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Head and Neck Neoplasms clinical trials

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NCT ID: NCT03955224 Withdrawn - Clinical trials for Upper Aerodigestive Tract Neoplasms

Evaluation of Low-Level Laser Therapy Efficacy in Pain Management of Grade 2 Oral Mucositis Induced by Radiotherapy or Chemoradiotherapy: a Study in Patients With Upper Aerodigestive Tract Cancer

ESMULLLAT
Start date: March 2021
Phase: Phase 2
Study type: Interventional

Prospective, monocentric, randomized phase II study evaluating Low-Level Laser Therapy (LLLT) as a treatment for the pain due to grade 2 oral mucositis in patients with upper aero-digestive tract cancer treated by radiotherapy or chemoradiotherapy. Patients with upper aero-digestive tract cancer receiving their first cervicofacial radiotherapy or chemoradiotherapy will be included in this study if they suffer from oral mucositis due to their treatment. The study procedure will consist in 5 applications of the LLLT that will be performed at three days intervals for a maximum duration of 15 days. Each patient will be followed until 3 days after the end of the study treatment, for a total duration of the study of 18 days.

NCT ID: NCT03953352 Withdrawn - Clinical trials for Head and Neck Cancer

Evaluation of the Automatic Deformable Recontouring on the Daily MVCT for Head and Neck Cancer Adaptive Radiotherapy

GIRAFE
Start date: August 2019
Phase: N/A
Study type: Interventional

This trial is a prospective, monocentric study aiming to evaluate an adaptive radiotherapy method (automatic deformable recontouring on the daily MVCT (MegaVoltage Computerized Tomography)) using the Precise ART™ software in patients with head and neck cancer. Patients will receive helical intensity-modulated radiotherapy (IMRT) according to the standard recommendations (35 fractions during 7 weeks). Radiotherapy will include daily repositioning MVCT. For the study, patients will undergo 4 intermediate re-planning CT-scan (without injection of intravenous contrast agent) at week 3, week 4, week 5 and week 6 of treatment. 3 recontouring modalities will be evaluated for the study: - Manuel recontouring (standard method) - Precise ART™ deformed contours - Precise RTX™ deformed contours The total duration of the study for each patient will be 7 weeks.

NCT ID: NCT03906838 Withdrawn - Surgery Clinical Trials

Regional Anesthesia Block in Fibula Free Flap Reconstruction

Start date: January 1, 2020
Phase: Early Phase 1
Study type: Interventional

Despite many recent advances in pain management, post-operative pain is widely considered to be poorly managed. Furthermore, the mainstay of current pain management is opioids, for which there is strong evidence of ill effects and long-term potential for addiction. There are many studies demonstrating that perineural regional anesthesia can be superior to intravenous opioid analgesia, and that the technique is safe. By using temporary implanted catheters, this method can now deliver prolonged analgesia, thus reducing the need for opioids in the postoperative period. Regional anesthesia is a proven technique and used daily by anesthesiologists, and it is also the first choice for hip and knee replacement surgery for orthopedic surgeons. Patients undergoing head and neck reconstruction with the use of free tissue transfer experience a significant amount of post-operative pain due to the complexity of the surgery, the presence of a head and neck surgical site as well as a secondary donor site, and existing co-morbidities, most commonly malignancy, that also cause significant pain. These patients often require opioids for pain control throughout the hospital stay, and are almost always discharged home with additional opioids. By utilizing regional anesthesia blocks at the donor sites, the investigators can potentially reduce post-operative pain while also reducing the use of opioids.

NCT ID: NCT03875833 Withdrawn - Clinical trials for Head and Neck Neoplasms

Prospective Analysis of Effect of Collagen Wrap Conduit on Radial and Ulnar Nerve Function Following Radial/Ulnar Forearm Free Flap Harvest

Start date: October 9, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether collagen nerve conduits placed on exposed radial and ulnar nerves during radial and ulnar forearm free flap harvests will reduce the occurrence and degree of sensory nerve deficit.

NCT ID: NCT03875053 Withdrawn - Clinical trials for Locally Advanced Head and Neck Squamous Cell Carcinoma

Home Sleep Apnea Machine in Evaluating Obstructive Sleep Apnea in Patients With Stage III-IV Head and Neck Cancer

Start date: July 25, 2023
Phase: N/A
Study type: Interventional

This trial studies information from a home sleep apnea machine to evaluate obstructive sleep apnea in patients with stage III-IV head and neck cancer. Sleep apnea (trouble breathing during sleep) can occur in head and neck cancer patients who have swelling in their neck. Wearing a sleep apnea machine overnight may help doctors evaluate obstructive sleep apnea in patients with head and neck cancer.

NCT ID: NCT03747562 Withdrawn - Pain, Neuropathic Clinical Trials

Study of Efficacy and Safety of Gabapentin to Reduce the Need for Strong Opioid Use in Head and Neck Cancer Patients.

stREnGTH
Start date: March 1, 2019
Phase: Phase 3
Study type: Interventional

A multi-centre, double-blind, randomized-controlled trial to study the efficacy and safety of gabapentin to reduce the need for strong opioid use in the treatment of radiation-induced pain in head and neck cancer (HNCA) patients undergoing a curative 7-week radio(chemo)therapy course with curative intent. The aim of this study is to establish if addition of gabapentin is more effective in reducing the need to start (or dosage-increase) a strong opioid for HNCA pain than a matching placebo additional to standard pain management (WHO-ladder step 2 and 3).

NCT ID: NCT03745690 Withdrawn - Clinical trials for Head and Neck Carcinoma

Near-Infrared Image Guided Surgical Resection With Indocyanine Green in Treating Patients With Head and Neck Cancer

Start date: December 12, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

This phase Ib/II trial studies the side effects of near-infrared image guided surgical resection with indocyanine green in treating patients with head and neck cancer. Near-infrared image guided surgical resection with indocyanine green may make it easier to find and remove tumors.

NCT ID: NCT03714867 Withdrawn - Clinical trials for Head and Neck Cancer

Pre-Operative Pregabalin for Post-Operative Pain in Head and Neck Cancer Surgery

Start date: March 22, 2019
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate and reduce pain and improve quality of life in patients being treated for head and neck cancer with primary tumor resection and bilateral neck dissections. Patients will be randomly assigned to receive either pre-operative pregabalin (Lyrica) or a placebo. Patients and investigators will be blinded to which medication patients receive, and all patients will receive the same postoperative pain medication regimen with appropriate pain treatment as needed. Patients will be asked to fill out surveys prior to surgery, while in the hospital after surgery, and at each follow-up appointment for up to 24 months.

NCT ID: NCT03707860 Withdrawn - Clinical trials for Head and Neck Cancer

Radiation Oncology Mobile Application

?-App
Start date: February 1, 2019
Phase:
Study type: Observational

To develop a novel a mobile phone application (available on Android and IOS) for patients receiving radiation treatment for head and neck cancer. Through this application, patients will get access to their treatment calender, through a system connected with Mosiac database, which provides a timely and precise access to their treatments schedule. In addition, patients will be able to report their treatment related toxicity in real time fashion, these symptoms will be addressed daily instead of the weekly floor clinic checks. Furthermore, the radiation oncologist will receive an instant notification through the application, if there is error in patient's treatment (missing field, wrong dose, etc..)

NCT ID: NCT03561324 Withdrawn - Clinical trials for Head and Neck Neoplasms

Intraoperative Imaging of a PET Positive Lymph Node(s) Using 18FDG and a Dual-Mode, Hand-Held Intraoperative Imager

Start date: June 20, 2018
Phase: N/A
Study type: Interventional

This study is a prospective collection of data utilizing the Imaging Beta Probe (IBP) in patients with positron emission tomography (PET) positive disease. A pilot clinical study involving 5 patients will be conducted using the IBP. The sterilized IBP will be used intraoperatively in surgical wounds for localization of tumor sites and detecting completeness of excision vs. positive margins. The outcome of each of these studies will be documented and used to demonstrate clinical benefits of the new probe. The investigators will correlate the images from the probe of the Fludeoxyglucose (18FDG) positive tissue, both in-vivo and ex-vivo after dissection, with the previously performed PET scan and with the routine pathology results obtained on the surgical specimens.The experimental imaging modality studied in this protocol will be compared to clinically utilized modalities of ultrasound and PET/ CT. Localization between imaging modalities will be compared with respect to: detection and side of localization.