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Head and Neck Cancer clinical trials

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NCT ID: NCT06444776 Recruiting - Clinical trials for Head and Neck Cancer

Therapy-Associated Saliva and Taste Change Evaluation (TASTE) in Head & Neck Cancer Patients Undergoing Radiotherapy

TASTE
Start date: December 19, 2022
Phase:
Study type: Observational

One of the main side effects of radiation therapy to the head and neck region is altered taste sensation. This causes significant morbidity and has profound effects on the quality of life (QoL) of patients. While radiation-associated toxicities like xerostomia and dysphagia are part of large investigations, data on taste impairment is sparse. The TASTE study sets out to further our understanding of this common side effect with the goal to prevent radiation-associated taste impairment in future patients. In this prospective, observational multicenter study 150 head and neck cancer patients undergoing radiation therapy will be recruited. Participants will undergo repetitive (semi-) objective and subjective assessment of their taste, smell and salivary function at specific time points before, during and after radiotherapy. Primary endpoint will be patient-reported taste impairment 12 months post radiation therapy using a standardized quality of life questionnaire (MDASI-HN). Secondary endpoints will include taste impairment measured using taste strips at 12 months and 2 years post radiation therapy. Differences between subgroups (radiation side, chemotherapy, etc.) and changes over time will be assessed while adjusting for confounding factors (e.g. age, sex, smoking history). Based on the aquired data, a normal tissue complication probability model for late radiation-associated taste impairment will be develeoped.

NCT ID: NCT06345287 Recruiting - Clinical trials for Head and Neck Cancer

Response Adaptive Radiotherapy Following Immunotherapy-based Induction for Non-HPV Related HNSCC

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

The aim of this study is to develop an adaptive radiation therapy plan for locally advanced head and neck squamous cell carcinoma receiving induction therapy containing immunotherapy and chemotherapy. The therapy plan is based on clinical remission, in order to reduce treatment-related toxic side effects without sacrificing clinical efficacy and improve the quality of life of patients.

NCT ID: NCT06344208 Recruiting - Clinical trials for Head and Neck Cancer

Predicting Toxicity in Elderly Patients With Head and Neck Cancer

PREtoxEL
Start date: March 15, 2022
Phase:
Study type: Observational

Predicting toxicity in elderly patients with head and neck cancer: validating a disease-oriented toxicity predictive tool and integrating it with avail-able screening tools for better outcomes.

NCT ID: NCT06341985 Recruiting - Clinical trials for Head and Neck Cancer

DOsimetry and Radiation Induced NAusea in Head and Neck Cancers

DORIAN
Start date: November 15, 2021
Phase:
Study type: Observational

This is a prospective cohort study for the analysis of correlation between dosimetric parameters and RANV (Radiation Associated Nausea and Vomiting) in patients with head and neck cancer undergoing exclusive radiotherapy (RT). The primary purpose of this study is to search for a potential correlation between dosimetry and physician- and patient-rated symptoms in patients treated with exclusive radiotherapy for head and neck cancer.

NCT ID: NCT06327139 Recruiting - Clinical trials for Head and Neck Cancer

Optimising Patient Experience in Head and Neck Radiotherapy

OPEN
Start date: January 2, 2024
Phase: Phase 3
Study type: Interventional

This study is a phase III, randomized, single-centre, multiple arm trial examining the set-up accuracy of three different types of immobilization methods for head and neck cancer patients receiving radical radiation therapy. The methods of immobilization under investigation in this study are two types of open faced head and neck masks compared with the convention closed faced head and neck mask. Patients receiving treatment using an open faced mask will have their intra fraction motion monitored through the use of intra fraction surface guided monitoring. The study aims to determine the set-up accuracy of the three types of immobilization through measuring the magnitude of the translational corrections on the daily cone beam computed tomography (CBCT). To be eligible for the study a patient must be planned to receive a minimum of 30 fractions of head and neck radiation therapy. Patients distress levels associated with each type of immobilization device will be measured using the psychological measure General Health Questionnaire-12 (GHQ-12) which will be collected at the beginning and end of their course of radiation therapy treatment.

NCT ID: NCT06321640 Recruiting - Breast Cancer Clinical Trials

Study for the Multidimensional Analyses of Resistance and Toxicity to Immune- and Targeted-therapies.

POSITive
Start date: July 8, 2022
Phase:
Study type: Observational

Novel treatment modalities like targeted therapies and Immune checkpoint inhibitors have revolutionised the therapeutic landscape in oncology and hematology, significantly improving outcomes even in clinical contexts in which little improvement had been observed for decades such as metastatic melanoma, lung cancer, and lymphoproliferative neoplasms such as chronic lymphoid leukemia or Hodgkin lymphoma. However, major issues remain unsolved, given the frequent occurrence of primary or secondary resistance and the still incomplete understanding of the physiopathology of adverse events, which represent a major cause of morbidity and treatment interruption and often remain difficult to treat and diagnose. In this complex landscape, identifying the best treatment option for each patient remains challenging. For both targeted therapies and Immune checkpoint inhibitors, several biomarkers have been reported, but their implementation in clinical practice is still uncommon, and most of the decision-making process remains based on purely clinical considerations or constraints dictated by the regulatory bodies. Obstacles to biomarker-driven decision making are manifold and include insufficient understanding of the underlying biology, lack of strong evidence on their predictive power and limited tumor sampling, which may be circumvented by non-invasive techniques such as liquid biopsies.

NCT ID: NCT06308796 Recruiting - Clinical trials for Head and Neck Cancer

Prevention of Caries in Head and Neck Cancer Survivors Who Underwent Radiotherapy

RADIOCARIES
Start date: April 1, 2023
Phase: N/A
Study type: Interventional

One of the long-term side effects of head and neck radiotherapy (RT) is radiation-induced tooth decay. Hyposalivation, associated with radiation therapy, further increases caries susceptibility and caries progression, due to the lack of salivary protective effects and of tooth minerals useful for remineralization processes, especially calcium phosphate (CaP). Dental extractions that could be required in case of severe tooth decay expose the patient to the risk of osteoradionecrosis of the jaws (i.e. the necrosis of the bone tissue following a local trauma, including surgical trauma). This protocol aims at verifying the effectiveness of CaP mousse in the prevention of carious lesions, added to topical fluoride. A randomized controlled clinical trial will be performed comparing CaP + fluoride treatment versus no treatment in head and neck cancer patients, who received radiotherapy. The hypothesis is that CaP, which is lacking in the mouth of these patients due to hyposalivation, can combine with fluoride to promote remineralization, reducing the risk of carious lesions.

NCT ID: NCT06307327 Recruiting - Clinical trials for Head and Neck Cancer

Comparative Study of New Classification and Traditional Classification of Radioactive Oropharyngeal Mucositis

Start date: March 2024
Phase:
Study type: Observational

Radiation oropharyngeal mucositis is one of the most painful side effects of radiotherapy in patients with head and neck tumors. However, the traditional radioactive oropharyngeal mucositis grading system has the problem of poor evaluation consistency. To solve this problem, we innovatively classify radiation oropharyngeal mucositis into four types according to the four-stage histopathological changes of acute radiation injury: (1) congestive; (2) Scattered erosion type; (3) Fusion erosion type; (4) Ulcer type. We intend to conduct a multicenter observational cohort study to compare the consistency of different physicians in the assessment of radiation oropharyngeal mucositis with new and traditional classifications, and to explore changes in blood markers of different types of oropharyngeal mucositis using clinical residual blood samples.

NCT ID: NCT06307314 Recruiting - Clinical trials for Head and Neck Cancer

Plasma SAA1 Levels in Predicting Response to Radiotherapy-induced Oral Mucositis

Start date: February 1, 2024
Phase:
Study type: Observational

Head and neck squamous cell carcinoma (SCC) is the sixth most common cancer worldwide, with more than 700,000 new cases and more than 350,000 deaths each year. At present, radiotherapy is an important measure to control the recurrence of head and neck tumors, but almost all patients with head and neck squamous cell carcinoma will have acute inflammatory reactions such as radiotherapy-induced oral mucositis (RIOM) after radiotherapy, which seriously affects the quality of life and radiotherapy efficacy of patients. Serum amyloid A1 (SAA1) is an acute phase protein associated with inflammation. Our previous basic research found that serum SAA1 expression levels can be used as biomarkers to assess the dose received by the receptor in the early stages of radiation damage. At the same time, we confirmed that the serum level of SAA1 in patients with nasopharyngeal carcinoma increased after radiotherapy. Therefore, we intend to conduct a prospective, multicenter, observational study to further explore the predictive power of plasma SAA1 levels for radiotherapy-induced oral mucositis, with a view to early screening and prevention of RIOM patients.

NCT ID: NCT06265025 Recruiting - Breast Cancer Clinical Trials

GM103 Intratumoral Injection in Patients With Locally Advanced, Unresectable, Refractory and/or Metastatic Solid Tumors

Start date: February 20, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to measure safety, tolerability, and preliminary antitumor efficacy of GM103 administered alone and in combination with pembrolizumab in patients with locally advanced, unresectable, refractory and/or metastatic solid tumors (including but not limited to head and neck cancer, malignant melanoma, CRC, renal cell carcinoma, cervical cancer, and breast cancer). Study details include: