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
Interested in Participating in this Trial?
Thank you for your interest with our team.
One of our specialists will be in contact with you soon.
Privacy Policy
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
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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
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While the research team will make every effort to keep your personal information confidential, it is
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Future Research Use
Researchers will use your information to conduct this study. Once the study is done using your
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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.
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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
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The IRB’s role is to protect the rights and welfare of human subjects involved in
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