Oral Cancer

About Oral Cancer Clinical Trials (Click to Open)

Join Clinical Trials for Oral Cancer

General Purpose:

Oral cancer is often described collectively with other cancers that occur in the head and neck as simply “head and neck cancer.” However, literally speaking, cancers that arise in the mouth can affect the lips, tongue, cheek lining, floor of the mouth, gums, or palate (roof of the mouth).

Unfortunately, the majority of oral cancers spread quickly and therefore require immediate treatment. Most are also linked to the use of alcohol and tobacco; however, additional risk factors include chronic irritation from things such as dentures or fillings, human papillomavirus (HPV) infection, the use of immunosuppressant medications, and poor oral hygiene practices.

The good news is that if detected early before they have spread, oral cancers have nearly a 90% cure rate; the bad news is that over half of all oral cancers have usually spread by the time the cancer is diagnosed. As such, approximately 25% of patients die as a result of delayed diagnosis and treatment.

For those reasons, researchers are hard at work to identify new and improved methods of screening and diagnosis for oral cancer among high-risk patients, as well as refining existing treatments and developing new ones with the intent of improving treatment-related outcomes and life expectancy.

In addition, a considerable amount of research is underway to develop strategies that more effectively minimize and prevent the numerous complications associated with treatment for oral cancer (including those associated with radiation therapy, disfigurement, and quality of life concerns). 

What Will Oral Cancer Clinical Trials Be Like? 

Clinical trials for oral cancer may involve many common tests and procedures; however, the ultimate design of the particular study will determine which specific procedures you will undergo. Examples of specific tests and procedures that may be used in a clinical trial for oral cancer include the following:

  • Physical exam and detailed history of tobacco and alcohol use.
  • Blood and/or tissue sample to test for the presence of HPV infection.
  • Blood and/or tissue sample for the purposes of conducting genetic testing.
  • If the study is evaluating a new type of medication or vaccine, blood and/or urine tests may be performed to monitor how your body metabolizes the medication or how effectively your body has responded to the vaccine.
  • Detailed examination of the mouth and tongue.
  • Imaging procedures such as computed tomography (CT scan, or “CAT scan”) or magnetic resonance imaging (MRI) scans. These imaging procedures are non-invasive and provide detailed pictures of areas inside your body. Conventional x-rays may also be used.
  • Surgery
  • Biopsy
  • Quality of life assessments to evaluate how your cancer is impacting your ability to perform activities of daily living.
  • Pain assessments.
  • Dietary assessments.

Typical Oral Cancer Clinical Trial Protocol:

Examples of sample clinical trials in oral cancer might include the following:

  • A clinical trial to determine if patients’ HPV status has an impact on their survival following treatment for oral cancer.
  • A clinical trial to determine if an innovative dosing schedule for radiation therapy is more effective at treating lip cancer than a conventional dosing schedule for radiation therapy.
  • A study to determine if the use of a salivation-boosting drug is effective at decreasing the rate of dry mouth in tongue cancer patients following radiation therapy, compared to the rate of dry mouth among tongue cancer patients who receive radiation therapy in addition to a placebo.
  • A study to determine if treatment with a newly developed drug is effective at reducing the incidence of oral cancer among individuals with high-risk pre-cancerous mouth lesions.
  • A long-term clinical trial to determine if specific dietary supplements or medications are effective at reducing the risk of oral cancer in high-risk individuals who smoke and drink alcohol. 

A brief word about randomized trials and placebos:

Many clinical trials involve the comparison of an investigational treatment to a “standard” treatment. Some studies determine which therapy a patient receives through a process known as randomization, in which patients are randomly assigned to receive either the investigational treatment or the standard treatment.

On occasion, a trial will investigate the use of a standard treatment plus a new drug compared to standard treatment plus a placebo (such as the third clinical trial example provided above). Placebos are inactive or “sham” treatments that are identical in appearance to the active treatment but have no therapeutic value.

Placebos are necessary to help determine if adverse effects that occur during the clinical trial are the result of the investigational treatment or due to some other factor. They also allow researchers to measure the effects of the active treatment and observe what would have happened without it.

In rare instances where no standard therapy exists, or when a new drug is being evaluated for the first time in a specific cancer, the investigational treatment might be compared to a placebo alone. In these types of trials, those patients who are randomized to the placebo group do not receive an active treatment.

This is rarely done in cancer clinical trials; however, it may occasionally be necessary from a scientific standpoint. Placebo-only trials will only be done when ethically appropriate and when patients have been adequately informed that they may end up receiving the placebo rather than the active treatment.

It is very important to note, however, that no one should ever participate in such a placebo trial when there is a widely available and highly effective standard treatment already in existence for their particular type of cancer and clinical situation.

Trial Eligibility and Medical Information Needed:

The type of clinical trial you may be eligible for often depends on many factors, including your disease stage, treatment history, and a variety of clinical findings. Therefore, it is important to know many details pertaining to your specific diagnosis when searching for clinical trials. Examples of the details you will want to have on hand include: 

  • The name, location, size, stage, and cell type of your cancer, as well as the locations of any metastases you have. Also know these details for any prior cancer you have had.
  • Know your performance status, which estimates how well you perform normal activities of daily living. Examples: Karnofsky Performance Scale (KPS) and the ECOG scale.
  • Know your treatment history, including chemotherapy, radiation therapy, immunotherapy, and/or surgery.
  • Know your blood cell counts, liver function test results, and kidney function test results.

 Suggested Search Terms: 

The following search terms may be useful when added to the keywords “oral cancer”:  “prevention,” “treatment,” “surgery,” “chemotherapy,” “radiation therapy,” “treatment side effects,” “HPV,” “human papillomavirus,” “nutrition,” “pain,” “quality of life,” “screening,” “smoking,” and “alcohol.”



Current Search Term:

“Oral Cancer”

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Submandibular Gland Preservation in Neck Dissection

Conditions:   Neck Dislocation;   Oral Cancer
Interventions:   Procedure: modified neck dissection;   Procedure: traditional neck dissection
Sponsors:   Guang-Yan Yu;   Jia-Zeng Su
Active, not recruiting

The Oral Microbiome and Upper Aerodigestive Squamous Cell Cancer

Condition:   Oral Cancer
Interventions:   Other: Classification of Oral Microbiome Using 16S rRNA gene sequence-based approach;   Other: Classification of Oral Microbiome Using taxonomic approach
Sponsors:   New York University School of Medicine;   National Institutes of Health (NIH)

Rehabilitation Outcomes in Head and Neck Survivors

Conditions:   Head and Neck Cancer;   Oral Cancer
Intervention:   Other: Physiotherapy
Sponsor:   Chang Gung Memorial Hospital

Innovative Approach to Triage Oral Precancer

Conditions:   Oral Cancer;   Oral Premalignant Lesion
Sponsors:   British Columbia Cancer Agency;   BC Cancer Foundation;   University of British Columbia

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

Condition:   Oral Cavity SCC
Intervention:   Drug: Nivolumab
Sponsors:   David Neskey;   Bristol-Myers Squibb

Participatory Research for Fine-tuning of a 2.0 System to Optimise Home Management of Oral Cancer Therapies.

Conditions:   Cancer;   Oral Drug Administration
Intervention:   Device: TreC-Onco
Sponsors:   Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori;   Kessler Foundation

Non Invasive Oral Cancer Screening Among HIV Infected Individuals

Conditions:   Malignant Neoplasms of Mesothelial and Soft Tissue;   Human Immunodeficiency Virus
Interventions:   Behavioral: Screening Interview;   Device: Carbon Monoxide Test;   Behavioral: Self-Help Materials;   Procedure: Visual Oral Screening Examination;   Procedure: Direct Fluorescent Oral Visualization Examination;   Procedure: Oral Biopsy
Sponsors:   M.D. Anderson Cancer Center;   Baylor College of Medicine;   The University of Texas Health Science Center, Houston

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

Conditions:   Erythroplakia;   Hyperplasia;   Mild Dysplasia;   Moderate Dysplasia;   Oral Cavity Carcinoma;   Oral Leukoplakia;   Severe Dysplasia
Interventions:   Other: Laboratory Biomarker Analysis;   Drug: Metformin Hydrochloride
Sponsor:   National Cancer Institute (NCI)
Active, not recruiting

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

Conditions:   Head and Neck Cancer;   Squamous Cell Carcinoma (SCC) of the Oral Cavity
Intervention:   Device: Reflectance Confocal Microscopy
Sponsor:   Memorial Sloan Kettering Cancer Center

Sentinel Lymph Node Mapping of Oral Cancer Using Near-Infrared Fluorescence Imaging

Condition:   Head and Neck Neoplasms
Interventions:   Procedure: Sentinel lymph node mapping;   Drug: Indocyanine Green (ICG);   Device: near-infrared fluorescence (NIR) imaging (Pinpoint, Novadaq, Waterloo)
Sponsor:   University Health Network, Toronto

Establishing Lymphedema and Fibrosis Measures in Oral Cancer Patients

Conditions:   Oral Cavity Cancer;   Oropharyngeal Cancer;   Lymphedema;   Fibrosis
Interventions:   Other: LEF measures;   Procedure: Technical measure
Sponsors:   Vanderbilt-Ingram Cancer Center;   National Cancer Institute (NCI);   National Institute of Dental and Craniofacial Research (NIDCR)

Diagnostic Aids for Detection and Diagnosis of Oral Cancer

Condition:   Head and Neck Cancer
Interventions:   Behavioral: Questionnaire;   Device: POS + PS2 + VELscope;   Procedure: Oral Brush Biopsy
Sponsors:   M.D. Anderson Cancer Center;   National Institutes of Health (NIH);   William Marsh Rice University

Analysis Of Sensory Recovery Of Donor Size And Quality Life In Oral Cancer Patients

Condition:   Oral Cancer
Sponsor:   Kaohsiung Medical University Chung-Ho Memorial Hospital

Improving Adherence to Oral Cancer Agents and Self Care of Symptoms Using an IVR

Conditions:   Prostatic Neoplasms;   Breast Neoplasms;   Colorectal Neoplasms;   Melanoma;   Leukemia
Intervention:   Behavioral: Interactive Voice Response (IVR) Reminders
Sponsors:   Michigan State University;   National Cancer Institute (NCI)

Validation of DNA Methylation Biomarkers for Oral Cancer Detection

Condition:   Oral Cancer
Sponsor:   National Taiwan University Hospital

Autofluorescence Detection of Oral Malignancies and Database and Biospecimen Collection to Identify Biomarkers of Head and Neck Tumor Progression

Condition:   Oral Cancer
Sponsor:   Roswell Park Cancer Institute
Active, not recruiting

Freeze-Dried Black Raspberries in Preventing Oral Cancer Recurrence in High-Risk Appalachian Patients Previously Treated With Surgery For Oral Cancer

Conditions:   Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity;   Stage I Squamous Cell Carcinoma of the Oropharynx;   Stage I Verrucous Carcinoma of the Oral Cavity;   Stage II Squamous Cell Carcinoma of the Lip and Oral Cavity;   Stage II Squamous Cell Carcinoma of the Oropharynx;   Stage II Verrucous Carcinoma of the Oral Cavity;   Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity;   Stage III Squamous Cell Carcinoma of the Oropharynx;   Stage III Verrucous Carcinoma of the Oral Cavity;   Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity;   Stage IVA Squamous Cell Carcinoma of the Oropharynx;   Stage IVA Verrucous Carcinoma of the Oral Cavity;   Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity;   Stage IVB Squamous Cell Carcinoma of the Oropharynx;   Stage IVB Verrucous Carcinoma of the Oral Cavity;   Stage IVC Squamous Cell Carcinoma of the Lip and Oral Cavity;   Stage IVC Squamous Cell Carcinoma of the Oropharynx;   Stage IVC Verrucous Carcinoma of the Oral Cavity;   Tongue Cancer
Interventions:   Drug: lyophilized black raspberry lozenge;   Other: survey administration;   Other: laboratory biomarker analysis;   Other: pharmacological study
Sponsor:   Ohio State University Comprehensive Cancer Center

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

Conditions:   Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma;   Salivary Gland Squamous Cell Carcinoma;   Stage 0 Hypopharyngeal Cancer;   Stage 0 Laryngeal Cancer;   Stage 0 Lip and Oral Cavity Cancer;   Stage 0 Nasopharyngeal Cancer;   Stage 0 Oropharyngeal Cancer;   Stage 0 Paranasal Sinus and Nasal Cavity Cancer;   Stage I Salivary Gland Cancer;   Stage I Squamous Cell Carcinoma of the Hypopharynx;   Stage I Squamous Cell Carcinoma of the Larynx;   Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity;   Stage I Squamous Cell Carcinoma of the Nasopharynx;   Stage I Squamous Cell Carcinoma of the Oropharynx;   Stage I Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity;   Stage I Verrucous Carcinoma of the Larynx;   Stage I Verrucous Carcinoma of the Oral Cavity;   Stage II Salivary Gland Cancer;   Stage II Squamous Cell Carcinoma of the Hypopharynx;   Stage II Squamous Cell Carcinoma of the Larynx;   Stage II Squamous Cell Carcinoma of the Lip and Oral Cavity;   Stage II Squamous Cell Carcinoma of the Nasopharynx;   Stage II Squamous Cell Carcinoma of the Oropharynx;   Stage II Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity;   Stage II Verrucous Carcinoma of the Larynx;   Stage II Verrucous Carcinoma of the Oral Cavity;   Stage III Salivary Gland Cancer;   Stage III Squamous Cell Carcinoma of the Hypopharynx;   Stage III Squamous Cell Carcinoma of the Larynx;   Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity;   Stage III Squamous Cell Carcinoma of the Nasopharynx;   Stage III Squamous Cell Carcinoma of the Oropharynx;   Stage III Verrucous Carcinoma of the Larynx;   Stage III Verrucous Carcinoma of the Oral Cavity;   Stage IV Squamous Cell Carcinoma of the Hypopharynx;   Stage IV Squamous Cell Carcinoma of the Nasopharynx;   Stage IVA Salivary Gland Cancer;   Stage IVA Squamous Cell Carcinoma of the Larynx;   Stage IVA Oral Cavity Squamous Cell Carcinoma;   Stage IVA Squamous Cell Carcinoma of the Oropharynx;   Stage IVA Nasal Cavity and Paranasal Sinus Cancer;   Stage IVA Verrucous Carcinoma of the Larynx;   Stage IVA Verrucous Carcinoma of the Oral Cavity;   Stage IVB Salivary Gland Cancer;   Stage IVB Squamous Cell Carcinoma of the Larynx;   Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity;   Stage IVB Squamous Cell Carcinoma of the Oropharynx;   Stage IVB Oral Cavity Squamous Cell Carcinoma;   Stage IVB Verrucous Carcinoma of the Larynx;   Stage IVB Verrucous Carcinoma of the Oral Cavity;   Stage IVC Salivary Gland Cancer;   Stage IVC Squamous Cell Carcinoma of the Larynx;   Stage IVC Oral Cavity Squamous Cell Carcinoma;   Stage IVC Squamous Cell Carcinoma of the Oropharynx;   Paranasal Sinus and Nasal Cavity Squamous Cell Carcinoma;   Stage IVC Verrucous Carcinoma of the Larynx;   Stage IVC Verrucous Carcinoma of the Oral Cavity;   Tongue Cancer
Interventions:   Other: placebo;   Other: laboratory biomarker analysis;   Other: questionnaire administration;   Drug: chemoprevention
Sponsor:   Ohio State University Comprehensive Cancer Center

Fluorescence & Reflectance Imaging to Detect Oral Neoplasia

Condition:   Oral Cancer
Interventions:   Procedure: Portable Spectroscopy System;   Procedure: Multispectral Digital Microscope;   Procedure: Fast Excitation-Emission Matrix System
Sponsors:   M.D. Anderson Cancer Center;   National Institute of Dental and Craniofacial Research (NIDCR);   National Cancer Institute (NCI)

Spectroscopy for Diagnostic Assessment of Oral Mucosal Lesions

Condition:   Oral Cancer
Intervention:   Procedure: Fluorescence Spectroscopy
Sponsor:   M.D. Anderson Cancer Center

Oral Margin Spectroscopy Detection Using Optical Spectroscopy

Condition:   Oral Tumors
Interventions:   Device: FastEEM4 System;   Device: Multispectral Digital Microscope
Sponsors:   M.D. Anderson Cancer Center;   National Institute of Dental and Craniofacial Research (NIDCR);   National Institutes of Health (NIH)

Erlotinib Prevention of Oral Cancer (EPOC)

Condition:   Oral Cancer
Interventions:   Drug: Erlotinib;   Drug: Placebo
Sponsors:   M.D. Anderson Cancer Center;   National Cancer Institute (NCI);   Astellas Pharma US, Inc.
Active, not recruiting

Study of Induction Docetaxel, Cisplatin and 5-Fluorouracil

Conditions:   Squamous Cell Carcinoma;   Oral Cancer
Interventions:   Drug: Docetaxel;   Drug: Cisplatin;   Drug: 5-fluorouracil
Sponsors:   Emory University;   Sanofi

Biomarkers for Oral Cancer

Conditions:   Lichen Planus;   Oral Leukoplakia
Sponsors:   National Institute of Dental and Craniofacial Research (NIDCR);   National Cancer Institute (NCI)

Elective vs Therapeutic Neck Dissection in Treatment of Early Node Negative Squamous Carcinoma of Oral Cavity

Condition:   Oral Cancer
Interventions:   Procedure: Elective neck dissection in early oral cancer;   Procedure: Therapeutic Neck Dissection
Sponsor:   Tata Memorial Hospital
Active, not recruiting

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