Who is eligible for clinical trial NCT04651634?

Participants must meet protocol criteria for Head and Neck Squamous Cell Carcinoma. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT04651634 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-04-03

MIT-001 for Prevention of CCRT-Induced OM in HNSCC Patients (NCT04651634)

🔵 Active, Not Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: MitoImmune Therapeutics

🩺 Plain-English Summary (8th-Grade Level)

The proposed study in patients with previously untreated locally advanced head and neck squamous cell carcinoma (HNSCC) is designed to evaluate the efficacy and safety of three different doses of MIT-001 compared to the placebo in prevention of oral mucositis (OM) in patients with HNSCC who are undergoing concurrent chemoradiotherapy (CCRT).

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (8 items).

Location: Banner MD Anderson Cancer Center — Gilbert, Arizona

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Histologically confirmed HNSCC (The American joint committee on cancer \[AJCC\] 8th edition, Stage II, III, IVA, or IVB), involving either the oral cavity or oropharynx, or HPV-positive Stage I oropharyngeal cancer.
Treatment plan to receive a continuous course of intensity-modulated radiation therapy (IMRT) for definitive treatment of HNSCC delivered as single daily fractions of 1.8 to 2.5 Gy with a cumulative radiation dose between 60 and 72 Gy (EQD2 of 60 to 72 Gy, α/β ratio=10): Planned radiation treatment fields must include at least 30% of oral cavity that are planned to receive a total of 50 Gy or higher.
CCRT plan to receive standard cisplatin monotherapy: Standard cisplatin monotherapy administered weekly (30 to 40 mg/m2), once per week for 5 to 7 continuous weeks.
Eastern Cooperative Oncology Group Performance Status (ECOG-PS) 1 or less
Serum pregnancy test negative for women of childbearing potential (woman of childbearing potential \[WOCBP\]

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Patients who have active mucositis at screening.
Planned to receive Erbitux™ (Cetuximab) or other targeted or immune therapy during the study.
Tumor of the lips, sinuses, or salivary glands or unknown primary tumors.
Metastatic disease (M1) Stage.
Known history of severe vascular toxicity or allergies or intolerance to cisplatin and similar platinum-containing compounds.
Any clinically significant and/or active infection, other systemic illness or condition (other than HNSCC) that would preclude them from participating in the study in the opinion of the Investigator.
Prior resective surgery (4 weeks or less than 4 weeks from receiving surgery to randomization) for primary tumor under treatment for HNSCC.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (16 Sites)

Banner MD Anderson Cancer Center — Gilbert, Arizona
Norris Comprehensive Cancer Center — Los Angeles, California
Cancer Center of Kansas — Wichita, Kansas
James P. Wilmot Cancer Center — Rochester, New York
Wake Forest Baptist Health - Comprehensive Cancer Center — Winston-Salem, North Carolina
James Cancer Hospital Solove Research Institute — Columbus, Ohio
The Catholic University of Korea Saint Vincent's Hospital — Suwon, Gyeonggi-do
Jeonbuk National University Hospital — Jeonju, Jeollabuk-do
Keimyung University Dongsan Hospital — Daegu,
Chungnam National University Hospital — Daejeon,
National Cancer Center — Goyang-si,
Seoul National University Bundang Hospital — Gyeonggi-do,
Inha University Hospital — Incheon,
Seoul National University Hospital — Seoul,
Korea University Guro Hospital — Seoul,
Hanyang University Seoul Hospital — Seoul,

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗