MIT-001 for Prevention of CCRT-Induced OM in HNSCC Patients (NCT04651634)
A Phase 2, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Safety and Efficacy of MIT-001 in Prevention of Oral Mucositis in Patients Receiving CCRT for Locally Advanced HNSCC
🩺 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: Review the eligibility criteria below.
Location: Banner MD Anderson Cancer Center — Gilbert, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 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,
📞 Contact the Study Coordinator
Phone: (877) 632-6789
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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.
More studies in Head and Neck Squamous Cell Carcinoma
- Study of Zanzalintinib (XL092) + Pembrolizumab vs Pembrolizumab in Subjects With PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma — Fullerton, California
- Testing the Addition of an Anti-cancer Drug, Ipatasertib, to the Usual Immunotherapy Treatment (Pembrolizumab) in Patients With Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck — Duarte, California
- Study of Novel Treatment Combination Therapies in Participants With Head and Neck Squamous Cell Carcinoma Regardless of PD-L1 Expression Status; Substudy-01 — St Louis, Missouri
- Intensive Symptom Surveillance Guided by Machine Learning-Directed Risk Stratification in Patients With Non-Metastatic Head and Neck Cancer, The INSIGHT Trial — Buffalo, New York
- Neoadjuvant Targeting of Myeloid Cell Populations in Combination With Nivolumab in Head & Neck Ca — Baltimore, Maryland
Explore by condition: All Head and Neck Squamous Cell Carcinoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.