: NCT06385587 Not yet recruiting - Clinical trials for Head and Neck Cancer

Technology-based Symptom Monitoring Intervention for Locally Advanced Head and Neck Cancer Patients

SYMTECH01
Start date: May 3, 2024
Phase:
Study type: Observational

The goal of this observational study is to assess the satisfaction and usability of an interactive and patient-centered mobile application (app), Oleenaâ„¢, designed to assist head and neck cancer patients undergoing chemoradiation in managing common and distressing symptoms in real-time, as well as to assess the satisfaction and usability of the related HCP web portal. Additional secondary usage and clinical endpoints that would be used to assess intervention efficacy in future trials will be collected.

NCT ID: NCT06385132 Not yet recruiting - Clinical trials for Head and Neck Cancer

Psychological and Psychiatric prOfile in Glioblastoma and Head and Neck Cancer

APPOINT
Start date: April 15, 2024
Phase:
Study type: Observational

Approximately 30% of cancer patients may experience psychopathological disorders. The most common psychopathological disorders in cancer patients are mood disorders, anxiety, depression, adjustment disorders, and suicidal ideation. Among depressive disorders, mixed depression, with the simultaneous presence of symptoms of both depressive and manic polarity, is associated to higher levels of chronicity, functional impairment and suicidality. These disorders can also be worsened by loneliness and demoralization. Patients with head and neck cancer (H&N-C) and Glioblastoma multiforme (GBM) have high psychological and sometimes psychiatric comorbidity probably due to the severity, poor prognosis of these cancers and harsh treatment toxicities. The most important protective factor for psychopathology is psychological resilience, which is "the capacity of a person to protect themselves and their mental health when facing life adversities," such as a GBM or H&N-C diagnosis. Resilience is influenced by the affective temperament, which refers to basic personality traits related to behavioral and emotional reactivity to environmental stimuli. It is believed to be biologically determined and relatively stable throughout life. To date, the literature does not clarify the role of resilience and temperament in mediating the psychological profile of cancer patients. Furthermore, extensive profiling of the psychological and psychiatric profile of these patients at such a critical and pivotal moment in their journey is currently lacking in the literature. Aim of this study is to evaluate global psychological and psychiatric profile of patients affected by GBM and H&N-C and the eventual fluctuation over time during RT course. Conducting an early and accurate screening for potential psychopathological issues will give the opportunity to avoid factors that could: worsen patient compliance, lead to suicidal risk, and increase hospitalizations. The results obtained will be utilized for planning precocious psychological or psychiatric take-in-charge aimed at promoting psychological well-being of H&N-C and GBM patients.

NCT ID: NCT06367257 Not yet recruiting - Clinical trials for Squamous Cell Carcinoma of Head and Neck

App-based Recording and Optimization of the Nutritional Status in Patients With Head and Neck Tumors During and After Radio(Chemo)Therapy

Start date: May 1, 2024
Phase: N/A
Study type: Interventional

Patients with head and neck cancer requiring definitive or adjuvant radio(chemo)therapy can take part in the study. The aim is to record the nutritional status and diet of the patients during the trial and regularly at a period of 8 weeks after irradiation and to reduce the rate of weight loss and malnutrition.

NCT ID: NCT06366945 Not yet recruiting - Clinical trials for Head and Neck Cancer

Tirelizumab in Combination With Carboplatin and Polymeric Micellar Paclitaxel for Neoadjuvant Therapy in cN+ HNSCC

Start date: April 20, 2024
Phase: Phase 2
Study type: Interventional

To explore the efficiency and safety of Tislelizumab combinated with carboplatin and polymeric micellar paclitaxel as a new neoadjuvant treatment regimen for resectable HNSCC patients with clinical positive lymph node metastasis

NCT ID: NCT06360978 Not yet recruiting - Clinical trials for Head and Neck Cancer

Efficacy and Toxicity of Docetaxel as a Radiosenstizer in Head and Neck Cancer

Start date: April 2024
Phase: Phase 2
Study type: Interventional

Head and neck cancer (HNC) is the seventh most common cancer globally, accounting for more than 660,000 new cases and 325,000 deaths annually. The overall incidence of HNC continues to rise, with a predicted 30% increase annually by 2030., this increase has been recorded across both developed and developing countries. Approximately 90% of HNCs are squamous cell carcinoma . The major risk factors of head and neck squamous cell carcinoma (HNSCC) are tobacco and heavy alcohol use and human papillomavirus infection . There has been a significant decline in smoking in high-income countries during the last few decades, which has led to a sharp decline in smoking related HNSCC . While increase in global incidence of human papillomavirus (HPV)-associated or positive (+) HNSCC Head and neck squamous cell carcinoma (HNSCC) is a highly challenging cancer, despite the advancements in treatment, the overall prognosis for HNSCC remains poor, with a five-year survival rate of around 50%. Chemoradiation is one of the treatment options for locally advanced head and neck cancers, the drug of choice for radiosensitization is cisplatin Although cisplatin-based chemoradiotherapy (CRT) is the standard of care for locally advanced head and neck squamous cell carcinoma (LAHNSCC), cisplatin is contraindicated in many patients because of age, diminished renal functions and hearing loss so docetaxel studied as an alternative radiosensitizer in this group. The addition of docetaxel to radiation improved DFS and OS in cisplatin-ineligible patients with LAHNSCC.

NCT ID: NCT06358053 Not yet recruiting - Cervical Cancer Clinical Trials

CRTE7A2-01 TCR-T Cells for HPV-16 Positive Advanced Cancers

Start date: April 15, 2024
Phase: Phase 1
Study type: Interventional

A single center, open, single arm dose escalation and dose expansion phase I study to evaluate the safety, tolerability, and efficacy of CRTE7A2-01 TCR-T cells in HLA-A*02:01+ Subjects HPV16 positive advanced cervical, anal, or head and neck cancers. The study will determine RP2D of CRTE7A2-01 TCR-T cell injection.

NCT ID: NCT06353685 Not yet recruiting - Clinical trials for De-escalated Radiotherapy; Head and Neck Cancer

De-Escalation Postoperative Radiotherapy for Oral Squamous Cell Carcinoma With pCR/MPR.

Start date: May 1, 2024
Phase: Phase 2
Study type: Interventional

The prognosis of locally advanced oral squamous cell carcinoma(OSCC ) is poor, and there are still many problems to be solved in the current treatment paradigm. Neoadjuvant chemotherapy combined with immunotherapy can significantly improve the pCR and MPR rates in patients with locally advanced OSCC. For patients who achieve pCR and MPR after neoadjuvant therapy and surgery, it is still hotly debated regarding whether to implement postoperative de-escalation radiotherapy. Neoadjuvant therapy is an ideal predictor of radiosensitivity. In theory, neoadjuvant therapy can eliminate microscopic lesions, thereby reducing the dose and volume of irradiation. Continuous hyperfractionated accelerated radiotherapy (CHART, based on hyperfractionated radiotherapy, increasing daily or weekly treatments and shortening the total treatment duration, but reducing the total dose), is to give a higher dose of radiation to tumor tissue in a shorter period of time, so as to overcome the accelerated reproliferation and inhibit the repair of sublethal damage of tumor cells. It is beneficial to improve the local control rate of tumor, control the acute injury of normal tissue and the yield acceptable late treatment-related complications. The specific protocol was as follows: high-risk CTV area (CTV1), 45Gy in total, fraction dose of 1.5Gy, twice a day, bioequivalent dose (BED) of 51.75Gy; Low-risk CTV area(CTV2), 39Gy in total , fraction dose of 1.3Gy, twice a day, BED of 44.07Gy; A total of 30 radiotherapy fraction were performed 10 times a week for 3 weeks.

NCT ID: NCT06347185 Not yet recruiting - Clinical trials for Head and Neck Neoplasms

Simultaneous Care in Recurrent and/or Metastatic Head and Neck Cancer: the SupCare Study

SupCare
Start date: September 2024
Phase: N/A
Study type: Interventional

This is a late phase II, prospective, multicenter randomized study, to assess the value of early palliative care integrated with the standard oncologic care in patients with Recurrent Metastatic (RM) Head and Neck Cancer (HNC) proposed to first line palliative systemic treatment. The study randomizes patients in a 1:1 fashion to standard oncologic care, in which the palliative care is requested as needed (reactive approach) or to early palliative care integrated with the standard oncologic care (proactive approach). Standard of Care: the oncologist will be the main referral of the patient, deciding the therapeutic approach, the assessments requested, in terms of type of exams and timing and the need of possible further support from other expertise. The oncologist will base the choices also upon the results of the Liverpool Head and Neck Patient Concern Inventory (PCI-H&N) and the patient's preferences. At the end of the first oncological visit, the physician will be asked to predict the survival of the patient. Integrated approach: Besides the Oncology visit, patient will have the palliative care expert visit and follow up. The oncologist will define the therapeutic approach and the assessments requested, in terms of type of exams and timing. The palliative care clinician and the oncologist will judge the burden of symptoms and together they will propose the suggested interventions to relief the symptoms, with a particular attention to a validated instrument (the PCI-H&N) and patient priority questionnaire's results. Stratification Factors - Institution - Performance Status (PS) (0 vs 1-2) - Presence of any caregiver at home - Type of treatment (Immunotherapy alone vs any other combination) Study duration: the total study duration is estimated at 36 months, with a total accrual time estimated to be 24 months from first patient in (FPI) and with an additional follow-up period of 12 months. End of study occurs when all patients have completed their end of study visit and the study is mature for all analyses defined in the protocol and the database has been cleaned and frozen for these analyses.

NCT ID: NCT06307418 Not yet recruiting - Clinical trials for Head and Neck Cancer

Internet-based Support for Informal Caregivers of Patients With Head and Neck Cancer - Carer eSupport

Start date: May 6, 2024
Phase: N/A
Study type: Interventional

The aim of this randomized controlled trial is to investigate the effects of internet-based support (Carer eSupport) on preparedness for caregiving in informal caregivers of patients with head and neck cancer. The main question[s] it aims to answer are: - What are the effects of internet-based support on informal caregivers preparedness for caregiving? - What are the effects of internet-based support on informal caregivers burden and wellbeing? Informal caregivers who are randomized to Carer eSupport will have access to Carer eSupport for 18 weeks and they will be asked to complete questionnaires (outcome measures) at: - baseline (before randomization) - 18 weeks (post-intervention) and at - 3 months after the intervention is completed (long term follow-up). Informal caregivers in the intervention group will be compared to informal caregivers who receive standard care support regarding preparedness for caregiving, caregiver burden and wellbeing.