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Head and Neck Neoplasms clinical trials

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NCT ID: NCT05269160 Recruiting - Breast Cancer Clinical Trials

Topical Dermaprazole for Radiation Dermatitis in Breast Cancer and Head and Neck Cancer Patients (TOPAZ)

Start date: April 24, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

Radiotherapy is a mainstay of treatment in head and neck cancer and breast cancer treatment, typically following surgery and/or chemotherapy. Radiation dermatitis, which involves redness, dryness, and/or peeling of the skin, occurs in up to 95% of patients receiving radiation therapy. There is currently no standard therapy for this treatment-related adverse effect. The aim of this study is to investigate the safety and tolerability (Phase I) and preliminary efficacy (Phase II) of prophylactic esomeprazole cream ( termed "Dermaprazole") in patients who require radiation for either breast cancer in the postmastectomy setting or head and neck cancer in the definitive or adjuvant setting.

NCT ID: NCT05260671 Recruiting - Metastatic Cancer Clinical Trials

Penpulimab in Combination With Cetuximab as First-line Treatment in R/M SCCHN

Start date: January 25, 2022
Phase: Phase 2
Study type: Interventional

This trial is a multicenter, prospective, single-arm exploratory clinical study to evaluate the efficacy and safety of Penpulimab injection combined with cetuximab in the first-line treatment of recurrent/metastatic squamous cell carcinoma of the head and neck.

NCT ID: NCT05256238 Recruiting - Clinical trials for Head and Neck Cancer

Effect of Exercise in Head and Neck Cancer Patients

EffEx-HN
Start date: January 25, 2022
Phase: N/A
Study type: Interventional

Head and neck cancers (HNC) are malignancies originating from the mucosa in the oral cavity, nasopharynx, oropharynx, hypopharynx and larynx. Unfortunately, the majority of patients with HNC have locally advanced disease at diagnosis and should, therefore, be treated with chemoradiotherapy (CRT) or with radical surgery followed by adjuvant (C)RT. Treatment of HNCs with (C)RT frequently results in serious and persistent impairments in physical and psychosocial functioning. In order to prevent worsening of a person's functioning at diagnoses and limit the physical impact of the treatments for HNC, a comprehensive supervised exercise program (CSEP) is needed early during treatment. There is a need to improve integration of exercise programs into HNC care with aim to help head and neck cancer patients regain physical, mental and social functioning. Currently, no program is available adapted to the specific needs of head and neck cancer patients, in particular during cancer treatment. The primary scientific objective is to examine the effectiveness of a comprehensive supervised exercise program, in addition to usual care, on health-related quality of life (primary outcome parameters) during treatment of head and neck cancer, compared to usual care only, up to 1 year after diagnosis. Secondary objectives entail gathering information on the effectiveness of the CSEP, in addition to usual care on secondary outcome parameter such as physical and mental functioning, activity level and participation level; to determine the feasibility of such CSEP (defined as at least 50% of eligible patients enrolling in the study and completing at least 50% of the planned intervention sessions) and possible barriers and facilitators for participating in a CSEP during head and neck cancer treatment.

NCT ID: NCT05246475 Recruiting - Clinical trials for Head and Neck Cancer

Measurement of Head and Neck Tumor Hypoxia With PET-MRI

EF5NECK
Start date: February 8, 2022
Phase: N/A
Study type: Interventional

This study is designed to evaluate the performance of advanced magnetic resonance (MR) imaging in the assessment of tumor hypoxia using [18F]EF5 positron emission tomography (PET) as a reference in head and neck cancer patients. Low oxygen level or hypoxia contributes to radiotherapy resistance. Therefore, a clinically applicable method to detect tumor hypoxia is of great importance.

NCT ID: NCT05245682 Recruiting - Clinical trials for Locally Advanced Head and Neck Squamous Cell Carcinoma

Tolinapant and Radiation for Cisplatin-Ineligible, Previously Untreated, Locally Advanced Head and Neck Cancer

Start date: February 17, 2022
Phase: Early Phase 1
Study type: Interventional

This early-phase trial tests the safety and side effects of a tolinapant given together with radiation therapy in treating patients with head and neck cancer for which the patient has not received treatment in the past (previously untreated), has spread to nearby tissue or lymph nodes (locally advanced) and cannot receive cisplatin (cisplatin-ineligible). Tolinapant may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving tolinapant and radiation therapy may kill more tumor cells.

NCT ID: NCT05239000 Recruiting - Clinical trials for Head and Neck Cancer

A Study Comparing Geriatric Co-Management With Geriatric Guided Supportive Care in Older Patients Receiving Chemoradiation Therapy for Their Head and Neck Cancer

Start date: February 3, 2022
Phase: N/A
Study type: Interventional

The researchers are doing this study to see whether geriatric co-management or geriatric guided supportive care are good approaches for managing side effects in older patients who have head and neck cancer and are receiving chemoradiation therapy. This study will provide valuable information about different ways to manage side effects in older patients receiving chemoradiation therapy.

NCT ID: NCT05226871 Recruiting - Breast Cancer Clinical Trials

Study for Participants Continuing From Pfizer-sponsored Palbociclib (a Study Medicine) Studies

Start date: July 7, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this clinical trial is to provide study medicine(s) and learn about their safety. This study is seeking participants who: - Have benefited from ongoing study treatment as determined by the study doctor in a Pfizer-sponsored palbociclib Parent Study - Must agree to follow the reproductive criteria - Are willing and able to comply with all scheduled visits, treatment plans, and other study procedures - Can give signed informed consent documents Participants in this study will continue to receive treatment as they were in the parent study. The time by which participants will take part in this study is retrospective (after completed parent study). We will examine the experiences of people receiving the study medicine(s). This will help us determine if the study medicine(s) are safe. During this time, the participants will be monitored for the safety of the study medicine(s).

NCT ID: NCT05217212 Recruiting - Clinical trials for Head and Neck Squamous Cell Carcinoma

Do Markers of Systemic Inflammatory Response and Tumor Metabolism Indicate Radioresistance in Head and Neck Cancer?

Start date: January 1, 2020
Phase:
Study type: Observational

The aim of the study is to prospectively evaluate whether markers of a patient's systemic inflammatory response in addition to FDG-PET/CT metabolic parameters of the primary tumor or of nodal metastases can predict radioresistance and survival before primary radiochemotherapy in advanced head and neck cancer patients.

NCT ID: NCT05200650 Recruiting - Clinical trials for Head and Neck Cancer

A Single Arm, Prospective, Open Label, Multi Center, Phase Ib Study to Evaluate the Safety, Tolerability and Initial Efficacy of a Single Intra-tumoral Injection of IntraGel's Polymer-based Cisplatin-loaded Gel (TumoCure) in Subjects With Progressive or Radio-resistant Primary Head and Neck Tumor

Start date: January 15, 2023
Phase: Phase 1
Study type: Interventional

IntraGel's polymer-based Cisplatin loaded Gel (TumoCure) is a single injectable compound, aimed at localized chemotherapy treatment. The treatment is offered to patients who currently have no other available treatment options, either due to inefficacy, intolerability or inapplicability of standard treatment

NCT ID: NCT05187091 Recruiting - Clinical trials for Head and Neck Neoplasms

The SWOAR Trial Sparing of Swallowing and Aspiration Related Organs at Risk & Submandibular Gland With Intensity Modulated Radiotherapy Versus Standard IMRT in Head and Neck Squamous Cell Carcinomas

SWOAR
Start date: July 11, 2021
Phase: Phase 3
Study type: Interventional

The aim of SWOAR TRIAL is to test sparing of Dysphagia/ Aspiration risk structures (DARS) and contra lateral submandibular gland by IMRT. HNSCC of the oropharynx, larynx and the hypopharynx treated with radical concurrent chemoradiotherapy or radiotherapy will be included in the trial. Patients will be randomized to SWOAR IMRT or standard IMRT. Swallowing function will be evaluated the MD Anderson Dysphagia Inventory (MDADI) scoring. Difference in the mean composite score of MDADI, a patient-reported outcome, at 6 months post radiotherapy is the primary outcome of the trial. Secondary Objectives include longitudinal assessment of aspiration prevention as evaluated by FEES by the 8 point penetration-aspiration score. Swallowing function, will be assessed by using the MDADI at baseline, at completion of CRT/RT, 3, 6, 12, and 24 months. Assessment of acute and late toxicity assessed at baseline, weekly during radiotherapy and then at 3, 6, 12, and 24 months post treatment as per RTOG and LENT SOMA score, respectively. Treatment outcomes will be assessed in terms of loco-regional tumor recurrence and overall survival, assessed at follow-up visits 3, 6, 12, and 24 months post treatment and then annually until 5 years post treatment.