Atlanta, GANCT04915183Now EnrollingIRB Ready

Head and Neck Cancer Clinical Trial in Atlanta, GA

Access cutting-edge head and neck cancer treatment through this phase 2 clinical trial at a research site in Atlanta. Study-provided care at no cost to qualified participants.

Sponsored by National Institute on Deafness and Other Communication Disorders (NIDCD)

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Expert Care in Atlanta

Access head and neck cancer specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related head and neck cancer treatment provided free

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Check if you qualify for this head and neck cancer clinical trial in Atlanta, GA

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Why Participate?

  • No-Cost Study Care

  • Local to Atlanta

    Convenient for GA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Atlanta site if eligible
  4. 4Begin participation

About This Head and Neck Cancer Study in Atlanta

Background: Cisplatin is used to treat head and neck cancer. People who take this drug are at risk for hearing loss. Atorvastatin is a drug used to treat high cholesterol. It might reduce the risk of cisplatin-induced hearing loss. Objective: To find out if atorvastatin reduces hearing loss in people treated with cisplatin and radiation. Eligibility: People ages 18 and older with squamous cell carcinoma of the head and neck who will undergo treatment with cisplatin-based chemotherapy and ra

Sponsor: National Institute on Deafness and Other Communication Disorders (NIDCD)

Who Can Participate

Inclusion Criteria

In order to be eligible to participate in this study, an individual must meet all of the following criteria evaluated by the study team, including an on-site oncologist:
Willingness and ability to comply with and participate in all study procedures and availability for the duration of the study
Ability to provide consent and provision of signed and dated informed consent form
Adult subjects, aged \>=18
Diagnosed with squamous cell carcinoma of the head and neck, confirmed by a pathologic review of surgical or biopsy specimen(s), who meet standard clinical and laboratory criteria and will undergo treatment with concomitant cisplatin-based chemotherapy and radiation with curative intent or treatment with neoadjuvant chemotherapy (NAC). This includes subjects who will be treated with either intensity-modulated radiation therapy (IMRT) or proton radiotherapy, with planned dose to the cochlea \<35 Gy (to limit confounding effects of radiation64-67). Patients receiving immunotherapy in addition to cisplatin chemoradiation are eligible. Subjects treated with either high-dose cisplatin (typically 100 mg/m\^2 x 2-3 doses every three weeks) or low-dose, weekly cisplatin (typically 40 mg/m\^2 x 6-7 doses weekly) may enroll. Cisplatin in the neo-adjuvant setting may be given within a combination chemotherapy regimen (e.g TPF= Docetaxel, Cisplatin and 5FU or DC = Docetaxel Cisplatin)
Subjects must have hearing thresholds at or better than 70 dB HL at 1, 2, and 4 kHz in at least one ear at the time of their baseline audiogram. CTCAE criteria (primary endpoint) and ASHA criteria (secondary endpoint) are based on changes in hearing in at least one ear with one ototoxicity event/grade assigned per person.
Baseline laboratory tests with lab values \<1.5x the upper limit of normal: aspartate aminotransferase (AST or SGOT); alanine aminotransferase; creatine phosphokinase, creatinine
Ability to take oral medication by mouth or by feeding tube and willingness to adhere to the daily atorvastatin or placebo regimen
For females of reproductive potential: use of highly effective contraception for at least 1 month prior to enrollment and agreement to use such a method during study participation and for an additional 8 weeks after the end of atorvastatin administration

Exclusion Criteria

An individual who meets any of the following criteria will be excluded from participation in this study:
Subjects currently taking a statin drug
Subjects with bilateral flat, Type B tympanogram
Subjects with bilateral cochlear implants
Pre-existing liver or kidney disease that in the opinion of the investigator would interfere with taking Atorvastatin 40 mg daily.
Subjects with a history of prior treatment with cisplatin chemotherapy
Staff members of the NIDCD Sections and of the lead site investigators headed by the PIs
Children will be excluded because HNSCC in children under age 18 is exceedingly rare
Current use of cimetidine, spironolactone, ketoconazole, cyclosporine, protease inhibitors, gemfibrozil, clarithromycin or itraconazole
Pregnancy, lactation, or plan to become pregnant
Known allergic reactions to components of atorvastatin or the placebo
Other severe or unstable medical conditions which clinical site PI believes increase risk to safety or ability to complete study
Expected concomitant use of aminoglycoside antibiotics

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Atlanta?

Yes, this clinical trial (NCT04915183) has an active research site in Atlanta, GA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Head and Neck Cancer Treatment Options in Atlanta, GA

If you're searching for head and neck cancer treatment options in Atlanta, GA, this clinical trial (NCT04915183) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Atlanta research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced head and neck cancer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all head and neck cancer clinical trials near you to find additional studies recruiting in your area.

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