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Head and Neck Neoplasms clinical trials

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NCT ID: NCT06285591 Recruiting - Clinical trials for Oral Mucositis (Ulcerative) Due to Radiation

Lactobacillus Reuteri Alleviates Oral Mucositis in Patients Undergoing Radiotherapy for Malignant Head and Neck Tumors

Start date: November 10, 2023
Phase: N/A
Study type: Interventional

Radiation therapy is a common treatment modality in the management of head and neck malignancies. However, head and neck tumors often have some adverse reactions when receiving radiation therapy, such as dry mouth, change of taste, oral mucositis, etc. Among them, the incidence of oral mucositis is more than 90%, and the incidence of oral mucositis of degree 3 or more than degree 3 is more than 50%. Severe oral mucositis seriously affects the quality of survival of patients. Lactobacillus Reuteri is a natural flora of the human body that can be found in the gastrointestinal tract, skin, etc. Among them, Lactobacillus Reuteri DSM 17938 and ATCC PTA 5289 can be isolated from healthy mammals as well as poultry, and are common Lactobacillus strains marketed for the production of oral probiotics, which are commonly used in infant formulas, among others. In oral inflammatory diseases, it has been reported in the literature that Lactobacillus Reuteri DSM 17938 and ATCC PTA 5289 can reduce gingival and periodontal inflammation, mainly through the mechanisms of modulating the host inflammatory response and displacing pathogenic bacteria. In terms of safety, oral Lactobacillus Reuteri has good stability, very low pathogenic potential, and is not toxic to humans. Therefore, this study is a placebo-controlled, multi-center, open, randomized controlled clinical study to evaluate the efficacy of Lactobacillus Reuteri for the prevention of radioactive oral mucosal reactions in intensity-modulated radiotherapy for head and neck tumors, including nasopharyngeal carcinoma.

NCT ID: NCT06274905 Completed - Clinical trials for Head and Neck Cancer

Topical Anaesthesia in Cutaneous Head and Neck Surgery

Start date: February 20, 2023
Phase: N/A
Study type: Interventional

This study aims to assess if EMLA or ethyl chloride spray are effective in reducing the pain associated with local anaesthetic administration in cutaneous surgery of the head and neck compared to a placebo and control group through a randomized control trial study design.

NCT ID: NCT06272617 Recruiting - Clinical trials for Radiotherapy; Complications

Acupuncture for Prevention and Treatment of Oral-related Complications Caused by Radiotherapy for Head and Neck Cancer

Start date: July 25, 2023
Phase: N/A
Study type: Interventional

A study on the efficacy and safety of acupuncture for the prevention and treatment of oral-related complications caused by radiotherapy for head and neck malignant tumors

NCT ID: NCT06272513 Not yet recruiting - Clinical trials for Advanced Head and Neck Squamous Cell Carcinoma

Influencing Factors for Physical Activity in People With Head and Neck Cancer

ProAct-HNC
Start date: March 2024
Phase:
Study type: Observational

The goal of this qualitative study is to explore influencing factors for physical activity participation in people affected by an advanced head and neck cancer from the perspective of people affected and their significant others. Individual interviews will be conducted with people affected by head and neck cancer and focus group interviews will be held with significant others of people being affected to answer the following research questions: - What capabilities and opportunities for physical activity participation do people with advanced head and neck cancer experience? - What motivates people with advanced head and neck cancer to be physically active? - How do significant others view capabilities, opportunities, and motivation for physical activity participation in people with head and neck cancer? The interviews will be transcribed verbatim and analysed with a structuring content analysis approach.

NCT ID: NCT06257121 Not yet recruiting - Anxiety Clinical Trials

Comparing Radiotherapy Immobilization Systems for Anxious HNC Patients

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

Background: Radiotherapy is a mainstay of treatment for ENT cancers, and its indication is frequent. Patients are positioned and immobilized using a thermoplastic mask, which is attached to the treatment table for the duration of each daily treatment. The mask's purpose is to prevent patient movement and ensure reproducible positioning. The advantages of using thermoplastic masks come at a cost for many patients. It is well established that mask fixation and mask anxiety are major concerns for patients, adversely affecting their quality of life and hindering treatment compliance. Surface-guided radiotherapy (SGRT) enables patients to be positioned and their movements monitored in real time during treatment. This technique has become more widely available in recent years, and is attractive because it does not involve ionizing radiation. However, although preliminary data have suggested a potential reduction in anxiety, this technique has not been evaluated for ENT RT in anxious/claustrophobic patients who cannot tolerate immobilization masks. Objective: Investigators propose a pilot study to evaluate the feasibility and tolerability of using SGRT to manage position for patients with ENT cancer who report claustrophobia/anxiety. Methodology: 15 participants will be recruited by the treating radiation oncologist from among patients scheduled to undergo radiation therapy at CHUM for their ENT cancer and identifying as claustrophobic/anxious. Participants who consent will be scheduled to undergo their radiotherapy using SGRT. Patients will be systematically treated with Volumetric Modulated Arc Therapy (VMAT) using SGRT on the linear accelerator with the Optical Surface Management System (OSMS) for the duration of the radiotherapy. Measures: Patients' anxiety will be assessed using the GAD-7 and the CLQ throughout the treatment process. The feasibility and accuracy of radiotherapy treatment will be assessed using planning and daily pre-treatment examinations. In addition, skin toxicity will be assessed weekly. Analyses: 1) Descriptive analyses, i.e. frequencies for categorical variables and means and standard deviations for continuous variables. 2) Estimation of confidence intervals. Anticipated outcomes: Completion of this pilot project will enable investigators to plan and refine the methodological and organizational aspects for a large-scale study, i.e., a Phase III clinical trial comparing the use of SGRT with the use of a thermoplastic immobilization mask for anxious patients.

NCT ID: NCT06256588 Not yet recruiting - Clinical trials for Neoplasms, Head and Neck

A Study of Dostarlimab vs Placebo After Chemoradiation in Adult Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma

JADE
Start date: March 4, 2024
Phase: Phase 3
Study type: Interventional

The goal of this study is to assess the safety and effectiveness of Dostarlimab compared to Placebo in adult participants with HNSCC (Head and Neck Squamous Cell Carcinoma)

NCT ID: NCT06251050 Not yet recruiting - Clinical trials for Head and Neck Squamous Cell Carcinoma

A Lithium-containing Mouthwash Prevention and Treatment of Oral Mucositis and Dysgeusia in Patients Undergoing Radiotherapy

Start date: March 1, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

To evaluate the efficacy and safety of lithium-containing mouthwash for prevention and treatment of oral mucositis and dysgeusia in patients undergoing radiotherapy for malignant head and neck tumors.

NCT ID: NCT06248996 Recruiting - Clinical trials for Head and Neck Squamous Cell Carcinoma

a Multicentre Phase III Study of Risk-based Treatment Intensification With Hyperfractionated Radiotherapy in Head and Neck Cancer Patients

ARTSCAN VI
Start date: March 4, 2024
Phase: Phase 3
Study type: Interventional

There is an unmet need to personalise treatment for patients with head and neck squamous cell carcinoma (HNSCC) and to improve treatment results for patients with advanced disease. In this phase III study, HNSCC patients with prognostic factors indicating increased risk of treatment failure that are aimed for curative treatment with radiotherapy (RT) will be randomised between standard treatment (conventionally fractionated RT with final RT dose 68.0 Gy) and hyperfractionated RT (HFX-RT) with final RT dose 83.0 Gy. In order to find better prognostic and predictive tools the study also includes exploratory and translational analyses including evaluation of grade of hypoxia with Magnetic Resonance Imaging (MRI) and gene profiling by RNA-sequencing, tumour immune profiling, comparisons of global gene expression, gene aberrations and protein expression, and texture analyses of CT, FDG-PET and MRI images used during RT preparation and during patient follow-up. Patients with tumours with lower risk of recurrence, not eligible for randomisation in the study, can still participate in the translational parts of the study not investigating response to altered fractionation.

NCT ID: NCT06240689 Recruiting - Clinical trials for Locally Advanced Head and Neck Squamous Cell Carcinoma

A Prospective Randomized Controlled Study of Immune Checkpoint Maintenance Therapy After Radiotherapy and Chemotherapy for Locally Advanced Head and Neck Tumors Based on Peripheral Blood CD8Tex Detection in Peripheral Blood

Start date: January 25, 2024
Phase: Phase 2
Study type: Interventional

The goal of this prospective, randomized, single-blind controlled clinical study is to explore the efficacy of maintenance therapy with Sintilimab after chemoradiotherapy in locally advanced head and neck squamous cell carcinoma. The main questions it aims to answer are: How works well the Sintilimab was in the treatment group? How safe the Sintilimab is? Participants will intravenous Sintilimab or placebo (a look-alike substance that contains no active drug) within 1 month after the end of chemoradiotherapy, and 21 days is a cycle. Blood tests, electrocardiogram are rechecked every 2 cycles, and CT was rechecked every 4 cycles to evaluate toxicity and side effects and recurrence. Researchers will compare invention group to control group to see if the Sintilimab works well.

NCT ID: NCT06239220 Recruiting - Clinical trials for Head and Neck Cancer

PD-L1 t-haNK, N-803 IL-15sa and Cetuximab for Recurrent, Metastatic HNSCC

Start date: February 16, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this research study is to test the safety and efficacy of the combination of PD-L1 t-haNK (modified immune cells), N-803 (a manufactured protein that stimulates the immune system), and cetuximab (a targeted antibody) in treating advanced head and neck cancer. The names of the therapies involved in this study are: - PD-L1 t-haNK cell therapy (a NK cell therapy infusion) - N-803 (a type of recombinant human superagonist) - Cetuximab (a type of antibody)