Clinical Research Directory

Real-time Molecular Diagnosis of Oral Precancer

The "Real-time molecular diagnosis of oral precancer" or the LIP study is testing a new device for the detection of cancer in the mouth. Oral cancers are serious and devastating illnesses, especially if detected at a late stage. Currently, the detection of oral cancer relies on testing a biopsy, which involves cutting a small section of tissue from the mouth and sending it to the pathology laboratory for further testing. A doctor or dentist taking the biopsy must rely on their own eyesight and experience to spot areas of concern. It can therefore be difficult to detect the earliest stages of cancer. At times, cancer tissue is only detected because it has already developed, and this affects the success of the treatment. The device tested in this study uses a laser beam to scan areas inside the mouth and a computer collects information about the scan. The goal of this project is to train the computer software in the device to recognize pre-cancer and cancer from normal scans. Patients who need to have a biopsy due to suspected pre-cancer or cancer in the mouth will be scanned with the device. Biopsy reports will be used to tell the software which scans were from pre-cancer or cancer or non-cancer tissues. Volunteers with healthy oral tissue will be included to further test the computer software. Secondary aims include collecting pilot safety data and feedback regarding the use of this device. If successful, the results from this pilot study will lead to a bigger trial to further study how the device can be used for cancer diagnosis.

Tongue Proactive Strengthening Exercise Program Following Partial/Hemi Glossectomy and Reconstruction

This study is being done to determine whether adding a proactive tongue strengthening exercise program using a biofeedback device (the Tongueometer) improves speech and swallowing outcomes after surgery for tongue cancer. Patients who undergo partial or hemiglossectomy often experience difficulties with speech and swallowing, which can significantly impact their quality of life. While speech and swallow therapy is typically provided in response to problems, this study investigates whether introducing structured tongue strengthening exercises with biofeedback early-can lead to better long-term outcomes. This research will help establish whether this approach should become part of standard post-operative care.

Antibiotic Treatment Effects on Intratumoral Bacteria Modulation in Surgical Patients With Oral Cancer

The goal of this phase II single arm clinical study is to evaluate the effect of antibiotics (metronidazole) and oral chlorhexidine (CHX) in reducing the bacteria load within tumors of patients undergoing surgery for oral cancer.

Defining Mechanisms of Surgical Site Infection After Oral Cancer Surgery

The study design is an observational cohort study of patients undergoing standard of care oral cavity reconstruction. An observational study is required to prospectively evaluate microbial and antibiotic mechanisms underlying surgical site infection after oral cavity reconstruction.

Validation of ICG-99mTc-nanoscan as Hybrid Tracer for Sentinel Node Biopsy

99mTc-nanocolloid, the world wide used hybrid tracer for dynamic sentinel node biopsy, has recently been replaced with 99mTc-nanoscan. The hybrid form (ICG-99mTc-nanoscan) has not yet been validated, to show the similarity between the lymphatic drainage pattern between ICG-99mTc-nanoscan and 99mTc-nanoscan.

Morphological Changes of Upper Trapezius Muscle After Physotherapy in Oral Cancer

The study aims to evaluate the morphological changes of upper trapezius muscle, using B-mode ultrasonography, in patients with oral cancer undergone neck dissection and physiotherapy. It also investigates the relationship between morphological changes and shoulder active range of motion in abduction. Furthermore , the study assesses the potential of B-mode ultrasonography as an objective tool for monitoring outcomes of the rehabilitation in this population.

A Feasibility Study of AI-Assisted Physiotherapy for Oral Cancer Patients

This study aims to evaluate the feasibility, safety, and acceptability of a newly developed artificial intelligence (AI)-assisted physiotherapy system for oromandibular and neck-shoulder range of motion (ROM) in patients who have undergone treatment for oral cancer. In this single-group, prospective, non-randomized pilot study, recruited participants will receive 4 to 6 weeks of AI-assisted physiotherapy. Participants will undergo a comprehensive clinical evaluation at baseline and post-intervention. During the intervention period, the AI system will perform a daily automated assessment to dynamically generate and adjust personalized exercise programs. Participants will perform these prescribed programs 3 to 4 times daily. Pre- and post-intervention changes, along with key feasibility parameters, acceptability, and safety metrics, will be statistically analyzed to inform future definitive trials.

Novel Tracheostomy Tube Fixation Device in Oral Cancer Patients

This study evaluated a novel tracheostomy tube fixation device in post-tracheostomy patients with oral cancer. After tracheostomy, conventional fixation methods may be associated with skin pressure injury, wound contamination, frequent dressing changes, tube displacement, and patient discomfort. The novel fixation device was designed to provide stable tube fixation, protect the cervical skin, facilitate wound care, and improve patient comfort. A total of 150 eligible patients who underwent tracheostomy were randomly assigned to a treatment group or a control group. Patients in the control group received routine tracheostomy care and conventional fixation. Patients in the treatment group received the novel self-adhesive bidirectional tracheostomy tube fixation device in addition to routine tracheostomy care. The study assessed whether the novel fixation device could reduce tracheostomy-related complications, improve nursing efficiency, reduce the frequency and duration of wound care, improve neck comfort, and maintain safe tracheostomy tube fixation.

Effectiveness and Impact of the Lived Experience Cancer Awareness Campaign on Screening Participation

This study will be conducted as a parallel-arm, open-label, randomized controlled trial (RCT) to evaluate the effectiveness and impact of the Lived Experience Communication Campaign (LECC) on cancer screening participation rates \[oral, breast and cervical cancer\] compared to the usual standard awareness campaign across selected rural population in Villupuram district, Tamil Nadu.

Durvalumab With Radiotherapy for Adjuvant Treatment of Intermediate Risk SCCHN

The purpose of this study is to investigate other drugs that may be combined with radiation to treat cancer. The study focuses on determining whether a combination of durvalumab with radiation can both improve cure rate and at the same time have less serious side effects. Throughout this document, this investigational drug will be referred to as the "study drug", or named individually (durvalumab). The study drug in this research is referred to as investigational because the U.S. Food and Drug Administration (FDA) has not yet approved itfor the treatment of head and neck cancer. Durvalumab was FDA approved in 2017 for the treatment of certain types of bladder cancer, but has not been approved for use in Head and Neck cancer patients. Durvalumab is an experimental drug that uses the body's immune system to fight the cancer. This study drug is being used in other ongoing clinical trials for other types of cancers. The doctor feels that a patient may experience fewer side effects using this study drug with radiation rather than using cisplatin. The doctor is also investigating whether using this drug can increase the effectiveness of treatment.

Exploratory Study of Inhaled Afatinib Dimaleate PK Profile

This is a pilot Phase I open-label randomized single-dose two-period crossover study (in the EDDIS project) evaluating the bioequivalence, pharmacokinetics (PK), safety, and tolerability of inhaled afatinib dimaleate compared with the reference oral afatinib dimaleate in healthy volunteer smokers. The study will enroll healthy adult volunteers smoker to assess the systemic exposure and lung deposition of inhaled afatinib dimaleate. Participants will receive both the test inhaled formulation and the reference oral formulation in separate periods with delayed phase between treatments. Key endpoints include maximum plasma concentration (Cmax), area under the concentration-time curve (AUC), and lung deposition assessed via bronchoalveolar lavage (BAL), frequency of occurrence of side effects and cases of toxicity during the studies

Mandibular Reconstruction Preplanning (ViPMR)

Virtual Surgical Planning (VSP), where 3D modeling is used to create 3D-printed surgical guides, has been shown to improve outcomes for patients who undergo mandibular reconstruction surgery, usually due to invasion of cancer from the oral cavity to the jaw. This trial will directly compare the outcomes of patients who receive VSP versus patients who receive the current standard of care, which is Free-Hand Surgery (FHS). They will be randomized into either treatment at a 1:1 ratio and bony union rates will be compared between 12-month postoperative CT scans for each treatment group. Secondary objectives include comparing other short and long-term complication rates, reconstruction accuracy, quality of life, and functional outcomes of VSP and FHS. An economic analysis of VSP will also be performed.

Relationship Between Mouth Opening and Masseter Elasticity in Oral Cancer

The study aims to assess the hardness of masticatory muscles in post-surgical oral cancer patients using strain elastography ultrasound, calculating the masseter elasticity index and exploring its association with maximum interincisal mouth opening. Furthermore, the study incorporates exercise training to analyze whether changes in masseter hardness can serve as an objective indicator for predicting the improvement of trismus.

Brodalumab in the Treatment of Immune-Related Adverse Events

The purpose of this study is to test the safety and effectiveness of using brodalumab in patients who develop side effects from cancer immune therapy. Immune-related side effects are due to activation of the immune system in patients who previously received immunotherapy and the goal of this study is to help better control these side effects. Brodalumab is often used to treat patients with autoimmune diseases (diseases where the immune system is activated against normal organs) and safe doses and treatment schedules have been determined in these patients. Immune-related side effects appear to closely mirror these autoimmune conditions. Brodalumab has not been approved by the United States Food and Drug Administration (FDA) for use in immunotherapy side effects but it has been approved for treatment of autoimmune conditions.

Surgeon-performed Ultrasound for Real-time Guidance In Oral Cancer Surgeries - A Multicenter Randomized Controlled Trial

The goal of this clinical trial is to improve the surgical treatment of patients with oral cancer. We will explore whether the use of surgeon performed ultrasound during these surgeries result in better tumor removal. We hypothesize that using intraoperative ultrasound to assist the resection results in more frequent clear surgical margins in oral cancer surgeries compared to standard methods. This improvement is associated with a reduced need for post-operative adjuvant therapies such as radiotherapy and reoperation, lower mortality rates, lower cancer recurrence, and enhanced quality of life for patients undergoing surgery for oral cancer. Participants will be randomized to either the control or intervention group: * Control group will receive standard treatment for oral cancer. * Intervention group will in addition to the standard treatment have surgery performed using ultrasound to guide the resection and evaluate resection margins intraoperatively. Outcomes: * Number of free surgical margins between control and intervention group. * Intraoperative surgeon assessed surgical margins compared to final histology report. * Dysphagia and quality of life questionnaires. * Recurrence rates. * Mortality rates. All participant will be followed-up at 3 months and 12 months with: * MDADI dysphagia questionnaire * EORTC head and neck cancer quality of life questionnaire * Follow-up on recurrrence and mortality.

Prosthesis Guided Speech Rehabilitation of T1/T2 Cancers of the Tongue

This study will fill a scientific gap in the current knowledge providing data for evaluation of the palatal augmentation prosthesis (PAP) as a therapeutic modality post-surgery. This is a robust scientific randomized prospective clinical trial. Positive outcomes from this study have the potential to dramatically alter the most common issues of oral cancer therapy, namely speech and swallowing functions. Patients will have been diagnosed with a cancer lesion of the tongue requiring surgery and removal of part of the tongue. Smaller cancers of the tongue are sized as T1 or T2. For patients with smaller lesions, a PAP, which can aid in speaking and swallowing, is not routinely provided.

Enhancing Oral Cancer Awareness

To evaluate the impact of AI-powered chatbot interactions versus traditional educational handouts on increasing participants' knowledge of oral cancer and its prevention

Clinical and Molecular Features of Oral Premalignancy and Oral Cancer

Investigators will employ serial assessments of tissue biopsy and additional biomarkers that reflect burden of disease and predict treatment response. Patients enrolled on this study will be given the option to provide biological samples before, during, and after treatment, as well as functional outcomes of treatment response. These samples will be utilized to develop and validate prognostic and predictive biomarkers for patients undergoing targeted therapy, immunotherapy, surgery, chemotherapy, and/or radiotherapy.

Evaluation of Two Non-Invasive Methods, High-Resolution Microendoscopy and Liquid-Based Cytology, for Detection of Oral Precancer

Cancers of the oral cavity (lip, oral tongue, gingivae, floor of mouth, hard palate, and other mouth tissues including buccal mucosa) are amongst the most common worldwide, with an estimated annual burden of over 300,000 incident cases. Most oral cancers (\>75%) are attributable to cigarette smoking, alcohol drinking, and chewing of areca nut/betel quid with or without tobacco, and very few are related to human papillomavirus infection. Oral cancer incidence geographically tracks with the prevalence of these risk factors and is notably high in the Indian subcontinent (due to tobacco chewing and smoking) and southeast Asia (due to betel quid chewing without tobacco and smoking). The current standard for screening for oral precancer/cancer is visual and tactile examination by an expert for the presence of clinical/visual lesions (leukoplakia, erythroplakia, and oral submucous fibrosis). Such visually identified lesions are further triaged based on clinical impression for a biopsy to determine histopathologic presence/grade of dysplasia. Several observations point to key limitations of oral cancer screening based on clinical impression-based biopsy of visually identified lesions, including the decision to biopsy a lesion, which lesion to biopsy, and where within the lesion to direct a biopsy. Thus, there is a need for tools for improved triage of visual precancers for biopsy and targeting areas for biopsy within a lesion for more effective risk stratification and better provision of care. Two non-invasive methods hold promise for triage of lesions for biopsy-oral liquid-based cytology and high-resolution microendoscopy (HRME). Oral cytology provides a method to non-invasively sample visible oral lesions and holds promise to enable triage of lesions for biopsy. HRME utilizes optical fiber-based imaging in combination with the fluorescent contrast agent proflavine to image sub-cellular features in vivo in lesions/epithelial tissues, functionally an in situ biopsy. The investigators propose to conduct a cross-sectional study to evaluate the clinical utility of these two non-invasive methods for detecting oral precancer and early oral cavity cancer- the performance of oral cytology and HRME as an adjunct for triage of visible lesions for biopsy and the performance of HRME as an adjunct to enable better within-lesion targeting of areas for biopsy. If successful, this study would facilitate the development of a non-invasive, 3-step algorithm for oral cancer screening: identification of lesions through visual inspection, triage for biopsy through cytology or HRME, and targeted within-lesion biopsy (if needed) through HRME.

AI-based Physiotherapy Evaluation System for Range of Motion in Oral Cancer Patients

This study aims to evaluate the validity and reliability of a novel AI-based physiotherapy evaluation system for measuring oromandibular and neck-shoulder range of motion (ROM). Traditional ROM assessments rely on manual measurements, which may be influenced by rater experience and variability. The proposed AI system uses automated keypoint tracking to provide objective and standardized measurements. In this cross-sectional study, healthy adult participants will perform standardized ROM tasks. Measurements obtained from the AI system will be compared with those from two independent raters using conventional clinical tools. Repeated measurements will be conducted to assess intra-rater and inter-rater reliability. The agreement between the AI system and human raters will be evaluated to determine the system's clinical applicability.

AI-based Physiotherapy for Oral Cancer Patients

This study examines the effects of AI-based physiotherapy on oral function, shoulder function, whole-body physical function, and quality of life in oral cancer patients. One hundred patients will be recruited before surgery, chemotherapy, or radiotherapy and randomly assigned to an experimental group receiving 12 weeks of AI-guided physiotherapy or a control group receiving usual care. Both groups will perform jaw, neck, and shoulder exercises, with the experimental group using a mobile app to monitor progress. Assessments at baseline, pre-intervention, and 3 months post-intervention will measure maximal in the maximum interincisal opening (MIO), joint range of motion (ROM), pain, endurance (e.g., 6-minute walk test), upper extremity function, and quality of life.

Resection and Defect Repair of Oral Cancer Aided by Mixed Reality Technology

The objective of this exploratory clinical trial is to apply Unreal Engine 5 (UE5)-based Mixed Reality (MR) technology to achieve real-time stereoscopic visualization of surgical planning, personalized free flap harvest and defect reconstruction, accurate oral cancer resection, and precise morphological and volumetric matching of the reconstructed free flap to the defect site. Researchers adopted a parallel controlled design, with participants randomized into three groups: Experimental Group 1 (undergoing Mixed Reality \[MR\] technology-assisted surgery), Experimental Group 2 (undergoing virtual surgical guide-assisted surgery), and Control Group (undergoing conventional surgery). A total of 30 participants will be recruited, with 10 cases in each group. The primary purpose is to confirm the effectiveness of MR technology in assisting oral cancer resection, free flap design, harvest, and defect reconstruction. Allocation concealment will be implemented via the sealed envelope method.

Low-cost Screening and Image-guided Photodynamic Therapy (PDT) of Premalignant and Malignant Oral Lesions

The primary goal of this study is to see if photodynamic therapy (PDT) is effective for treatment of lesions in the oral cavity which have high risk of becoming oral cancer. PDT treatment uses a drug, called a photosensitizer, which makes the diseased cells become light-sensitive such that they are destroyed when laser light is delivered to the target lesion. In this study a new handheld device, called SITOS (a "Screen, Image and Treat Optical System), is used. The ability of this device to simultaneously visualize the inside of the mouth and deliver laser light to the target site will be evaluated. The main questions this study seeks to answer are: * Can this treatment completely cure oral potentially malignant lesions (OPML) without need for surgery? * Do lesions recur after PDT treatment? * Is the SITOS device easy to use for the doctor and comfortable for the patient, both as an oral imaging device and as a treatment device?

Microbiome in Head and Neck Squamous Cell Carcinoma

This study aims to determine whether dysbiosis actively contributes to HNSCC and if so, the underlying molecular mechanisms.