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Head and Neck Neoplasm clinical trials

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NCT ID: NCT05590650 Completed - Chemoradiotherapy Clinical Trials

A Pilot Study of Additional Chinese Formula for Concurrent Chemoradiotherapy in Oral Cavity Cancer Patients

Start date: July 7, 2018
Phase: Phase 1
Study type: Interventional

The goal of this clinical trial is to learn about the clinical efficacy of San-Zhong-Kui-Jian-Tang (SZKJT), a formula of Chinese medicine in head and neck cancer patients receiving concurrent chemoradiotherapy (CCRT) treatments. The main questions it aims to answer are: - Can SZKJT improve the completion rate of CCRT? - Can SZKJT reduce the adverse effects of CCRT? - How SZKJT affect the quality of life in the patients receiving CCRT - How about the safety of using SZKJT in the patients receiving CCRT Participants will be asked to: - take SZKJT for 9 weeks during the whole CCRT course - take questionnaires of quality of life

NCT ID: NCT05011500 Recruiting - Clinical trials for Head and Neck Neoplasm

Masks Against Surface-Scanning for Radiation Therapy Immobilisation in Head and Neck Cancer (MASSC)

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

The purpose of this study is to investigate the feasibility of using open masks or no masks in combination with optical surface scanning for radiotherapy in patients with head and neck cancer.

NCT ID: NCT04679233 Withdrawn - Radiotherapy Clinical Trials

Feasibility and Safety of Aerobic Exercise for Head and Neck Cancer Patients

Start date: February 2021
Phase: N/A
Study type: Interventional

Treated head and neck cancer patients are subject to tissue swelling and scarring, known as lymphedema and fibrosis (LEF). LEF in the head and neck cancer patient occurs in up to 90% of treated patients and is associated with inflammation cells. Aerobic exercise is known to mediate these same inflammatory cells in an anti-inflammatory manner due to chronic adaptation of the cells. The investigators are therefore proposing a prescription exercise study for head and neck cancer patients. This study's primary aim is feasibility and safety of the aerobic exercise prescription. Feasibility of gathering study participant inflammation markers, visible LEF, and patient LEF symptoms will be a secondary aim of the study. Patient will be asked to journal their experience for a qualitative analysis. The prescription aerobic exercise is that of high intensity interval exercise, since this form of exercise can achieve similar or better results to moderate exercise with less time and patient burden. Each exercise session will take place on a cycle ergometer, will be 5 minutes warm up, 5 minutes cool down, and 20 minutes of exercise (1 minute intervals alternated by 1 minute rests x 10 each).

NCT ID: NCT04477759 Recruiting - Clinical trials for Head and Neck Neoplasm

Dose-Escalated Hypofractionated Adaptive Radiotherapy for Head and Neck Cancer

DEHART
Start date: January 26, 2021
Phase: Phase 1
Study type: Interventional

Locoregional failure remains the principal mode of mortality in head and neck squamous cell carcinoma (HNSCC) treated with conventional chemoradiation therapy. Magnetic resonance-guided radiation therapy (MRgRT) allows for adaptive radiation dose escalation based on tumor response and may improve therapeutic outcomes while limiting toxicities. This protocol evaluates a novel framework for radiation delivery with concurrent atezolizumab in patients with advanced HNSCC. Dose-Escalated Hypofractionated Adaptive Radiotherapy (DEHART) modifies radiation dose using MRgRT by escalating radiation dose to residual tumor while deescalating radiation dose to areas of tumor regression.

NCT ID: NCT04277273 Completed - Cleft Palate Clinical Trials

Characteristics of a Maxillofacial Prosthesis Consultation Within Assistance Publique - Hopitaux de Paris

PEC-PMF
Start date: November 13, 2020
Phase: N/A
Study type: Interventional

Patients treated with Maxillofacial Prosthesis have loss of maxillary and/or mandibular substances. Few data are available on quality of life of these patients and its association with some of their socio-demographic, medical and clinical characteristics.

NCT ID: NCT04267627 Not yet recruiting - Survivorship Clinical Trials

Telemedicine Nurse-Led Intervention for Rural Cancer Survivors

CARING
Start date: December 31, 2020
Phase: N/A
Study type: Interventional

This study will evaluate the impact, cost-effectiveness, and patient perspectives of Comprehensive Assistance: Rural Intervention, Nursing, and Guidance (CARING), a nurse-led supportive care protocol delivered using telemedicine videoconferencing aimed at reducing unmet needs in a rural head and neck cancer population. Specific aims: 1) Test the efficacy of CARING, delivered with and without telemedicine, compared to a control group. 2) Conduct a cost-effectiveness analysis of a nurse-led telemedicine visit. 3) Evaluate patient perceptions of a telemedicine intervention. Design: We will use a three-arm randomized control design to determine the efficacy of CARING delivered face-to-face, vs. CARING over telemedicine, vs. usual care. Costs will be determine for incremental cost effectiveness analysis, with quality of life years as the effectiveness variable. Patient perceptions will be evaluated qualitatively using the Practical, Robust Implementation and Sustainability Model (PRISM), designed to evaluate translation of research into practice and quantitatively using the Telemedicine Satisfaction and Usefulness Questionnaire (TSUQ). Sample: We will enroll 450 head and neck cancer survivors of any stage who have completed treatment within the last 6 weeks (address over sampling of rural). Procedures: Following randomization, those in the intervention arm will either receive the nurse-led intervention in a clinic setting or over telemedicine videoconferencing 6 weeks following their in-person, end of treatment medical visit. Assessments at baseline, 6 weeks following the intervention, and 6 months following the intervention will document unmet needs using the Short Form Survivorship Unmet Needs (SF-SUNS) and quality of life using the Functional Assessment of Cancer Therapies- Head and Neck (FACT-HN) and the TSUQ and PRISM-guided questionnaires immediately following intervention. Health utilization costs at the societal and health system levels will be collected from the electronic medical record and patient interviews.

NCT ID: NCT04151030 Completed - Gastrostomy Clinical Trials

Endoscopic Direct-PEG Placement in Patients Unable to Undergo Pull-PEG Procedure

PEG
Start date: June 28, 2019
Phase: N/A
Study type: Interventional

Placement of a feeding tube through a gastrostomy can be performed endoscopically or radiologically. While percutaneous endoscopic gastrostomy (PEG) tube placement is most frequently performed using a "pull" technique, this method may not feasible in patients with malignant, or tight benign, esophageal stenosis. Further, the "pull" technique may drag tumor cells with the feeding tube and lead to implantation metastasis at the gastrostomy site. A clinical practice update by the American Gastroenterological Association has recommended that the pull-through PEG placement method should be avoided in all patients with oropharyngeal or esophageal cancer. It also recommends that the introducer/Push PEG method should be favored instead of the pull PEG. In such situations, an introducer-style, "Direct" gastrostomy tube can be placed endoscopically or radiologically. However, the published data comparing outcomes and safety of endoscopic "Direct" PEG (D-PEG) and interventional radiological PEG (IR-PEG) are very sparse. The D-PEG is performed under endoscopic visualization of the gastric wall which facilitates greater control and allows safe selection of gastrostomy site. Further, the presence of an endoscope enables transillumination to confirm the absence of intervening abdominal viscera between the abdominal wall and the anterior wall of the stomach. These advantages are lacking with the IR-PEG. We hypothesize that D-PEG is safer than IR-PEG. In this single center, non-randomized study, patients unable to undergo a conventional per-oral "Pull" PEG and needing a D-PEG will be prospectively enrolled. For the comparison arm, historical IR-PEG procedures at our center will be assessed. The technical success and rates of adverse events will be compared between the two arms. Approval from the Institutional review board has been obtained. Based on our experience, we estimate a sample size of 40 participants in each arm and anticipate completion of this pilot study by June 2021.

NCT ID: NCT04099290 Recruiting - Clinical trials for Carcinoma, Squamous Cell

Circulating Tumor DNA (ctDNA) in Locally Advanced Head and Neck Squamous Cell Carcinoma

Start date: January 14, 2020
Phase:
Study type: Observational

Circulating tumor DNA (ctDNA) is a blood-based test that measures dying or dead cancer cells that are already circulating in the blood. In this study, the investigators will enroll patients who are planning to receive surgery to remove their head and neck cancer. The investigators are interested to learn how ctDNA levels change with surgery and over the course of time. The investigators also want to determine if there are certain features of the tumor or the patient themselves that might cause ctDNA to be higher than other patients. Also, the investigators want to explore if the detection of ctDNA following surgery is related to cancer recurrence.

NCT ID: NCT04086849 Completed - Clinical trials for Squamous Cell Carcinoma of Head and Neck

Analysis of Patterns of Recurrence in Head and Neck Cancer Using Clinicopathomic Markers

Start date: July 30, 2019
Phase:
Study type: Observational

Here, the investigators will develop a clinicopathomic assay from biomarkers obtained from digital pathologies of resected whole-mount oral cavity and oropharyngeal squamous cell carcinoma (OCSCC and OPSCC) specimens with the goal of administering personalized novel image-guided therapies immediately after primary surgical management in OCSCC and OPSCC patients. The primary aim is to determine the association between clinicopathomic biomarkers and LRR. The secondary aim is to develop a clinicopathomic risk score (assay) such that a decision-support tool can be used by physicians for measuring the benefit of additional therapies (i.e. conventional chemotherapy +/- radiation or administering dose-escalated chemoradiation) in the adjuvant setting to reduce LRR rates.

NCT ID: NCT04005521 Active, not recruiting - Clinical trials for Deglutition Disorders

Randomized Study Regarding Preventive Jaw- and Swallowing Intervention for Patients With Head and Neck Cancer

HNC
Start date: June 13, 2019
Phase: N/A
Study type: Interventional

The study includes patients with tumors of the oropharynx, larynx and hypopharynx scheduled to receive radiotherapy with curative intent (+/- chemotherapy). The patients will be randomized into either an intervention group (performing a preventive jaw- and swallowing exercise protocol before and during radiotherapy) or a control group no performing a exercise protocol. All patients will be encouraged to eat or drink for as long as possible during the therapy. All patients will meet with a speech-language therapist weekly during radiotherapy.