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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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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
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    immediately    .
  • You are eligible to participate in this study if you may be interested in participating in a research trial at UCI Health
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  • 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.
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What is an IRB? An Institutional Review Board (IRB) is a committee made up of scientists and nonscientists. The IRB’s role is to protect the rights and welfare of human subjects involved in research. The IRB also assures that the research complies with applicable regulations, laws, and institutional policies.