Wounds and Injuries

All Conditions

Neoplasms

Symptoms and General Pathology

Mouth and Tooth Diseases

Digestive System Diseases

Infections

Head and Neck Neoplasms

Ulcer

Stomatitis

Mucositis

Gingivitis

Gingivitis, Necrotizing Ulcerative

Gastroenteritis

Gastrointestinal Diseases

Mouth Diseases

Stomatognathic Diseases

Communicable Diseases

Fusobacterium Infections

Bacterial Infections

Gram-Negative Bacterial Infections

Mycoses

Bacterial Infections and Mycoses

Gingival Diseases

Periodontal Diseases

Analgesics

All Drugs and Chemicals

The MuReva Phototherapy System consists of Light Control Unit and two Mouthpiece Cable Assemblies. Subjects will begin device treatment photobiomodulation sessions on the first day of radiotherapy (RT) treatment. They will receive once-daily investigative device photobiomodulation treatments prior to radiation therapy (RT) with their assigned Mouthpiece for 5 days per week for the duration of their CRT treatment. Each device treatment session will last up to 5 minutes, not including up to 5 additional minutes for treatment breaks. All subjects will visit the study site once during the Screening period (Days -28 to 1) and an anticipated 30 to 40 times during the treatment period. Each patient will be assigned their own Mouthpiece Cable Assembly set.

The MuReva Phototherapy System (or sham control) is a Light Control Unit and a set of Mouthpiece Cable Assemblies. The sham control Mouthpiece Cable Assemblies will appear identical to the active Mouthpiece Cable Assembly, and will be used in the same manner as the active cohort. However, the sham control device will be configured where the mouthpiece will not emit any light at any time during the study. The same Light Control Unit will be used with sham and active Mouthpiece Cable Assemblies. Each patient will be assigned their own Mouthpiece Cable Assembly set.

Provide photobiomodulation therapy to subjects prior to each radiation therapy session.

Photobiomodulation

Standard oral care, oral hygiene and oral pain protocols

Routine Oral Care and Analgesia

Nancy B Lipko, MD MBA

The overall purpose of this clinical study is to evaluate safety and efficacy of the MuReva Phototherapy System with a light delivery mouthpiece to reduce the severity of oral mucositis (OM) in adult patients with squamous cell carcinoma of the oral cavity, oropharynx, tonsils and base of tongue receiving radiation therapy with or without concurrent chemotherapy.

Study Design: A prospective, multi-center, randomized, double-blind, placebo controlled, adaptive sample size, two-treatment parallel, pivotal clinical study.

Protocol-eligible subjects will be randomized in a 1:1 allocation to receive either the active MuReva Phototherapy System or a sham control. Both the subjects and clinician evaluating the patients will be blinded to the treatment assignments. The sham device will be placed in the patient's mouth and operated in the same manner as the active device, but not deliver any therapy.

Subjects will begin device treatment sessions on the first day of radiation treatment (RT) and will continue to receive once daily treatments prior to RT with their assigned device for 5 days per week for the duration of their RT treatment (approximately 6 to 8 weeks, for a total of 30 to 40 device sessions depending on the standard of care regimen for the type of cancer). Each device treatment session will last approximately 10 minutes in total. Light therapy parameters for the MuReva Phototherapy System will be as follows for all subjects receiving active light therapy: 660nm, 2-12 J/cm2 nominal fluence. Subjects who stay on RT treatment past 6 weeks will continue to receive treatment with their assigned devices up through 8 total weeks of treatment (for a maximum total of 40 phototherapy sessions). In addition, all subjects, regardless of randomization, will be kept on standard oral care, oral hygiene and oral pain protocols.

All subjects will visit the study site once during the Screening period (Days -28 to 1) and an anticipated 30 to 40 times during the treatment period (i.e., 5 days during each of the 6-8 RT treatment weeks). Weekly, subjects will be evaluated for oral mucositis and for device safety. The weekly assessments will continue through the final RT session. A post-therapy assessment will be done approximately 2 weeks after completion of RT. At the conclusion of this assessment each subject's participation in the study will be complete.

A prospective, multi-center, randomized, double-blind, placebo controlled, adaptive sample size, two-treatment parallel, pivotal clinical study.

The sponsor, clinical research organization (CRO), subjects, research staff and Investigators performing the weekly OM evaluations for the study will be blinded to the treatment assignments. Subjects will be mandated to use light-blocking eyewear.

Only the research staff delivering treatment will be unblinded. No other personnel or visitors will be allowed in the treatment room during active/sham treatment.

The Investigators will not administer the daily treatment and will not visit or observe the patient during device use in order to remain blinded. The Investigators will also remain blinded to the patients' responses to the weekly Self-Assessments.

Photobiomodulation to Demonstrate Safety and Reduce the Incidence of Oral Mucositis in Adult Head & Neck Cancer Patients

Photobiomodulation Therapy Using the MuReva Phototherapy System to Demonstrate Safety and Reduce the Incidence of Oral Mucositis in Adult Patients With Head and Neck Cancer Receiving Radiation Therapy With or Without Concurrent Chemotherapy

A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify individual subjects. At most, the Web site will include a summary of the results after the study is completed. You can search this Web site at any time.

If the results of this study are published, individual subject identity will remain confidential.

Data, salivary fluid specimens and photographs collected in this research might be de-identified (name and any identifying information will be removed) and used for future research or distributed to another investigator for future research.

The primary effectiveness endpoint of the study is the severity of oral mucositis as assessed by the Oral Mucositis Index (OMI) score, on a scale of 0-60.

The proportion of patients who have severe oral mucositis (Grade 3 or 4) at week 6 of treatment according to the World Health Organization (WHO) Oral Toxicity Scale.

Oral Mucositis Weekly Questionnaire-Head and Neck Cancer

MuReva Phototherapy Inc.

Blood and Lymph Conditions

Immune System Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Lymphoma

Influenza, Human

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Respiratory Tract Infections

Orthomyxoviridae Infections

Virus Diseases

RNA Virus Infections

Respiratory Tract Diseases

Lymphosarcoma

B-cell Lymphoma

Vaccines

Group A: Trivalent subvirion vaccine - standard inactivated influenza vaccine by intramuscular injection.

Group B: Trivalent rHA0 vaccine 15 μg per rHA0 (total 45 μg rHA0)

Group C: Trivalent rHA0 vaccine 45 μg per rHA0 (total 135 μg rHA0)

Group D: Trivalent rHA0 vaccine 135 μg per rHA0 (total 405 μg rHA0)

Receive either standard inactivated influenza vaccine or one of three doses of the experimental vaccine, vaccine dose 15, 45 or 135 μg HA per virus, intramuscular injection.

Trivalent Baculovirus-expressed Influenza HA vaccine

Amar Safdar, MD

Primary Objective:

To assess the trend in immunogenic response across patients administered either licensed trivalent inactivated influenza vaccine (TIV) or one of three doses (15, 45 or 135 μg) of trivalent recombinant baculovirus expressed hemagglutinin vaccines. Immunogenic response is defined as a 4-fold or greater increase in serum antibody.

Secondary Objective:

To determine the safety and tolerability of 3 doses (15 μg HA per virus, 45 μg HA per virus, and 135 μg HA per virus) of recombinant baculovirus-expressed HA vaccine in patients with non-Hodgkin's B-cell lymphoma.

Influenza is a common respiratory infection caused by viruses. Standard influenza vaccines may not be as effective at protecting cancer patients as the general population from getting influenza. New technology has been developed that allows stronger (and hopefully more effective) influenza vaccines to be developed. This research study will test an experimental influenza vaccine.

If you agree to take part in this study, you will be randomly assigned (as in the toss of a coin) to receive either standard inactivated influenza vaccine or one of three doses of the experimental vaccine. You will have an equal chance of being assigned to any of the four treatment groups. Neither your physician, the study doctor, or you will know which vaccine or dose you received. In case of an emergency, the study doctor can find out which vaccine and dose you received.

Before the injection is given, a blood test will be taken to measure your antibodies (substances that fight infection). About two teaspoons of blood will be taken for this blood test. The vaccine will be given as a one time injection in the arm. After you are given the injection, you will be observed for 20 minutes in the clinic before you are sent home. Everyone taking part in this study will be asked to keep a symptom diary and temperature log for 1 week after the injection. After 7 days, you will return for review of the diary and any symptoms you may have had.

At 4 and 8 weeks after the influenza vaccine is given, most patients will have a blood test to learn the amount of immunity against the influenza virus they have developed. About two teaspoons of blood will be required for this test. A few patients may not be eligible for the eight week blood collection and will be instructed by the study nurse about future visits to UTMDACC. Six months after you have received the vaccine, you will be contacted by one of the study personnel to ask you if you had any serious side effects that might be from the study vaccine. Once you have received this follow-up telephone call, your participation in this study will be completed.

This is an investigational study. The standard vaccine used in this study is FDA approved and commercially available. The experimental vaccine is authorized for use in research only. About 100 patients will take part in this study. All will be enrolled at UTMDACC.

This protocol is partially funded by a research contract from the National Institutes of Health (NIH) to Baylor College of Medicine.

Influenza Vaccination in Patients Receiving Antineoplastic Therapy for Non-Hodgkin's Lymphoma

Evaluation of the Reactogenicity and Immunogenicity of Different Doses of Trivalent Baculovirus-expressed Influenza HA Vaccine in Adults With Non-Hodgkin's B-cell Lymphoma: A Phase II, Double-Blind Pilot Study - Version 4

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Photobiomodulation to Demonstrate Safety and Reduce the Incidence of Oral Mucositis in Adult Head & Neck Cancer Patients	NCT03972527	Oral Mucositis ... Oral Mucositis ... Oral Mucositis ... Head and Neck C...	Photobiomodulat... Routine Oral Ca...	22 Years -	MuReva Phototherapy Inc.
Influenza Vaccination in Patients Receiving Antineoplastic Therapy for Non-Hodgkin's Lymphoma	NCT00307710	Lymphoma	Trivalent Bacul...	18 Years -	M.D. Anderson Cancer Center
Photobiomodulation to Demonstrate Safety and Reduce the Incidence of Oral Mucositis in Adult Head & Neck Cancer Patients	NCT03972527	Oral Mucositis ... Oral Mucositis ... Oral Mucositis ... Head and Neck C...	Photobiomodulat... Routine Oral Ca...	22 Years -	MuReva Phototherapy Inc.

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