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
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.