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Head and Neck Neoplasms clinical trials

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NCT ID: NCT06457594 Completed - Clinical trials for Head and Neck Cancer

Prospective PROM and PREM Analysis Demonstrating Specification Advantage and Language Barriers

Start date: January 1, 2022
Phase:
Study type: Observational [Patient Registry]

Importance: Patient reported outcome and experience measures (PROM and PREM) constitute a cornerstone of the collective efforts to improve and personalize healthcare systems. The EORTC quality of life (QOL) group developed instruments evaluating general and disease specific oncology QOL questionnaires, and the quality of information received. Implementation of PREM and relevant PROM is essential for equity, better resources utility, accessibility and patient centered treatment. Objectives: We describe the EORTC INFO 25 translation process followed by investigation of subpopulation where action is most needed. We investigate which QOL questionnaire better reflects clinical parameters among head and neck cancer (HNC) patients. Design: A prospective cohort. Setting Tertiary, referral, head and neck dedicated surgical service. Participants: Consecutive head and neck cancer adult patients, surgically treated, recruited between January to December 2022. Exposures: We prospectively analyzed the new EORTC INFO 25 Hebrew questionnaire together with previously established Arabic translated version and the general (QLQ-C30) and specific (QLQ - H&N43) oncology QOL questionnaires. Main Outcomes and Measures: Analyzing the quality of information provided and desired in diverse HNC subgroup of patients. Analyzing which of PROM questionnaire better reflects HNC patients' disease and treatment parameters, which in turn, may predict poorer QOL. Results: We recruited 60 patients, consisting of equal female: male ratio, of which 16.66% were native Arabic speaking. Validated INFO 25 scores (median 62.6±17.5) were not associated with patients' age, sex, education status, disease, and treatment parameters. Yet, the Arabic spoken sub-population had significantly lower scores (p<0.001). In contrast to QLQ-C30, clinical imperative associations were demonstrated between QLQ - H&N43 and patients' disease stage (P<0.001), admission days (p<0.0001), free flap reconstruction (P<0.001) and adjuvant radiotherapy (P<0.001). Conclusions and relevance: The final version of the native EORTC INFO25 translation was approved by the EORTC. We demonstrate lower INFO25 scores among the Arabic speaking population, suggesting frail equity and accessibility. In order to improve patients' centered treatment and resource utilization, we reveal a strong association between disease severity and treatment aggressiveness and poor quality of life on specific, HNC oriented, EORTC QLQ - H&N43 questionnaire that was not validated on EORTC QLQ-C30, which can be omitted.

NCT ID: NCT06446570 Completed - Clinical trials for Head and Neck Neoplasms

Phase II Study of Durvalumab(MEDI4736) + Tremelimumab in Pulmonary Sarcomatoid Carcinoma

Start date: September 10, 2017
Phase: Phase 2
Study type: Interventional

Phase II study of Durvalumab+/- Tremelimumab in patients with recurred metastatic head and neck squamous cell carcinoma

NCT ID: NCT06428994 Completed - Clinical trials for Head and Neck Cancer

Risk for Subsequent Osteoradionecrosis in A Transferred Fibula Flap in Head and Neck Cancer Patients Undergoing Segmental Mandibulectomy: a Cohort Study

Start date: March 1, 2019
Phase:
Study type: Observational

A retrospective analysis of 329 patients at one single institution between January 2014 and December 2019 who underwent free fibula flap reconstruction was conducted. A variety of clinicopathological postoperative parameters were identified and assessed.

NCT ID: NCT06413888 Completed - Clinical trials for Delayed Gastric Emptying

Nasogastric Decompression Following Pancreaticoduodenectomy

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Start date: June 1, 2018
Phase: N/A
Study type: Interventional

Pancreaticoduodenectomy (PD) remains the gold-standard operation for peri-ampullary neoplasms. Traditionally, gastric decompression via nasogastric intubation has been employed postoperatively to prevent nausea, vomiting, aspiration pneumonia, anastomotic leakage and delayed gastric emptying. Recently, the implementation of ERAS protocol recommended against routine use of nasogastric tube following PD. however, limited data exists surrounding the identification of those patients needing NGT decompression in the immediate postoperative period. Therefore, we initiated a large prospective randomized controlled trial to evaluate the clinical outcomes of patients who retained the NGT post-PD versus those who had it removed at the end of the procedure. This study aims to assess the effectiveness of nasogastric decompression in PD recovery, with the primary endo point being the need for and impact of NGT in the postoperative recovery. The secondary endpoint will examined the re-insertion rate of NGT and identify factors that necessitate its use in the immediate postoperative period.

NCT ID: NCT06372886 Completed - Clinical trials for Pancreatic Head Cancer Patients Who Underwent Surgery After Neoadjuvant Treatment

Clinical Outcomes of Preservation Versus Resection of Portal/Superior Mesenteric Vein During Pancreaticoduodenectomy in Pancreatic Cancer Patients Who Respond to Neoadjuvant Treatment

Start date: January 1, 2012
Phase:
Study type: Observational

1. There is a lack of evidence on the need to perform portal/superior mesenteric vein (PV/SMV) resection routinely in pancreatic ductal adenocarcinoma (PDAC) patients with venous involvement who responded to neoadjuvant treatment (NAT). 2. There is no significant differences in R0 rate, 5-year overall survival and recurrence-free survival between the PV/SMV preservation (PVP) group and PV/SMV resection (PVR) group. 3. PVP group showed significantly better 5-year PV/SMV stenosis free survival than the PVR group. 4. We propose that if dissection is possible and there is a high likelihood of achieving R0 resection after NAT, routine PVR may be unnecessary in PDAC patients with venous involvement.

NCT ID: NCT06371365 Completed - Surgical Flaps Clinical Trials

Adverse Events for Free Flap Surgery in Head and Neck Cancer

Start date: October 19, 2022
Phase:
Study type: Observational

This is a cohort study collecting patients with head and neck cancer who underwent free flap surgery at a single medical center between January 2019 and January 2022.

NCT ID: NCT06318221 Completed - Clinical trials for Head and Neck Cancer

Effects of Perioperative Immunonutrition in Patients With Head and Neck Cancer

Start date: May 1, 2019
Phase: N/A
Study type: Interventional

A prospective randomized controlled study compared the effects of perioperative immunonutrition and standard enteral nutrition (EN) on postoperative short-term outcomes of patients with head and neck (HNC). Five days before surgery and the postoperative day 10, immunonutrition support was given to the intervention group (n=17), and standard EN support was given to the control group (n=17). Body analyses were made, food consumption records were taken, NRS-2002 and quality of life scales were applied, and biochemical parameters were recorded.

NCT ID: NCT06274905 Completed - Clinical trials for Head and Neck Cancer

Topical Anaesthesia in Cutaneous Head and Neck Surgery

Start date: February 20, 2023
Phase: N/A
Study type: Interventional

This study aims to assess if EMLA or ethyl chloride spray are effective in reducing the pain associated with local anaesthetic administration in cutaneous surgery of the head and neck compared to a placebo and control group through a randomized control trial study design.

NCT ID: NCT06171464 Completed - Clinical trials for Head and Neck Cancer

Prognostic Value of Pre-therapy 18F-FDG PET/CT for the Outcome of 18 FDG PET-guided SIB-IMRT in Patients With Head and Neck Cancer

Start date: February 21, 2013
Phase:
Study type: Observational

Head and neck cancer is the fifth most common cancer and represents 5% in the world. Selecting patients for the most appropriate treatment remains difficult. Approximately 60-65% of patients undergo surgery followed or not by radiotherapy. Patients with early stage disease (I-II) are treated with one treatment modality (surgery or radiotherapy), while patients with more advanced stage disease (III-IV) receive multimodal treatment (surgery together with associated radiotherapy or less to chemotherapy). PET/CT plays a fundamental role in the management of head and neck cancer patients. This investigation is indicated for staging, especially in patients with disease in advanced stages, for evaluating the response to therapy and for looking for recurrences as it is more accurate in distinguishing scar tissue from neoplasm. The objective of this retrospective study is to evaluate the prognostic value of PET/CT in predicting the outcome of patients undergoing SlB-IMRT/intensity modulated radiotherapy). The study proposed here involves the retrospective recruitment of patients who have performed a PET/CT investigation with 18F-FDG (fluorodeoxyglucose) at the U.O. of HSR Nuclear Medicine in the staging and treatment planning phase, between 2005 and 2011. The inclusion condition of the patients was their PET/CT evaluation (planning and treatment) using the "DSTE" PET/CT system installed at the U.O. of Nuclear Medicine HSR on which, in the presence of homogeneous lesions. a particular correction technique is applicable, developed and validated previously by the research group, which allows possible metabolic markers to be extracted from the lesions in a quantitatively accurate way.

NCT ID: NCT06152055 Completed - Clinical trials for Head and Neck Cancer

Clinicopathological Profile of Head and Neck Cancers in Army Hospital of Nepal

Start date: May 1, 2022
Phase:
Study type: Observational

This is a observational study conducted at the department of Ear ,Nose and Throat -Head and Neck Surgery (ENT-HNS) of Shree Birendra Hospital ,a tertiary health care centre of Nepal. Head and Neck cancers are the sixth most common cancer in the world. Data was collected from the medical records of Head and Neck Cancer patients who underwent treatment between May 2022 to April 2023.The main aim of the study was to know about the common cancers of head and neck region and their distribution according to the site. Also to know the stage of the presentation with treatment modalities in the tertiary health care centre of Nepal.