Clinical Research Directory

Head and Neck Cancer Strategies

The overall aim is to investigate whether genetic and other molecular markers can improve the diagnosis, assessment of treatment response, and detection of recurrence in patients with head and neck cancer. In the longer term, the project aims to contribute to more individualised treatment strategies for our patients. The project will involve comprehensive analyses of tumour tissue and blood, including extensive genetic sequencing and other molecular profiling. Importantly, the research analyses will not have any implications for the clinical management or treatment of the individual patient included in the study.

Oral Care Program for Mouth Side Effects During Head and Neck Radiation Therapy

People having radiation therapy to the head and neck often develop painful mouth problems - mouth sores, dry mouth, mouth pain, trouble eating and drinking, and changes in taste. These problems can become severe enough to interrupt radiation treatment or lead to an emergency room visit or a hospital stay. This study is testing whether an oral care program called OSEM (Oral Side-Effect Management) reduces how severe those mouth problems become. Fifty adults starting radiation to a head and neck site at Premier Cancer Center will take part. Each person will be assigned by chance, like a coin toss, to one of two groups: One group receives the Peace of Mouth Kit - everyday mouth care products including dry mouth candies, ginger candies for nausea, a mouth rinse, a sensitivity toothpaste, a soft toothbrush and a lip balm - together with a short check-in each week with a member of the Premier team right after their radiation treatment. The other group receives their usual care at Premier, unchanged. Everyone in the study fills out the same short questionnaire about their mouth each week during radiation, and once more about four weeks after their last treatment. Everyone continues to see their radiation doctor every week, exactly as they would if they were not in the study. Taking part lasts about 11 weeks in all. The items in the kit are everyday consumer mouth care products. They are not medicines of any kind, and the U.S. Food and Drug Administration has not approved them to treat or prevent any disease.

Swallowing Rehabilitation Program for Head and Neck Tumor Patients

This study aims to evaluate the effect of a structured swallowing rehabilitation program on swallowing function, trismus severity, and pain among patients with head and neck tumors, using a randomized controlled trial design. Eighty patients will be randomly allocated into two equal groups: a study group receiving the swallowing rehabilitation program and a control group receiving standard care.

Speed of Processing Training to Improve Cognitive Functioning and Driving Performance in Head and Neck Cancer Survivors

The goal of the study is to understand how well cognitive training improves reaction time in people with head and neck cancer (HNC). Aim 1. Evaluate the preliminary clinical effectiveness of a 10-week home- and video game-based SOPT on cognitive functioning and driving performance in HNC survivors. This study will include completing five questionnaires and simulated driving in a simulator at two different times, 10 weeks of participating in 2 sessions per week of video-game cognitive training at home and being interviewed once at the end of the 10-week training.

Screening Psychosocial Distress in Head and Neck Cancer

This prospective, multicenter study aims to assess the presence of psychosocial distress using the Distress Thermometer in patients treated for head and neck cancer at the initiation of their speech-language therapy. It also seeks to evaluate the evolution of this distress over a two-month period, as well as its correlation with patient engagement in therapy, functional disorders, and overall quality of life (assessed using the EORTC QLQ-C30 and QLQ-HN35 questionnaires). By capturing longitudinal changes in distress levels, functional impairments, and patient commitment to therapy, this research seeks to clarify the SLP's role in comprehensive supportive oncology care and optimize timely psychological referrals for vulnerable patients. The study hypothesizes that a significant proportion of patients experience clinically meaningful psychosocial distress (score ≥ 4 on the Distress Thermometer) at the start of speech-language therapy. It is also expected that this distress correlates with lower therapeutic engagement and impaired quality of life, and that early screening by speech-language pathologists will improve the timely referral of patients to psychological support professionals.

Online Perioperative Education Program on Patient Satisfaction and Clinical Outcomes for Head and Neck Surgery

CareOrbit is a digital perioperative patient-education and care navigation platform developed by the St. Louis-based venture Total Orbit in collaboration with Washington University's CORTEX Business Incubator. For head and neck cancer (HNC) care, the platform is designed to address gaps in perioperative education by guiding patients through each stage of their surgical journey using structured modules, step-by-step instructional videos, and centralized educational resources. CareOrbit delivers physician-authored content tailored to an individual's surgical care, including overviews of surgical treatment, preoperative preparation, and expectations for postoperative recovery. Early anecdotal experiences suggest that patients appreciate the accessibility of the tool, but systematic evaluation is lacking in whether use of the tool improves understanding, satisfaction, and care outcomes. This project will address key knowledge gaps by employing a clinical trial to examine key clinical endpoints.

Comparing Intraoperative Indocyanine Green Fluorescence Imaging With Standard Clinical Assessment for Flap Perfusion in Head and Neck Reconstruction (VISION Trial)

This is a prospective multicentre randomised controlled trial evaluating whether intraoperative indocyanine green (ICG) fluorescence angiography improves outcomes in head and neck free flap reconstruction compared with standard clinical assessment of flap perfusion. Adult patients undergoing microvascular free flap reconstruction for oncologic, trauma, or benign head and neck defects will be randomised to either intraoperative ICG angiography or conventional clinical perfusion assessment. The primary outcome is partial flap loss requiring intervention within 30 days after surgery. Secondary outcomes include total flap loss, flap-related re-exploration, flap salvage, and postoperative complications.

Evaluating Avive+ Soft Tissue Matrix for Prevention of Superficial Radial Nerve Morbidity Following Radial Forearm Free Flap Harvest

Radial forearm free flap (RFFF) reconstruction is commonly used for head and neck defects but is associated with donor-site morbidity, including neuropathic pain and sensory disturbance. This randomized controlled pilot study evaluates whether placement of a soft tissue matrix over the superficial radial nerve at the donor site reduces neuropathic pain and improves sensory outcomes compared to standard closure alone.

Immunomonitoring of Circulating Immune Cells in Maxillofacial Surgery

The immune response following facial reconstruction may help predict healing time and the date of discharge after maxillofacial surgery. Regulatory T cells (Tregs) are emerging as powerful modulators of the immune response in various contexts during reconstruction. Indeed, Tregs are involved in tissue regeneration, control the local inflammatory response, and promote effective tissue repair while limiting fibrosis. An early increase in circulating Tregs could serve as an indicator of a favorable reparative/regenerative response. Primary objective: To identify changes in the proportion of regulatory T cells (Tregs) among circulating immune cells between the preoperative and postoperative periods, and to assess its association with length of hospital stay. Primary outcome measure: proportion of regulatory T cells (Tregs) among CD4 lymphocytes, measured by flow cytometry at different time points (preoperative, perioperative, and postoperative), and its association with length of hospital stay (days). Study Design: monocentric, including a maximum of 60 patients; Inclusion criteria: Age ≥ 18 years; managed in the department of maxillofacial surgery (Pitié-Salpêtrière Hospital); Scheduled for surgery as part of treatment involving free flap reconstruction; Informed about the study, with no objections, and having provided written consent for genetic testing Exclusion criteria: Pregnant or breastfeeding women; Individuals under legal protective measures Research Process: After verifying eligibility criteria, patients will be informed about the study during a clinical visit. Following a reflection period that the patient deems necessary to make a decision, their lack of objection and consent to genetic testing will be obtained. As part of the research, a 7 mL tube of ACD blood will be collected in addition to the routine blood samples during routine blood draws at the following visits: preoperative, perioperative (during surgery), and postoperative follow-ups (Day 2, Day 5, and Day 15). These tubes will then be analyzed in the Immunology Research Laboratory of Prof. Miyara and Dr. Bouaoud (CIMI, Pitié Salpêtrière) using flow cytometry (counting/assay of Tregs and subpopulations). During the operation, surgical waste (bone, muscle, drainage fluids) will also be collected for research purposes; it will be analyzed in the immunology research laboratory of Prof. Miyara and Dr. Bouaoud (CIMI, Pitié Salpêtrière) using flow cytometry and, in some cases, single-cell transcriptomics when the sample meets the necessary quality criteria (sufficient cell count, viability, etc.).

A Study to Assess Safety, Tolerability and Imaging Characteristics of [68Ga]Ga-DPI-4452 and to Assess Safety, Tolerability, and Efficacy of [177Lu]Lu-DPI-4452 in Participants With Unresectable Locally Advanced or Metastatic Solid Tumors

The main purpose of Part A of the study is to evaluate safety, tolerability and tracer uptake after a single intravenous (IV) administration of \[68Ga\]Ga-DPI-4452 for each tumor type such as clear cell renal cell cancer (ccRCC), pancreatic ductal adenocarcinoma (PDAC), and colorectal cancer (CRC); Part B: is to determine the recommended phase 2 dose (RP2D) \[maximum tolerated dose (MTD) or lower dose\] for \[177Lu\]Lu-DPI-4452 for each tumor type such as ccRCC, PDAC, CRC, and urothelial carcinoma (UC); Part C: is to evaluate the preliminary antitumor activity of \[177Lu\]Lu-DPI-4452 as monotherapy for each tumor type such as ccRCC, PDAC, CRC, and UC; Part D: is to assess the diagnostic concordance between \[68Ga\]Ga-DPI-4452 Positron Emission Tomography (PET) and the histopathology result of the Indeterminate Renal Mass (IDRM); Part E: is to assess \[68Ga\]Ga-DPI-4452 uptake in each tumour type such as UC, muscle invasive bladder cancer (MIBC), head and neck cancer (H\&N), triple negative breast cancer (TNBC), squamous non-small cell lung cancer (NSCLC), and any other tumor with locally confirmed carbonic anhydrase (CA) IX expression except ccRCC, CRC and PDAC.

PET-CT Imaging With PCD-CT

This pilot study evaluates the clinical utility of photon counting detector computed tomography (PCD-CT) in PET-CT imaging for head and neck cancer. Twenty adult patients undergoing standard-of-care PET-CT will also receive PCD-CT imaging. The study compares image quality and diagnostic confidence between conventional energy-integrating detector CT (EID-CT) and PCD-CT for attenuation correction and anatomical imaging.

FAPI PET Imaging - An Exploratory Study

This study is testing a new imaging tracer called \[18F\]FAPI-74 with PET scans. Researchers want to find out how well this tracer shows certain diseases in the body, including several types of cancer and some non-cancer conditions like fibrosis and sarcoidosis. \[18F\]FAPI-74 attaches to a protein found on cells that are active in tumors and areas of scarring or inflammation. This may help doctors see these areas more clearly than with imaging methods used today, especially in diseases where current scans do not work well. People who join this study will get one injection of the tracer into a vein, then have one PET/CT or PET/MR scan. This takes about 2 hours in total. Researchers will compare the results with imaging the participant already had as part of their regular care, such as other PET scans, CT, or MRI. No extra treatment is given, and no other visits are needed. The study will take place at 5 hospitals in Switzerland and plans to include about 770 adults with a confirmed or suspected diagnosis of one of the conditions being studied. The main goal is to see how clearly the tracer shows up on the scan. Researchers will also look at whether this new scan changes how confident doctors feel about a diagnosis, or changes the patient's treatment plan.

Effects of Far Infrared Rays and Transcutaneous Electrical Nerve Stimulation on Short Term Prognosis of Head and Neck Cancer Patients Receiving Curative Treatment

This clinical trial aims to evaluate whether far infrared radiation therapy and transcutaneous electrical nerve stimulation can reduce treatment-related side effects in patients with head and neck cancer undergoing concurrent chemoradiotherapy. The primary objectives of this study are to determine whether far infrared radiation therapy and transcutaneous electrical nerve stimulation can improve shoulder pain and disability, cervical range of motion, maximum interincisal distance, oral mucositis, systemic inflammation, and chemotherapy-induced nausea and vomiting. Participants will be randomly assigned to one of three groups: Group A will receive standard care (control group); Group B will receive standard care plus transcutaneous electrical nerve stimulation; and Group C will receive standard care plus far infrared radiation therapy combined with transcutaneous electrical nerve stimulation. The intervention will be administered over two cycles of concurrent chemoradiotherapy, for a total of 10 intervention days. During each treatment cycle, participants in the intervention groups will receive the assigned treatment once every morning and once every evening for five consecutive days. Outcome assessments will be performed at three time points during each treatment cycle: before the intervention on Day 1 (baseline), after the intervention on Day 3, and after the intervention on Day 5.

Oral, Fecal and Intratumoral Microbiome Atlas in Colombian Patients With Advanced Solid Tumors Receiving First-Line Immunotherapy

This is a prospective observational cohort study conducted at Fundación CTIC in Bogotá, Colombia. It characterizes the oral, fecal and intratumoral microbiome of Colombian adults with advanced solid tumors (gastric, colorectal, breast, cervical and head-and-neck cancer) who receive first-line immunotherapy as standard of care, and compares them with healthy volunteers. Using multi-omics (HiFi metagenomics, 16S, tumor RNA-Seq and untargeted metabolomics), the study aims to identify microbial signatures associated with treatment response and survival, building the initial Colombian cohort of a Cancer Microbiome Atlas with Latin American projection.

Observational Basket Trial to Collect Tissue to Develop and Train a Live Tumor Diagnostic Platform (ELEPHAS-02)

The primary objective of this study is to develop and train the Elephas live tumor diagnostic platform and determine the ex-vivo accuracy of the Elephas Score using in-vivo RECIST 1.1 as the reference method

Prophylactic Intervention for Dysgeusia in Head and Neck Cancer Patients Following Radio(Chemo)Therapy

Taste changes, also called dysgeusia, affect 56-76% of patients with head and neck cancer treated with radiotherapy (with or without chemotherapy). These taste changes can make eating difficult, lead to weight loss, and reduce quality of life. Despite how common and impactful this problem is, there are very few standardized tools in speech-language therapy to assess or prevent it. The aim of this study is to develop and test a preventive rehabilitation program for taste function. Eighty patients will be divided into two groups. The experimental group will receive a specific speech-language therapy intervention focused on taste for four weeks. This intervention includes: salivary gland massage to stimulate saliva production, internal cryotherapy to keep the mouth moist and improve sensitivity, and taste training using four basic tastes at different intensity levels. The effects of the intervention will be assessed before radiotherapy (with or without chemotherapy), at the end of treatment, and then 1, 3, 6 months, and 2 years after treatment. Assessment will include clinical tests, saliva measurements, taste detection and recognition tests, and quality-of-life questionnaires. This clinical intervention aims to detect taste changes early and prevent them, helping to improve patients' comfort and nutrition.

Evaluation of [⁶⁸Ga/¹⁷⁷Lu]HT547: Safety, Biodistribution, and Dosimetry in Solid Tumors

Urokinase plasminogen activator receptor (uPAR), the cell-surface receptor for its ligand uPA, plays a critical role in regulating cell migration and invasion-key drivers of cancer progression. This study aims to evaluate a novel uPAR-targeting radiopharmaceutical pair: the diagnostic agent \[⁶⁸Ga\]Ga-HT547 and the therapeutic agent \[¹⁷⁷Lu\]Lu-HT547. In patients with breast cancer, head and neck cancer, pancreatic cancer, or glioma, we will assess the diagnostic performance and biodistribution of these tracers using \[⁶⁸Ga\]Ga-HT547 and \[¹⁷⁷Lu\]Lu-HT547 SPECT/CT.

AI-Assisted Endoscopy for Upper Aerodigestive Tract Lesions

This is a prospective observational clinical study designed to evaluate the performance of artificial intelligence (AI) algorithms applied to upper aerodigestive tract (UADT) video-endoscopy. The study assesses three main tasks: lesion detection (localization), classification (benign vs malignant), and segmentation of tumor margins. AI algorithms will be applied to endoscopic video data acquired during routine clinical practice without influencing clinical decision-making. The system will process images in real time and store data for subsequent analysis. AI outputs will be compared with physician assessment and reference standard histopathology to evaluate diagnostic performance.

Effectiveness of 0.9% Normal Saline Soaking in Managing Acute Radiation Dermatitis

The goal of this clinical trial is to learn if normal saline soaks can reduce the severity of acute radiation dermatitis in patients with sarcomas or head and neck cancer receiving radiotherapy. It will also learn if saline soaks can improve wound healing and reduce treatment interruptions caused by skin toxicity. The main questions it aims to answer are: 1. Does the application of normal saline soaks reduce the severity of acute radiation dermatitis according to CTCAE Version 5.0? 2. Does the use of normal saline soaks improve wound healing time and reduce the frequency and duration of radiotherapy interruptions? Researchers will compare standard care plus saline soaks (intervention group) to standard care alone (control group) to see if saline soaks reduce skin reaction severity and improve clinical outcomes. Participants will: 1. Be randomly assigned to receive either standard care alone or standard care with daily saline soaks 2. Apply saline-soaked gauze to the affected radiation area for 5-10 minutes once daily (intervention group only) 3. Attend weekly clinic visits for skin assessment during radiotherapy 4. Be assessed for skin reaction severity, wound healing, and treatment interruptions at baseline, after 4 weeks, and 2 weeks after completing treatment

eHealth Support Tool to Improve Quality of Life in Head and Neck Cancer Survivors

This study evaluates the development, implementation and effectiveness of a nurse-led eHealth support tool designed to improve quality of life and survivorship outcomes among adults treated for head and neck cancer. The intervention integrates symptom monitoring, self-management education, and structured survivorship support into routine follow-up care. Outcomes will include patient-reported quality of life, symptom burden, and healthcare utilization.

Oral Herpesviruses and Oral Mucositis in Patients Receiving Head and Neck Radiotherapy

Patients receiving radiotherapy for head and neck cancer often develop oral mucositis, a painful condition that causes redness and sores in the mouth. Oral mucositis can make it difficult to eat, drink, and speak, and may interfere with cancer treatment. Some viruses from the herpesvirus family, which commonly remain inactive in the body, may become active during cancer treatment and worsen mouth sores. However, the role of these viruses in oral mucositis is not fully understood. This study aims to understand whether herpesviruses present in the mouth are associated with the development and severity of oral mucositis in adults receiving radiotherapy for head and neck cancer. The study also evaluates whether taking an antiviral medication (valacyclovir) can reduce viral activity and improve mouth symptoms during treatment. Participants are randomly assigned to receive either valacyclovir or a placebo while undergoing radiotherapy. Samples from the mouth and saliva are collected at different time points before, during, and after radiotherapy to detect herpesviruses. Mouth sores are regularly examined, and pain levels are recorded throughout treatment. The results of this study may help clarify the role of herpesviruses in oral mucositis and support better strategies to prevent or manage this condition in patients receiving radiotherapy for head and neck cancer.

Access to Care Pilot for ED-Presenting Head and Neck Cancer Patients (ENRICH-HNC)

Patients diagnosed with head and neck cancer (HNC) after presenting to an emergency department (ED) often face significant delays in diagnosis and treatment. These patients are frequently younger, underinsured, and experience multiple socioeconomic and systems-level barriers to accessing timely cancer care. Delays of more than 30 days have been associated with worse outcomes, including higher recurrence rates and reduced survival. This pilot study will evaluate the feasibility and early impact of a community-based navigation program designed to improve access to timely care for ED-presenting HNC patients. The study embeds trained Community Health Support Specialists (CHSS) from the Engaging Navigators to Reduce Inequities in Cancer Health (ENRICH) program into the ED-to-treatment pathway. After ED discharge, CHSS staff will contact participants by telephone or text message to identify barriers to care-such as transportation, insurance, housing, or communication challenges-and connect them with appropriate community or institutional resources. All participants will receive the CHSS navigation intervention. Outcomes will be compared with a historical cohort of similar ED-presenting HNC patients treated prior to program implementation. The primary outcomes are time from ED discharge to diagnostic biopsy and time from ED discharge to initiation of definitive treatment. Secondary outcomes include feasibility, measured as the proportion of participants who complete CHSS navigation, and exploratory analyses of the types of barriers identified and resolved. Findings from this pilot will generate preliminary data to inform larger studies aimed at improving access, reducing disparities, and accelerating treatment for head and neck cancer patients who first present in the emergency setting.

Effects of Far Infrared Rays and Transcutaneous Electrical Nerve Stimulation on Short Term Prognosis of Head and Neck Cancer Patients Receiving Curative Treatment

The goal of this clinical trial is to determine whether far-infrared therapy and transcutaneous electrical nerve stimulation (TENS) can improve postoperative side effects in patients with head and neck cancer. The main questions this study aims to answer are: Can far-infrared therapy and transcutaneous electrical nerve stimulation reduce pain and improve neck range of motion? Can far-infrared therapy and transcutaneous electrical nerve stimulation reduce inflammation? Researchers will compare three groups: Group A: control group; Group B: transcutaneous electrical nerve stimulation; Group C: far-infrared therapy combined with transcutaneous electrical nerve stimulation, to evaluate differences in pain, neck range of motion, and inflammation. Participants will receive the assigned intervention in the morning and evening for five consecutive days. Outcome measurements will be conducted on the first and fifth days.