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Head and Neck Neoplasms clinical trials

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NCT ID: NCT04922112 Withdrawn - Clinical trials for Obstructive Sleep Apnea

Sleep Apnea in Head and Neck Cancer Patients at the University of Colorado

OSA-HN
Start date: April 20, 2021
Phase: N/A
Study type: Interventional

Obstructive sleep apnea (OSA) is increasingly recognized in patients with squamous cell carcinoma of the head and neck (SCCHN). The prevalence prior and after cancer therapy is not well understood. OSA is identified as a contributing factor for daytime somnolence and quality of life (QOL), yet treatment of OSA in the SCCHN population has not been studied. The investigators hope to identify the disease course of sleep apnea, risk factors for development, and impact on QOL with treatment of OSA in a population of patients with SCCHN.

NCT ID: NCT04892875 Withdrawn - Clinical trials for Head and Neck Cancer

A Study of Concurrent Chemoradiation in Combination With or Without PD1 Inhibitor AB122 Adenosine 2a Receptor / Adenosine 2b Receptor Inhibitor AB928 Therapies in Locally Advanced Head and Neck Cancers

PANTHEoN
Start date: December 31, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to test the safety and tolerability of chemotherapy and radiation in combination with the investigational study drugs zimberelimab (AB122) and etrumadenant (AB928) in subjects with a locally advances head or neck cancer. The study will also ask how the study drugs change the following: - The microbiome that lives in the mouth and on the skin - Immune cells as they respond to a skin wound - Scarring (fibrosis) caused by radiation After completing a screening phase, subjects will be assigned to one of three cohorts: - Cohort 1: Subjects who will receive cisplatin, radiation and zimberelimab followed by zimberelimab only. - Cohort 2: Subjects who will receive cisplatin, radiation, zimberelimab and etrumadenant followed by zimberelimab and etrumadent. - Cohort 3: Subjects who will receive cisplatin and radiation followed by an observation period. All three cohorts will be followed for a 24 months following the conclusion of the chemoradiation.

NCT ID: NCT04679233 Withdrawn - Radiotherapy Clinical Trials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: NCT04607642 Withdrawn - Clinical trials for Head and Neck Cancer

Trial of BMX-001 or Placebo in Head and Neck Cancer Patients

Start date: July 2021
Phase: Phase 2
Study type: Interventional

There are an estimated 65,000 newly diagnosed cases of head and neck cancer each year in the United States. The most common treatment for head and neck cancers is radiotherapy in combination with cisplatin chemotherapy. This treatment regimen is effective in killing the tumor; however, the normal tissues that line the mouth and throat can sustain severe injury from the radiation. Side-effects incurred during irradiation include: mucositis, xerostomia, swelling, trouble swallowing, pain, infections, cavities, hair loss and reddening of the skin. Some of these side effects can be so severe that patients require feeding tubes and management of severe pain can lead to the premature halt of radiotherapy. There are currently no effective radio-protectors used to ameliorate these severe side-effects. BioMimetix has developed small molecular weight superoxide dismutase (SOD) mimetic, BMX-001, that is a very potent radio-protector of head and neck tissues. In our first clinical trial in a head and neck cancer patient cohort using this drug, we have early evidence that BMX-001 may protect against radiation-induced mucositis and xerostomia. This will be a randomized, placebo-controlled Phase 2 clinical trial to study the effects of BMX-001 (14 mg/subject biw) + radiation therapy + cisplatin against placebo + radiation therapy + cisplatin in prevention of acute and chronic mucositis and xerostomia.

NCT ID: NCT04593914 Withdrawn - Clinical trials for Head and Neck Cancer

A Novel Skin Barrier Protectant for Acute Radiodermatitis

CASP-ORL
Start date: September 1, 2020
Phase: N/A
Study type: Interventional

Acute radiodermatitis (ARD) is a distressing and painful skin reaction that occurs in 95% of the patients undergoing radiotherapy (RT). To date, there is still no general approved guideline for the prevention and management of acute radiodermatitis. The 3M™ Cavilon™ Advanced Skin Protectant is a novel skin barrier protectant that acts as a physical barrier against abrasion, moisture, and irritants. Moreover, it enables an environment for wound healing. The aim of this study is to evaluate the effectiveness of 3M™ Cavilon™ Advanced Skin Protectant in the prevention and management of ARD in patients with head and neck cancer.

NCT ID: NCT04449445 Withdrawn - Clinical trials for Head and Neck Cancer

Perioperative Nutritional Optimization in Head and Neck Cancer Patients

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

To determine whether nutritional optimization in head and neck cancer patients undergoing major surgery will decrease post-operative wound complications. The Investigators hypothesize that nutritional supplementation with Nestle Impact Advanced Recovery (AR) will decrease the rate of wound complications after surgery

NCT ID: NCT04408898 Withdrawn - Clinical trials for Head and Neck Cancer

SPEARHEAD 2 Study in Subjects With Recurrent or Metastatic Head and Neck Cancer

Start date: July 2, 2020
Phase: Phase 2
Study type: Interventional

This is a study to investigate the efficacy and safety of ADP-A2M4 in combination with pembrolizumab in HLA-A*02 eligible and MAGE-A4 positive subjects with recurrent or metastatic Head and Neck cancer.

NCT ID: NCT04276454 Withdrawn - Clinical trials for Head and Neck Cancer

Lymphedema Treatment in Head and Neck Cancer Patients

Start date: April 23, 2020
Phase: N/A
Study type: Interventional

The purpose of this research is to evaluate the result of treatment for neck lymphedema on throat pressure in patients who have received radiation therapy for head and neck cancer.

NCT ID: NCT04058145 Withdrawn - Clinical trials for Head and Neck Cancer

AMD3100 Plus Pembrolizumab in Immune Checkpoint Blockade Refractory Head and Neck Squamous Cell Carcinoma

Start date: September 30, 2019
Phase: Phase 2
Study type: Interventional

This research is studying the safety and effectiveness of AMD3100 and pembrolizumab in participants with metastatic head and neck squamous cell carcinoma.

NCT ID: NCT03982537 Withdrawn - Clinical trials for Head and Neck Cancer

Effect of N-Acetyl Cysteine (NAC) on the Oral Microbiome

Start date: June 18, 2020
Phase: Phase 2
Study type: Interventional

This is a Phase II treatment, randomized 3:1 ratio, open label clinical trial to study the effect of short duration administration of N-acetyl cysteine on oral microbiome and on mucositis caused by concurrent chemotherapy and radiotherapy.