Single-Center Eval of Clinical & Radiological Benefit AHCC in Combo w/ SOC Tx for HPV+ Pts w/ HNSCC

UCI Specialty Area: Cancer

Principal Investigator: Rupali Nabar

Official Title: Single-Center Evaluation of the Clinical and Radiological Benefit of AHCC® in Combination with Standard of Care Treatment for HPV-Positive Patients with Head and Neck Squamous Cell Carcinoma (HNSCC)

A Study On:

Larynx

Lip Oral Cavity and Pharynx

Other Respiratory and Intrathoracic Organs

Study Description

This is a phase 2, single-arm, open-label clinical trial determining safety and tolerability of AHCC in subjects with HPV-positive patients with Head and Neck Squamous Cell Carcinoma. These are subjects who have undergone surgery or will be undergoing surgery.

Eligibility

You can participate in this study if you:

Between 18 and 79 years of age
Confirmed diagnosis of HPV positive Head and Neck Squamous Cell Carcinoma (HNSCC), a throat cancer
No evidence of any other disease during the screening process
Able and willing to provide informed consent
All females who are able to become pregnant must provide a negative pregnancy test
If you are a female capable of bearing children or sexually active male, you must agree to use approved and reliable contraception methods or abstain from sexual intercourse throughout the duration of the study treatment and for a period of 120 days following the conclusion of the study treatment

You cannot participate in this study if you:

Pregnant or breastfeeding
Active infection that requires treatment
Had an organ transplant or stem cell transplant
Currently taking medication that can affect your immune system
Known history or current symptoms of cardiac disease (heart problem) that limit physical activity. This includes being comfortable at rest but experiencing fatigue, palpitation, shortness of breath or chest pain with less than ordinary activity. Also symptoms of hear failure at rest where any physical activity causes further discomfort. Receiving treatment for cardiac disease
Received a live vaccine within 30 days prior to the first dose of our study drug (Live vaccines include measles, mumps, rubella, chicken pox, rabies, typhoid fever)
Have known history of Hepatitis B or Hepatitis C
History of HIV
Known allergy to mushroom or mushroom products
Known psychiatric or substance abuse disorder that can affect your ability to complete study assessments

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Interested in Participating in this Trial?

Thank you for your interest with our team.

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University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

Please read the information below and ask questions about anything that you do not understand. A
researcher listed above will be available to answer your questions.

You are being asked to participate in a clinical research potential participant database to identify
potential clinical research studies you may be eligible for. Participation in this database is voluntary.
You may choose to skip any question. You may refuse to participate or discontinue your involvement
at any time without penalty or loss of benefits. You are free to withdraw from this database at any
time. If you decide to withdraw from this database you should notify the research team
immediately.

You are eligible to participate in this study if you may be interested in participating in a research trial at UCI Health

We would like to interview you to learn more about your eligibility for current clinical research studies at UCI. The interview will last about 5-30 minutes, depending on the extent of your medical history.

Possible risks/discomforts associated with the database are hearing about potential clinical research studies that may not be of interest to you, invasion of your privacy, or a potential breach of confidentiality.

There are no direct benefits from participation in the database. However, this database may help inform you on clinical research studies that you may be eligible for. Participation in UCI clinical research studies help us gain important data and knowledge that may lead to improved treatment options for people with similar conditions to you in the future.

There are no alternative procedures available. The only alternative is not to participate in this study.

There is no compensation for your participation in this database.

There is no cost to you for participation in this database.

All information collected will be stored confidentially in a world-class securely-hosted application, “RealTime CTMS,” with robust data protections and encryption. This application has HIPAA compliant architecture and application rules to ensure data privacy and regulatory compliance.

Researchers will use your information to assess your eligibility for current and future clinical research studies at UCI. You may opt out at any time.

The research team, authorized UCI personnel, and regulatory entities, may have access to your study records to protect your safety and welfare.

While the research team will make every effort to keep your personal information confidential, it is possible that an unauthorized person might see it. We cannot guarantee total privacy.

Future Research Use
Researchers will use your information to conduct this study. Once the study is done using your information, we may share them with other researchers so they can use them for other studies in the future. We will not share your name or any other private identifiable information that would let the researchers know who you are. We will not ask you for additional permission to share this de-identified information

Data Retention - In accordance with UC Office of the President policy, information will be retained for 10 years after the end of the calendar year in which the research is completed.

If, during the course of this study, significant new information becomes available that may relate to your willingness to continue to participate, this information will be provided to you by the research team listed at the top of the form.

If you have any comments, concerns, or questions regarding the conduct of this research please contact the researchers listed at the top of this form

Please contact the UCI Institutional Review Board by phone, (949) 824-8170, by e-mail at IRB@research.uci.edu or at 160 Aldrich Hall, Irvine, CA 92697-7600 if you are unable to reach the researchers listed at the top of the form and have general questions; have concerns or complaints about the research; have questions about your rights as a research subject; or have general comments or suggestions.

What is an IRB?