Treatment Trials

258 Clinical Trials for Various Conditions

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NOT_YET_RECRUITING
Methotrexate, Erlotinib, and Celecoxib for the Treatment of Recurrent/Metastatic Oral Cavity Cancer in a Rural Midwest United States Population
Description

This phase II trial gathers information on the feasibility, safety, and effect of giving methotrexate, erlotinib, and celecoxib in treating oral cavity cancer that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic) among rural Midwest patients. Methotrexate is in a class of medications called antimetabolites. It is also a type of antifolate. Methotrexate stops cells from using folic acid to make deoxyribonucleic acid and may kill tumor cells. Erlotinib is in a class of medications called kinase inhibitors. It works by blocking the action of a protein called EGFR that signals tumor cells to multiply. This helps slow or stop the spread of tumor cells. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving the combination of methotrexate, erlotinib, and celecoxib may be feasible, safe, and effective in treating rural Midwest patients with recurrent/metastatic oral cavity cancer.

NOT_YET_RECRUITING
Enhancing Oral Cancer Awareness Among Minorities
Description

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

RECRUITING
Defining Mechanisms of Surgical Site Infection After Oral Cancer Surgery
Description

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.

Conditions
RECRUITING
The Efficacy of Conventional Screening Versus mHealth Screening in Early Detection of Oral Potentially Malignant Disorders and Oral Cancer Amongst the Rural Population of Varanasi: A Prospective and Blinded Study
Description

Mobile health (mHealth) will be used for early detection of oral cancer and pre-cancer lesions, and to improve awareness of oral cancer among the population and knowledge of oral cancer diagnosis among frontline health providers. This program is inclusive of long term surveillance to downstage oral cancer in India

RECRUITING
Role of Acetaldehyde in the Development of Oral Cancer
Description

This is a minimal risk intervention study where healthy volunteers and individuals with Fanconi anemia will consume a single dose of alcohol and provide primarily non-invasive biological samples at various time points. Biospecimens to be collected include saliva, oral cells collected via mouthwash and cheek brush, and urine. The collection of two blood samples (5 mL each) will be optional and banked for future use.

TERMINATED
Metformin for the Prevention of Oral Cancer in Patients With Oral Premalignant Lesions
Description

This phase I trial tests whether metformin works in reducing the annual transformation (development of invasive cancer) of oral precancerous lesions into cancerous lesions. Metformin is a drug approved for the treatment of diabetes, but studies have shown that it may have some anticancer properties. Giving metformin may help prevent or slow the development of oral cancer from precancerous lesions.

SUSPENDED
Comparing Sentinel Lymph Node (SLN) Biopsy With Standard Neck Dissection for Patients With Early-Stage Oral Cavity Cancer
Description

This phase II/III trial studies how well sentinel lymph node biopsy works and compares sentinel lymph node biopsy surgery to standard neck dissection as part of the treatment for early-stage oral cavity cancer. Sentinel lymph node biopsy surgery is a procedure that removes a smaller number of lymph nodes from your neck because it uses an imaging agent to see which lymph nodes are most likely to have cancer. Standard neck dissection, such as elective neck dissection, removes many of the lymph nodes in your neck. Using sentinel lymph node biopsy surgery may work better in treating patients with early-stage oral cavity cancer compared to standard elective neck dissection.

WITHDRAWN
Nivolumab & IRX-2 With Surgery for Resectable Stage III-IVA Oral Cavity Cancer or HPV-Positive Oropharyngeal Cancer
Description

This phase I trial studies the side effects of nivolumab and IRX-2 and how well they work in treating participants with stage III-IVA oral cavity cancer or human papillomavirus (HPV)-positive oropharyngeal cancer that can be removed by surgery. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. IRX-2 may "turn on" the immune system and stimulate an immune response against tumor cells. Giving nivolumab and IRX-2 followed by surgery may work better at treating oral cavity and oropharyngeal cancer.

COMPLETED
Pharmacokinetic (PK) Analysis of Antitumor B in Patients With Oral Cancer
Description

A Window of Opportunity Clinical Trial. This study design permits examination of effects of an oral agent on cancer patients during the "window" between diagnosis of their cancer and their definitive cancer surgery. Similar to a phase 0 study, the trial design permits examination of the biologic effects of an agent; in this study pharmacokinetic properties will be examined.

TERMINATED
Photodynamic Therapy With HPPH Compared to Standard of Care Surgery in Treating Patients With Oral Cavity Cancer
Description

This randomized phase II clinical trial studies how well photodynamic therapy with HPPH works compared to standard of care surgery in treating patients with oral cavity cancer. Photodynamic therapy can destroy or control disease by using a combination of drug, such as HPPH, and light and may be as effective as surgery in treating patients with oral cavity cancer.

COMPLETED
Trial of Nivolumab as a Novel Neoadjuvant Pre-Surgical Therapy for Locally Advanced Oral Cavity Cancer
Description

The purpose of this study is to look at the effectiveness of nivolumab in patients with oral cavity cancer (OCC) who are about to undergo surgery.

Conditions
COMPLETED
Non Invasive Oral Cancer Screening Among HIV Infected Individuals
Description

The goal of this clinical research study is to learn how a new method for performing oral (mouth) exams can help doctors check for suspicious lesions (called premalignant and malignant oral lesions \[PMOL\]) in the mouth of HIV-infected smokers.

ACTIVE_NOT_RECRUITING
Metformin Hydrochloride in Preventing Oral Cancer in Patients With an Oral Premalignant Lesion
Description

This phase IIa trial studies how well metformin hydrochloride works in preventing oral cancer in patients with an oral premalignant lesion (oral leukoplakia or erythroplakia). Oral premalignant lesions look like red or whitish plaques or lesions in the mouth that do not rub off and can be associated with a higher risk of cancer. Metformin hydrochloride may help prevent oral cancer from forming in patients with an oral premalignant lesion.

RECRUITING
Reflectance Confocal Microscopy of Oral Cancers in Vivo: a Preliminary Trial Comparing Intra-oral Imaging With Pathology
Description

The purpose of this study is to get images (pictures) of oral lesions, which occur inside the mouth, before the patient's surgery using a special camera. These pictures will be used in our research to evaluate a new technology that uses a laser and takes pictures of the microscopic structure of tissue. The technology is called "reflectance confocal microscopy." We would like to compare what the camera sees to biopsies (pathology) of the same area. We will evaluate the pictures obtained from the patient to determine whether this technology may be useful in the future. We hope this technology can be used as a tool for early diagnosis of oral cancers and for guiding surgery.

COMPLETED
Establishing Lymphedema and Fibrosis Measures in Oral Cancer Patients
Description

This four-year, prospective, longitudinal study will evaluate and validate a patient-reported outcome measure, clinician-reported outcome measures, and imaging techniques in assessing characteristics, trajectory, and progression of lymphedema and fibrosis (LEF) in oral cavity and oropharyngeal cancer patients. This clinical trial studies patient-and-clinician-reported measures as well as standard imaging methods to see how accurate they are in identifying and evaluating lymphedema (swelling) or fibrosis (tough or tight tissue) in the head and neck region of patients receiving treatment for newly diagnosed stage II-IV oral cavity or oropharyngeal cancer. Lymphedema and fibrosis (LEF) can lead to physical symptoms, such as trouble swallowing and chewing, as well as psychological and emotional symptoms, such as negative body image and avoiding social interactions. Finding an accurate test to identify and evaluate LEF may allow doctors to treat LEF more quickly and control symptoms more effectively, and thus provide patients with a better quality of life.

COMPLETED
Direct Visual Fluorescence in Finding Oral Cancer in High-Risk Patients and Patients Undergoing Routine Dental Care
Description

This clinical trial studies direct visual fluorescence in finding oral cancer in high-risk patients and patients undergoing routine dental care. Diagnostic procedures, such as direct visual fluorescence, may help find and diagnose oral cancer.

COMPLETED
Freeze-Dried Black Raspberries in Preventing Oral Cancer Recurrence in High At-Risk Appalachian Patients Oral Cancer Survivors
Description

This pilot clinical trial studies freeze-dried black raspberries (BRB) in preventing oral cancer recurrence in high at-risk Appalachian patients previously treated with surgery for oral cancer. Chemoprevention is the use of drugs natural products to keep cancer from developing, progressing, or recurring. Giving freeze-dried black raspberries may prevent oral cancer from forming or returning in oral cancer survivors.

COMPLETED
Phase 1b Food Based Modulation of Biomarkers in Human Tissues at High-Risk for Oral Cancer.
Description

This randomized phase I/II trial studies the side effects and best way to give lyophilized black raspberries in preventing oral cancer in high-risk patients previously diagnosed with stage I-IV or in situ head and neck cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of lyophilized black raspberries may prevent oral cancer. Studying samples of oral cavity scrapings, blood, urine, and saliva in the laboratory from patients receiving lyophilized black raspberries may help doctors learn more about changes that occur in DNA and the effect of lyophilized back raspberries on biomarkers.

Conditions
Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell CarcinomaSalivary Gland Squamous Cell CarcinomaStage 0 Hypopharyngeal CancerStage 0 Laryngeal CancerStage 0 Lip and Oral Cavity CancerStage 0 Nasopharyngeal CancerStage 0 Oropharyngeal CancerStage 0 Paranasal Sinus and Nasal Cavity CancerStage I Salivary Gland CancerStage I Squamous Cell Carcinoma of the HypopharynxStage I Squamous Cell Carcinoma of the LarynxStage I Squamous Cell Carcinoma of the Lip and Oral CavityStage I Squamous Cell Carcinoma of the NasopharynxStage I Squamous Cell Carcinoma of the OropharynxStage I Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityStage I Verrucous Carcinoma of the LarynxStage I Verrucous Carcinoma of the Oral CavityStage II Salivary Gland CancerStage II Squamous Cell Carcinoma of the HypopharynxStage II Squamous Cell Carcinoma of the LarynxStage II Squamous Cell Carcinoma of the Lip and Oral CavityStage II Squamous Cell Carcinoma of the NasopharynxStage II Squamous Cell Carcinoma of the OropharynxStage II Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityStage II Verrucous Carcinoma of the LarynxStage II Verrucous Carcinoma of the Oral CavityStage III Salivary Gland CancerStage III Squamous Cell Carcinoma of the HypopharynxStage III Squamous Cell Carcinoma of the LarynxStage III Squamous Cell Carcinoma of the Lip and Oral CavityStage III Squamous Cell Carcinoma of the NasopharynxStage III Squamous Cell Carcinoma of the OropharynxStage III Verrucous Carcinoma of the LarynxStage III Verrucous Carcinoma of the Oral CavityStage IV Squamous Cell Carcinoma of the HypopharynxStage IV Squamous Cell Carcinoma of the NasopharynxStage IVA Salivary Gland CancerStage IVA Squamous Cell Carcinoma of the LarynxStage IVA Oral Cavity Squamous Cell CarcinomaStage IVA Squamous Cell Carcinoma of the OropharynxStage IVA Nasal Cavity and Paranasal Sinus CancerStage IVA Verrucous Carcinoma of the LarynxStage IVA Verrucous Carcinoma of the Oral CavityStage IVB Salivary Gland CancerStage IVB Squamous Cell Carcinoma of the LarynxStage IVB Squamous Cell Carcinoma of the Lip and Oral CavityStage IVB Squamous Cell Carcinoma of the OropharynxStage IVB Oral Cavity Squamous Cell CarcinomaStage IVB Verrucous Carcinoma of the LarynxStage IVB Verrucous Carcinoma of the Oral CavityStage IVC Salivary Gland CancerStage IVC Squamous Cell Carcinoma of the LarynxStage IVC Oral Cavity Squamous Cell CarcinomaStage IVC Squamous Cell Carcinoma of the OropharynxParanasal Sinus and Nasal Cavity Squamous Cell CarcinomaStage IVC Verrucous Carcinoma of the LarynxStage IVC Verrucous Carcinoma of the Oral CavityTongue Cancer
WITHDRAWN
Biomarkers in Tissue Samples From Patients Who Have Undergone Neck Dissection for Oral Cancer
Description

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research study is looking at tissue samples in predicting oral cancer in patients who have undergone neck dissection for oral cancer.

TERMINATED
EF5 to Evaluate Tumor Hypoxia in Patients With High-Grade Soft Tissue Sarcoma or Mouth Cancer
Description

This laboratory study is using EF5 to evaluate tumor hypoxia in patients with high-grade soft tissue sarcoma or mouth cancer. Using the drug EF5 to measure the oxygen level in tumor cells may help in planning cancer treatment

COMPLETED
Contact Allergies to Dental Metal as a Possible Risk Factor for Oral Cancer
Description

RATIONALE: Gathering information about allergies to metals may help doctors learn whether having an allergy to metal used in dental work increases the risk of developing oral cancer. PURPOSE: This clinical trial is studying contact allergies to dental metal as a possible risk factor for oral cancer.

TERMINATED
Photodynamic Therapy Using HPPH in Treating Patients With Recurrent Dysplasia, Carcinoma in Situ, or Stage I Oral Cavity Cancer
Description

RATIONALE: Photodynamic therapy uses a drug, such as HPPH, that is absorbed by tumor cells. The drug becomes active when it is exposed to light. When the drug is active, tumor cells are killed. PURPOSE: This phase I trial is studying the side effects and best dose of photodynamic therapy using HPPH in treating patients with recurrent dysplasia, carcinoma in situ, or stage I oral cavity cancer.

ACTIVE_NOT_RECRUITING
Widefield Fluorescence and Reflectance Imaging Systems and Oral Tissue Samples in Monitoring Participants at Risk for Developing Oral Cancer
Description

This clinical trial studies widefield fluorescence and reflectance imaging, fluorescence spectroscopy, and tissue samples in regularly examining (monitoring) participants at risk for developing oral cancer. All tissue and cells are made of tiny particles. Some of these particles give off small amounts of light. This light is called fluorescence. Fluorescent imaging use instruments that shine different wavelengths (colors) of light in the mouth taking fluorescence pictures through a portable head light or by taking fluorescent and reflectance pictures through a dental microscope using a digital camera. Fluorescent spectroscopy uses a small probe placed gently against the lining of the mouth and the tissue is exposed to small amounts of fluorescent light that is then collected with a special camera and a computer to be analyzed. Checking mouth tissue samples under a microscope may also help detect abnormal cells. Diagnostic procedures, such as fluorescence and reflectance imaging, fluorescence spectroscopy imaging, and tissue samples, may help doctors detect pre-cancer or early cancer when it may be easier to treat.

TERMINATED
Photodynamic Therapy Using Porfimer Sodium in Treating Patients With Recurrent Mouth or Throat Dysplasia or Recurrent In Situ Cancer or Stage I Cancer of the Mouth or Throat
Description

RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. Photodynamic therapy using porfimer sodium may be effective against mouth or throat dysplasia and cancer of the mouth and throat. PURPOSE: This phase I trial is studying how well photodynamic therapy using porfimer sodium works in treating patients with recurrent mouth or throat dysplasia, recurrent in situ cancer of the mouth or throat, or stage I cancer of the mouth or throat.

COMPLETED
Oral Cancer Screening Among Nursing Home Dentists in Ohio
Description

RATIONALE: Learning about oral cancer screening practices, knowledge, and opinions of Ohio nursing home dentists may help the study of oral cancer in the future. PURPOSE: This clinical trial is studying oral cancer screening among nursing home dentists in Ohio.

COMPLETED
Smoking Status and Body Image in Oral Cancer Patients
Description

Primary Objectives: 1. To characterize smoking behaviors and body image in patients with oral cavity cancer prior to and following surgical procedures. 2. To examine the relationship between smoking status and body image in this sample of head and neck cancer patients. 3. To examine the influence of smoking status and body image on quality of life outcomes.

TERMINATED
S0011, Gene Therapy & Surgery Followed by Chemo & RT in Newly Diagnosed Cancer of the Mouth or Throat
Description

RATIONALE: Inserting the p53 gene into a person's cancer cells may improve the body's ability to fight cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy and radiation therapy with the p53 gene may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of gene therapy plus surgery followed by cisplatin and radiation therapy in treating patients who have newly diagnosed resectable stage III or stage IV cancer of the mouth or throat.

COMPLETED
Lymphoscintigraphy to Detect Early Metastases in Patients With Cancer of the Mouth or Throat
Description

RATIONALE: New imaging procedures such as lymphoscintigraphy may improve the ability to detect the spread of mouth and throat cancer to lymph nodes in the neck. PURPOSE: Pilot study of lymphoscintigraphy followed by sentinel lymph node mapping and sentinel lymph node biopsy to detect lymph node metastases in the neck in patients who have mouth or throat cancer.

TERMINATED
S9908: Glutamine in Treating Mucositis Caused by Radiation Therapy in Patients With Newly Diagnosed Cancer of the Mouth or Throat
Description

RATIONALE: Glutamine may be effective in decreasing side effects, such as inflammation of the mouth and throat, caused by radiation therapy. The effectiveness of glutamine for mucositis is not yet known. PURPOSE: Randomized phase III trial to determine the effectiveness of glutamine in treating patients who develop mucositis following radiation therapy for newly diagnosed cancer of the mouth or throat.

COMPLETED
Dentures and Dental Implants in Treating Patients Undergoing Surgery for Mouth Cancer
Description

RATIONALE: The use of dentures and dental implants may help maintain chewing and speaking ability following surgery to remove tumors in the mouth. PURPOSE: Phase II trial to study the effectiveness of dentures and dental implants in maintaining the ability to chew and speak in patients undergoing surgery for mouth cancer.