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Mouth Neoplasms clinical trials

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NCT ID: NCT05865548 Recruiting - Oral Cancer Clinical Trials

Addition of Aspirin to Standard of Care in Oral Cancer

Start date: May 17, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

Despite accumulating evidence of the benefit of aspirin in cancer, its effect on improving cancer survival is still debated since the mechanism by which it impacts cancer survival is not completely understood and the published data are discordant. There have been 4 randomized controlled trials (RCT) showing mixed results from no effect to improved survival. Several retrospective and observational studies have reported a survival advantage of adding aspirin to the treatment for various cancers. A meta-analysis of 118 studies, 63 of them specifically reporting on cancer mortality and the rest on all-cause mortality, found a 21% reduction in cancer deaths and about 20% reduction in all-cause mortality (pooled hazard ratio (HR): 0.79; 95% confidence intervals: 0.73, 0.84). However, the evidence is still lacking and there is need to do more RCT

NCT ID: NCT05837221 Recruiting - Clinical trials for Head and Neck Cancer

Microbiome in Head and Neck Squamous Cell Carcinoma

Start date: December 2024
Phase:
Study type: Observational

This study aims to determine whether dysbiosis actively contributes to HNSCC and if so, the underlying molecular mechanisms.

NCT ID: NCT05833841 Completed - Oral Cancer Clinical Trials

Swallowing Function in Patients With Head and Neck Cancers

Start date: May 1, 2021
Phase: N/A
Study type: Interventional

Head and neck cancer (HNC) is the sixth most common cancer worldwide, accounting for 2.8% of all malignancies. The presence of tumor itself, as well as the treatment, can result in neuromuscular damage affecting any stage of the swallowing. Organ-sparing care has become more common in recent years, however, that this does not always imply functional preservation. Dysphagia and aspiration both can occur and can have complex causes. Normal swallowing has oral preparatory phase, pharyngeal phase, and the oesophageal phase, it is important to know what is the dysfunction and where. This study aim to evaluate the preoperative and postoperative swallowing function in patients with head neck cancer using electromyography (EMG) and video fluoroscopy.

NCT ID: NCT05798780 Recruiting - Oropharynx Cancer Clinical Trials

The ENHANCE Study: Exercise and Nutrition in Head And Neck CancEr Survivors

Start date: April 6, 2023
Phase: N/A
Study type: Interventional

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

NCT ID: NCT05793151 Recruiting - Clinical trials for Head and Neck Cancer

Multi-Site Trial of Navigation vs Treatment as Usual for Delays in Starting Adjuvant Therapy

ENDURE
Start date: October 30, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare the effectiveness of a navigation-based multilevel intervention (ENDURE) with treatment as usual at decreasing delays starting guideline-adherent postoperative radiation therapy among patients with head and neck cancer. The main questions the trial aims to answer are: - Does ENDURE decrease delays starting PORT relative to treatment as usual? - Does ENDURE decrease racial disparities in delays starting PORT relative to treatment as usual - What are the mechanisms through which ENDURE reduces treatment delays?

NCT ID: NCT05774483 Not yet recruiting - Mouth Neoplasms Clinical Trials

Sentinel Node Biopsy Versus Limited Elective Neck Dissection in Early Cancers of Oral Cavity NoDe Negative

SECOND N0
Start date: April 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare the survival outcomes, morbidity and cost-effectiveness of sentinel node biopsy versus limited elective neck dissection in node-negative early oral cancers. The main questions it aims to answer are: - Survival outcomes - Morbidity outcomes - Cost-effectiveness Participants will either undergo sentinel node biopsy followed by completion neck dissection if sentinel node is reported to be metastatic (SNB) or limited elective neck dissection where level IIb will be cleared only if level IIa is metastatic (limited END). The study will compare the outcomes in the two cohorts.

NCT ID: NCT05766150 Recruiting - Oral Cancer Clinical Trials

Oral Microbioma and Oral Malignant Disease

Start date: December 1, 2021
Phase:
Study type: Observational

This case-control study aims to investigate if oral microbioma is associated with developing oral (pre)malignant disease.

NCT ID: NCT05757817 Recruiting - Clinical trials for Head and Neck Cancer

Evaluation of the Benefit of a New Surgical Procedure According to IDEAL Recommendations for ORL Cancer Patients: the External Pudendal Flap Used as a New Free Flap for Oral Cavity/Oropharyngeal Reconstruction to Limit Donor Site Sequelae

LAMBEAU STEPA
Start date: November 8, 2023
Phase: N/A
Study type: Interventional

This is a phase 1b, multicenter, non-randomized prospective study involving an innovation phase (IDEAL-1) followed by a prospective development phase (IDEAL-2A) designed to evaluate the safety and feasibility of oral/oropharyngeal reconstruction with the external pudendal free flap in two groups of patients. A maximum of 40 patients (20 patients per group) will be included in this IDEAL-1/2A phase study. Stage IDEAL-1: Innovation phase. The main objective is to evaluate the feasibility in terms of limiting surgical complications of a STEPA flap reconstruction in two groups of patients (Cohort: Male, Female). Stage IDEAL-2A: Prospective development phase. The main objective is to describe the complication profile of the surgical procedure in these two patient populations. Each patient will be followed during 12 months after the end of complete treatment (surgery ± adjuvant treatment). A complementary study (observational study) of 250 patients will also be conducted to evaluate the acceptability of the technique (reconstruction by external pudendal flap) by the patients and to describe the factors associated with this acceptability.

NCT ID: NCT05740033 Recruiting - Oral Cancer Clinical Trials

Radial Forearm Donor Site Closure

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

The radial forearm free flap (RFFF) is widely used in head and neck reconstruction. Its thinness, pliability, pedicle length, and vessel size are particularly suited for oropharyngeal and oral cavity reconstruction. Concerns about aesthetic and functional morbidity at the donor site have given rise to various techniques of closing the donor site, two of which are the split-thickness skin graft (STSG), taken from the thigh, and the hatchet flap, which uses a local flap within the radial forearm. This RCT will determine whether retrospectively reported improvements to aesthetic and functional outcomes for STSG patients are greater compared to hatchet flap patients.

NCT ID: NCT05721755 Recruiting - Clinical trials for Metastatic Head and Neck Squamous Cell Carcinoma

Combining Radiation Therapy With Immunotherapy for the Treatment of Metastatic Squamous Cell Carcinoma of the Head and Neck

Start date: June 8, 2023
Phase: Phase 3
Study type: Interventional

This phase III trial compares pembrolizumab with radiation therapy to pembrolizumab without radiation therapy (standard therapy) given after pembrolizumab plus chemotherapy for the treatment of patients with squamous cell carcinoma of the head and neck that has spread from where it first started (primary site) to other places in the body (metastatic). Pembrolizumab is a type of immunotherapy that stimulates the body's immune system to fight cancer cells. Pembrolizumab targets and blocks a protein called PD-1 on the surface of certain immune cells called T-cells. Blocking PD-1 triggers the T-cells to find and kill cancer cells. Radiation therapy uses high-powered rays to kill cancer cells. Giving radiation with pembrolizumab may be more effective at treating patients with metastatic head and neck cancer than the standard therapy of giving pembrolizumab alone.